INTERNATIONAL ISO

STANDARD 25539-1

Second edition
2017-02

Cardiovascular implants —
Endovascular devices —
Part 1:
Endovascular prostheses
Implants cardiovasculaires — Dispositifs endovasculaires —
Partie 1: Prothèses endovasculaires

Reference number
ISO 25539-1:2017(E)

© ISO 2017
ISO 25539-1:2017(E)


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Contents Page

Foreword...........................................................................................................................................................................................................................................v
Introduction................................................................................................................................................................................................................................. vi
1 Scope.................................................................................................................................................................................................................................. 1
2 Normative references....................................................................................................................................................................................... 2
3 Terms and definitions...................................................................................................................................................................................... 2
4 General requirements for endovascular system.................................................................................................................. 4
4.1 Type of endovascular prosthesis.............................................................................................................................................. 4
4.2 Materials and construction for endovascular system............................................................................................ 4
4.3 Configuration and size designation for endovascular prosthesis................................................................ 5
4.4 Intended clinical use for endovascular system............................................................................................................ 5
4.5 Balloon designation............................................................................................................................................................................. 6
5 Intended performance.................................................................................................................................................................................... 6
6 Design attributes................................................................................................................................................................................................... 6
6.1 General............................................................................................................................................................................................................ 6
6.2 Endovascular system.......................................................................................................................................................................... 6
6.3 Endovascular prosthesis.................................................................................................................................................................. 6
6.4 Endovascular system and endovascular prosthesis................................................................................................ 7
7 Materials........................................................................................................................................................................................................................ 7
8 Design evaluation................................................................................................................................................................................................. 7
8.1 General............................................................................................................................................................................................................ 7
8.2 Sampling........................................................................................................................................................................................................ 8
8.3 Conditioning of test samples........................................................................................................................................................ 9
8.4 Reporting...................................................................................................................................................................................................... 9
8.5 Bench and analytical tests........................................................................................................................................................... 10
8.5.1 Endovascular system and delivery system.............................................................................................. 10
8.5.2 Endovascular prosthesis......................................................................................................................................... 12
8.6 Preclinical in vivo evaluation................................................................................................................................................... 18
8.6.1 Purpose.................................................................................................................................................................................. 18
8.6.2 Specific aims...................................................................................................................................................................... 18
8.6.3 Protocol considerations........................................................................................................................................... 19
8.6.4 Data acquisition.............................................................................................................................................................. 19
8.6.5 Test report and additional information..................................................................................................... 21
8.7 Clinical evaluation.............................................................................................................................................................................. 21
8.7.1 Purpose.................................................................................................................................................................................. 21
8.7.2 Specific aims...................................................................................................................................................................... 22
8.7.3 Protocol considerations........................................................................................................................................... 22
8.7.4 Data acquisition.............................................................................................................................................................. 23
8.7.5 Final report......................................................................................................................................................................... 26
9 Post-market surveillance...........................................................................................................................................................................27
10 Manufacturing.......................................................................................................................................................................................................27
11 Sterilization.............................................................................................................................................................................................................27
11.1 Products supplied sterile............................................................................................................................................................. 27
11.2 Sterilization residuals..................................................................................................................................................................... 27
12 Packaging................................................................................................................................................................................................................... 28
12.1 Protection from damage in storage and transport................................................................................................ 28
12.1.1 General................................................................................................................................................................................... 28
12.1.2 Unit container................................................................................................................................................................... 28
12.1.3 Outer container............................................................................................................................................................... 28
12.1.4 Shipping container....................................................................................................................................................... 28

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12.1.5 Maintenance of sterility in transit................................................................................................................... 28

12.2 Labelling..................................................................................................................................................................................................... 28
12.2.1 Container label................................................................................................................................................................ 28
12.2.2 Record label........................................................................................................................................................................ 29
12.3 Instructions for use........................................................................................................................................................................... 29
12.3.1 General................................................................................................................................................................................... 29
12.3.2 Information and instructions for use for endovascular systems......................................... 29
Annex A (informative) Relationship between testing requirements and device attributes
and potential failure modes....................................................................................................................................................................31
Annex B (informative) Description of clinical and device effects of failure..............................................................45
Annex C (informative) Bench and analytical tests................................................................................................................................49
Annex D (informative) Test methods.................................................................................................................................................................57
Bibliography.......................................................................................................................................................................................................................... 121

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Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www. iso. org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www. iso. org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment,
as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the
Technical Barriers to Trade (TBT) see the following URL: www .iso. org/iso/foreword. html.
The committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants and extracorporeal systems.
This second edition cancels and replaces the first edition (ISO 25539-1:2003), which has been
technically revised.
It also incorporates the Amendment ISO 25539-1:2003/Amd1:2005.
A list of all the parts of ISO 25539 can be found on the ISO website.

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Introduction
This document was prepared to provide minimum requirements for endovascular prostheses. The
normative requirements are provided in the main body. The rationale for the requirements for bench
tests and analyses to assess device performance, guidance on the identification of appropriate testing to
evaluate a specific device design and guidance for developing test methods are provided in informative
annexes. Further clarification of terminology and a cross reference between the main body and these
annexes are provided in additional informative annexes.
This document has been updated to reflect current knowledge regarding the testing and clinical use of
endovascular prostheses, reflected in modifications to the requirements in the main body and in the
guidance for developing test methods in Annex D. In addition, revisions have been made to improve
consistency in nomenclature and reporting and to enhance the utility of this document.
This document introduces methodology to identify appropriate testing and analyses for specific
endovascular prosthesis, designated as the device evaluation strategy (DES). The requirement regarding
the DES is in the main body, with informative guidance for the preparation of a DES table included in
Annex A. Annex A also provides guidance for developing a DES for device design modifications and
changes in intended use.
The other significant modifications in the requirements include the addition of non-radial durability
testing, with guidance on the selection of appropriate testing, and specific requirements for testing
to evaluate patency-related characteristics. Guidance for the development of appropriate tests to meet
these requirements is included in Annex D.
The guidance on the development of methods to address the requirement for evaluating fatigue and
durability through computational analyses has been modified significantly to include recommendations
regarding verification of the solution and validation of the computational model, as well as reporting.
The guidance on the model development for simulated use has also been significantly revised to
improve the clinical relevance of this testing.
New requirements also include the evaluation of leakage at a seal zone and dislodgement force of
endovascular prosthesis from a balloon. Guidance for the development of appropriate tests to meet
these requirements is included in Annex D.
The requirement for evaluating the strength of the connection(s) between the graft material and a
discrete fixation system(s) has been clarified with respect to the applicability of this requirement, that
is, this requirement is only applicable for prostheses with a fixation system that is discrete from any
stent(s) intended to provide structural support within the prosthesis [e.g. suprarenal stent that is not
continuous with the stent(s) in the prosthesis body].
The specific requirements to evaluate pushability, flexibility, torquability, trackability and deployment
accuracy of an endovascular system have been removed and incorporated within the simulated use
evaluation requirement to better reflect how these attributes are evaluated. Similarly, the requirement
to evaluate tubing tensile strength has been removed and incorporated within the evaluation of tensile
bond strength.
The requirement to evaluate stent-free surface area has been removed as this attribute is not relevant
for endovascular prostheses, which includes covered stents.
In addition to modifications to specific design evaluation requirements, guidance has been provided
regarding the assessment of the acceptability of test results. When the requirement is to quantitatively
appraise or analyse a parameter, test results generally may be compared to a quantitative value (i.e.
acceptance criteria). For characterization tests, it is appropriate to provide an explanation of the
relevance of the results. Additionally, some testing may include comparison to test data or existing data
from a previously evaluated device.
For design evaluation, requirements regarding sampling, conditioning of test samples and reporting
have been incorporated in the main body. Guidance on these elements of testing and documentation
were previously included in Annex D.

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The revisions to the titles of the annexes to this document are as follows.

Annex ISO 25539-1:2003+A1:​2005 ISO 25539-1:2017

A Attributes of endovascular devices — Relationship between testing requirements and
Technical and clinical considerations device attributes and potential failure modes
B Bench and analytical tests Description of device and clinical effects of
failure
C Definitions of reportable clinical events Bench and analytical tests
D Test methods Test methods
E Sample equations as a supplement to the radial There is no Annex E as this information was
fatigue and durability test incorporated in Annex D

It is recognised by this ISO committee that many endovascular systems have been shown to be safe and
effective in clinical use. This update is not intended to require additional evaluation of these devices to
remain in compliance with this document as the testing would not provide useful information regarding
the expected clinical performance of the device. Manufacturers may rely on historical data gathered
under the guidance of the previous version of this document. Similarly, for device modifications or
changes in intended clinical use, this update is not intended to require additional evaluation of any
aspects of the device that are not expected to change clinical performance.

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Cardiovascular implants — Endovascular devices —

Part 1:
Endovascular prostheses

1 Scope
This document specifies requirements for the evaluation of endovascular systems (prostheses and
delivery systems) and requirements with respect to nomenclature, design attributes and information
supplied by the manufacturer based upon current medical knowledge. Guidance for the development
of in vitro test methods is included in an informative annex to this document. This document can be
considered as a supplement to ISO 14630, which specifies general requirements for the performance of
non-active surgical implants.
This document is applicable to endovascular systems used to treat aneurysms, stenoses or other
vascular anomalies or pathologies (e.g. dissections, transections) or to create shunts between vessels
[e.g. creation of transjugular intrahepatic portosystemic shunting (TIPS)]. Some of the requirements are
specific to endovascular treatment of arterial aneurysms or stenoses. Although uses of endovascular
systems other than treatment of arterial aneurysms or stenoses (e.g. dissections, transections, shunts)
are within the scope of this document, the specific requirements and testing are not described.
Similarly, specific prosthesis configurations (e.g. fenestrated, branched) are within the scope, but
specific requirements and testing are not described for these devices.
This document is not applicable to vascular occluders, with the exception of contra-lateral iliac artery
occluders when used as an integral part of aorto-uni-iliac endovascular prosthesis. Although contra-
lateral iliac artery occluders when used as an integral part of aorto-uni-iliac endovascular prosthesis
are within the scope of this document, specific requirements and testing are not described for these
devices.
Balloons used to achieve adequate apposition of the prosthesis with the vessel wall or overlapping
components are within the scope of this document, even if they are not integral to the endovascular
system. This document provides requirements beyond the requirements of ISO 10555-4, specific to the
use of balloons with endovascular prostheses.
This document is not applicable to procedures and devices used prior to the introduction of the
endovascular system, such as balloon angioplasty devices.
The valve component of valved conduits constructed with an endovascular prosthesis component and
the combination of the valved component and the endovascular prosthesis component are excluded
from the scope of this document. This document can be helpful in identifying the appropriate evaluation
of the endovascular prosthesis component of a valved conduit, but specific requirements and testing
are not described for these devices.
NOTE 1 Cardiac valved conduits are within the scope of ISO 5840-1.

Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in
this document.
NOTE 2 Vascular device-drug combination products are within the scope of ISO 12417.

This document does not address the requirements for, and the evaluation of, viable tissues and non-
viable biologic materials used in the construction of endovascular prostheses.

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The requirements for, and the evaluation of, degradation and other time-dependant aspects of
absorbable materials used in the construction of endovascular prostheses are not addressed in this
document.
NOTE 3 Absorbable materials are within the scope of ISO/TS 17137 and ISO/TR 37137.

2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 7198:2016, Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular
vascular grafts and vascular patches
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 11137 (all parts), Sterilization of health care products — Radiation
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 14160, Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical
devices utilizing animal tissues and their derivatives — Requirements for characterization, development,
validation and routine control of a sterilization process for medical devices
ISO 14630:2012, Non-active surgical implants — General requirements
ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing
agent and the development, validation and routine control of a sterilization process for medical devices
ISO 14971, Medical devices — Application of risk management to medical devices
ASTM F2503, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic
Resonance Environment

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 7198 and ISO 14630 and the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http://​w ww​.electropedia​.org/​
— ISO Online browsing platform: available at https://​w ww​.iso​.org/​obp/​
NOTE Additional descriptions of device and clinical effects of failure are included in Annex B.

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3.1
adverse event
adverse change in health that occurs in a subject who participates in a study while receiving the
treatment or within a specified time after receiving treatment
Note 1 to entry: For the purpose of this document, clinical effects of failure are a subset of adverse events and are
described separately.

Note 2 to entry: Adverse events are categorized by the system affected (e.g. cardiac, vascular, respiratory,
neurological, renal, gastro-intestinal) and the severity of the event.

3.2
clinical effect of failure
specific clinical observations potentially associated with device failures
Note 1 to entry: The term device failure relates to the definition of a hazard as found in ISO 14971.

Note 2 to entry: Clinical effects of failure are described in Annex B.

3.3
delivery system
system or mechanism used to deliver the endovascular prosthesis (3.9) to the targeted position and then
to deploy the prosthesis
Note 1 to entry: The delivery system is removed after implant deployment.

3.4
determine
quantitatively appraise or analyse
3.5
device effect of failure
consequence to the device potentially associated with device failures
Note 1 to entry: Device effects of failure are described in Annex B.

3.6
device evaluation strategy
DES
rationale for the testing selected to evaluate a specific endovascular system (3.10), based on the
requirements of the device design and potential failure modes (3.13)
3.7
device evaluation strategy table
DES table
optional communication tool to present the DES (3.6) for a specific endovascular system (3.10)
3.8
endoleak
persistence of blood flow outside the lumen of an endovascular prosthesis (3.9), but within an aneurysm
sac or vascular segment being treated by the graft
Note 1 to entry: Endoleaks in the presence of aneurysm are categorized as follows.

— Type I endoleak arising at or from a sealing zone, occurring at the proximal (Type Ia) or distal (Type Ib)
attachment zone.

— Type II endoleak is caused by retrograde flow from patent branch arteries, for example, lumbar and intercostal
arteries.

— Type III endoleak arises from an inadequate seal between modular graft components (Type IIIa) or from a
defect in the graft material (3.15) (Type IIIb).

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— Type IV endoleak is due to graft permeability, often identified by a generalized blush of contrast within the
aneurysm sac.

3.9
endovascular prosthesis
endovascular graft
endovascular implant
vascular prosthesis (including modular components) which resides partially or completely within a
blood vessel, or vascular conduit to form an internal bypass or shunt between sections of the vascular
system, delivered and deployed using a delivery system (3.3)
3.10
endovascular system
system comprised of an endovascular prosthesis (3.9) and its delivery system (3.3)
3.11
evaluate
qualitatively appraise or analyse
3.12
factory anastomosis
factory manufactured seam-line in which two or more edges of graft material (3.15) are joined (e.g.
sewn) together
Note 1 to entry: Bonds between stents or between the graft material and a stent or an attachment system are not
covered under this definition.

3.13
failure mode
difficulty or failure of the endovascular system (3.10) that may be encountered (hazards) in pre-clinical in
vivo or clinical use of an endovascular system (3.10) and could result in consequences (harm) to the subject
3.14
fixation system
system or feature of the endovascular prosthesis (3.9) that is designed to interface directly with the
vessel wall in order to prevent migration
3.15
graft material
textile or non-textile, non-metallic material [e.g. polyethylene terephthalate (PET),
polytetrafluoroethylene (PTFE), polyurethane] used to line or cover the mechanical support structures
of the endovascular prosthesis (3.9) or to provide a vascular conduit for blood flow

4 General requirements for endovascular system

The following requirements shall apply to all endovascular systems.

4.1 Type of endovascular prosthesis

The type of endovascular prosthesis shall be designated by balloon-expandable, self-expanding or other.

4.2 Materials and construction for endovascular system

Materials of the endovascular system (e.g. graft material, wire, stent, mechanical support, imaging
markers, coatings, drugs) shall be described by their generic or chemical names.

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4.3 Configuration and size designation for endovascular prosthesis

The configuration of endovascular prosthesis shall be designated by its geometry (e.g. straight,
bifurcated, branched, fenestrated, tapered, flared).
The size of an endovascular system shall be designated by the outer diameter of the delivery system
and the appropriate nominal relaxed diameters of each component of the endovascular prosthesis (e.g.
main body, branches, extenders, cuffs) and the appropriate lengths.

4.4 Intended clinical use for endovascular system

The intended clinical use shall be designated by the disease state or lesion type to be treated (e.g.
occlusive disease, stenosis, restenosis, aneurysm, dissection, transection) and one or more of the
following implant locations:
a) ascending thoracic aortic;
b) aortic arch;
c) great vessels;
— left subclavian;
— left carotid;
— innominate (brachiocephalic);
d) descending thoracic aortic;
e) thoraco-abdominal aortic;
f) abdominal aortic and/or aorto-iliac;
— infrarenal;
— juxtarenal;
— pararenal and paravisceral;
g) visceral;
— renal;
— superior mesenteric;
— celiac;
h) peripheral;
— iliac;
— internal iliac;
— femoral;
— popliteal;
— tibial;
— carotid;
i) coronary;
j) arterio-venous shunt for vascular access;

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k) transjugular intrahepatic shunt;

l) other vessels to be specified.
Anatomical indications (e.g. vessel diameter ranges for treatment of occlusive disease, range of landing
zone diameters and lengths for the treatment of aneurysms, maximum angulation) shall be specified.
For branched or fenestrated devices, the additional vessels to be treated shall be specified.
For endovascular prostheses intended to be used in conjunction with adjunctive procedures (e.g.
percutaneous transluminal angioplasty), the adjunctive procedure shall be specified.
If an endovascular prostheses may be used in a secondary procedure (e.g. treatment of in-stent
restenosis, secondary repair of previously placed endovascular prosthesis with inadequate seal or
fixation), the conditions of use shall be specified.

4.5 Balloon designation

Balloons integral to the endovascular system and balloons intended to achieve adequate apposition of
the prosthesis shall be designated by the nominal diameter(s) as a function of the inflation pressure(s) or
volume(s), the maximum recommended inflation pressure or volume and the rated burst pressure (RBP).
If a commercially available balloon is recommended for use in the instructions for use (IFU), the balloon
shall be designated by the balloon type [e.g. percutaneous transluminal angioplasty (PTA), moulding,
low-pressure aortic, compliant].

5 Intended performance
The requirements of ISO 14630:2012, Clause 4 shall apply.

6 Design attributes

6.1 General
The requirements of ISO 14630:2012, Clause 5 shall apply. General design attributes for endovascular
systems are listed in Tables A.3 and A.4 with reference to the nonclinical testing necessary for the
evaluation of the design. It is recognised that not all tests identified in a category will be necessary or
practical for any given endovascular prosthesis and/or system. The rationale for the selection of tests
shall be documented.

6.2 Endovascular system

In addition to the general requirements, the design attributes of the endovascular system shall at least
take into account the following:
a) ability to consistently, accurately and safely access the intended location;
b) ability to consistently, accurately and safely deploy the endovascular prosthesis;
c) ability to safely withdraw the delivery system;
d) ability to minimize blood loss (haemostasis).

6.3 Endovascular prosthesis

In addition to the general requirements, the design attributes of the endovascular prosthesis shall at
least take into account the following:
a) ability of the endovascular prosthesis to ensure effective fixation within the vasculature;

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b) ability of the endovascular prosthesis to maintain adequate integrity;

c) ability of the endovascular prosthesis to isolate the lesion as appropriate to its intended use (e.g.
provide seal between the endovascular prosthesis and aneurysm, prevent blood from flowing
through the implant wall);
Changes in wall permeability after implantation shall be considered when establishing an appropriate
in vitro specification for permeability.
d) appropriate interaction between endovascular prosthesis modular components;
e) compatibility of the endovascular prosthesis dimensions for use in specified vessel diameters;
f) ability of the endovascular prosthesis to maintain adequate blood flow through the lumen
(patency);
g) ability to safely use magnetic resonance imaging (MRI) on a patient with an implanted endovascular
prosthesis.

6.4 Endovascular system and endovascular prosthesis

In addition to the general requirements, the design attributes of the endovascular system and
endovascular prosthesis shall at least take into account the following:
a) visibility of the endovascular system, delivery system and endovascular prosthesis under
fluoroscopy or other technologies;
b) compliance of the delivery system and endovascular prosthesis with the requirements of
ISO 10993-1 and other appropriate parts of the ISO 10993- series;
c) sterility of the endovascular system and endovascular prosthesis.

7 Materials
The requirements of ISO 14630:2012, Clause 6 shall apply. Additional testing specific to certain
materials should be performed to determine the appropriateness of the material for use in the design.
For example, nitinol materials dependent on shape-memory properties should be subjected to testing in
order to assess transformation properties.

8 Design evaluation

8.1 General
The requirements of ISO 14630:2012, Clause 7 shall apply. A risk analysis shall be carried out in
accordance with the requirements of ISO 14971.
The requirements and testing described in ISO 10555-1 may apply to the design evaluation of an
endovascular system.
The device design concept shall be considered in the selection of appropriate tests and associated test
methods. The device design concept includes the following:
— device description (e.g. physical description, figures, materials of construction), what the device key
design features are intended to do, how the key design features accomplish the intended objective;
— intended clinical use (see 4.4);
— conditions of use/intended in vivo environment;
— minimum design life of the device.

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A device evaluation strategy (DES) shall be created. A DES provides the rationale for the testing selected
to evaluate the endovascular system based on the requirements of the device design and potential
failure modes. DES may be communicated in a table (DES table) with column headings as presented
and explained in Table A.1. Tables A.3 and A.4 may serve as the foundation for DES applicable to specific
endovascular prosthesis and would be expanded upon as appropriate to address the unique aspects of
the device. Alternative methods for presenting DES may be used (e.g. a non-tabular presentation of the
rationale for the testing based on the potential risks and benefits of the endovascular system for the
intended clinical use).
Emerging-technology endovascular systems should be evaluated following the basic requirements of
this document. The device evaluation strategy should identify any testing needed beyond the scope of
this document to characterize these endovascular systems.
NOTE 1 All testing might not be appropriate for all endovascular system designs or intended clinical uses.

Whenever changes are made in materials, construction, configuration, intended clinical use or processing
methods, an appropriate analysis of the potential impact of the change on the potential failure modes
and performance of the endovascular system shall be performed. The device evaluation strategy may
be outlined in a table with column headings as presented in Table A.5. Appropriate testing shall be
conducted as deemed necessary, considering the potential failure modes associated with the change.
The use of a control device for comparison may be considered in the evaluation of certain design
attributes, particularly for design iterations.
The device design evaluation should be appropriate for the conditions of use described in the design
concept and in the instructions for use (IFU). Though not required for the design evaluation, testing
beyond these limits may be considered to characterize the changes in device performance (e.g.
migration resistance, seal, kink resistance, durability, proper positioning, configuration or orientation)
as a function of use outside of the recommended conditions (e.g. angles, sizing). Information obtained
from such testing might be useful in establishing acceptance criteria and in identifying appropriate
warnings or precautions in the IFU for physician users.
Testing to establish the labelled shelf-life shall be conducted by repeating appropriate tests. Generally,
this will not include long-term durability testing, unless the materials of construction are susceptible
to degradation that cannot be evaluated through shorter-term testing, or other tests that measure
parameters that are not expected to be affected by aging (e.g. MRI safety testing, corrosion testing).
Justification for the selection of tests shall be provided.
NOTE 2 ASTM F2914 provides guidance for the determination of appropriate tests for the evaluation of shelf-life.

8.2 Sampling
A sampling plan should be used that will ensure that adequate representation of the data has been
obtained for each characteristic measured. It should be verified that the design attributes of the
endovascular system are representative of the devices to be released for distribution including all sizes,
configurations and components.
If the purpose of the test is to evaluate the interaction between modular components or overlapping
prostheses (e.g. separation force for overlapping endovascular prostheses), or if the attribute under
test could be significantly affected by the overlap (e.g. ability to resist kinking), the test articles should
include overlapped components.
The sampling should fully represent the range of device sizes and may not necessarily require the
testing of each size. It may be necessary to conduct an analysis to identify the size(s) of the device with
the greatest potential for failure. A rationale should be provided for sample selection.
Segments or portions of complete prostheses may be used as the test articles if appropriately justified.
The need for testing of more than one area in endovascular prosthesis to ensure adequate
characterization for some parameters (e.g. proximal and distal diameters in a tapered prosthesis,

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wall thickness in devices with non-uniform wall thickness) should be considered in establishing the
sampling plan.
For all tests, the number of samples should be justified.

8.3 Conditioning of test samples

All samples should be subjected to sterilization, including multiple sterilizations, if appropriate, unless
justification is provided for use of non-sterilized products.
Samples should be subjected to conditions that are normally encountered that can affect the test
results. Examples of conditioning are preparation of the endovascular system, loading of the prosthesis
inside the delivery catheter, passage through simulated tortuous vasculature, warming of the system to
body temperature and deployment of the prosthesis.

8.4 Reporting
For the purposes of this document, reporting refers to submission to a National Regulatory Authority.
The design evaluation report should include an appropriate table of contents and four main sections: a)
background, b) an executive summary, c) individual test summaries and d) appendices that include the
device evaluation strategy and the detailed reports. Pages should be numbered sequentially throughout
the document (including appendices).
a) The background section should describe the device design concept.
b) The executive summary should include the following:
— a description of the bench testing and analyses that have been performed;
— a summary of the device evaluation strategy, including justification for the omission of tests
identified in this document;
— a table to summarize the testing completed, with the following columns: name of test, test
purpose, test sample description, number of samples, acceptance criteria, summary of results
and cross references to the test summary and full test report.
c) Individual test summaries should include the following:
— a brief summary of the purpose, methods, and results;
— the significance of the test results:
— for tests with acceptance criteria, justification for the criteria;
— for characterization tests, an explanation of the relevance of the results.
d) Individual test reports should include the following information:
— purpose: state the purpose of the test as it corresponds to this document;
— materials: list significant materials (e.g. test articles with lot/serial numbers or other
appropriate means of traceability, critical equipment) used in performing the test, using figures
and diagrams as appropriate;
— sampling: state the sampling plan, including the basis for and the number of samples tested and
justification for the selection of test articles (e.g. sizes, conditioning);
— acceptance criteria: if applicable, state the criteria for the test results, including justification
and/or clinical relevance;

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Clinical applicability of the acceptance criteria shall take into consideration the anatomical and
physiological conditions of the intended use.
— test method: describe in detail the method used to perform the test, including any prospectively
defined inspection procedures, and provide a justification for relevant test parameters;
— protocol deviations: describe any deviations and their potential significance on the interpretation
of the results;
— expression of results: report testing results expressed in units as indicated in the test method;
— conclusions: state conclusions, based on comparing results to acceptance criteria or provide an
explanation of the relevance of the results for characterization tests and, if appropriate, include
a discussion on the potential clinical significance of the results.

8.5 Bench and analytical tests

Testing of the endovascular system, delivery system and endovascular prosthesis shall be conducted
to evaluate the design attributes described in Clause 6, as applicable. The appropriate tests to evaluate
each design attribute are based on the potential associated failure modes, device effects of failure and
clinical effects of failure. The rationale for the requirements specified in this document for the bench
tests and analytical analyses to assess device performance is described in Annex A.

8.5.1 Endovascular system and delivery system

The ability of the endovascular system to permit safe and consistent delivery, deployment and
withdrawal and to provide adequate haemostasis shall be assessed. Sterility, biocompatibility and
visualization shall also be assessed.
The associated device/procedure related functions, potential failure modes and potential device effects
of failure and clinical effects of failure to be considered are listed in Table A.3.
Testing shall include the items listed in 8.5.1.1 through 8.5.1.11, as appropriate to the design of the
endovascular system.

8.5.1.1 Balloon testing

The following requirements apply to balloons integral to the endovascular system and accessory
balloons used to achieve adequate apposition of the prosthesis.
If the IFU for the endovascular prosthesis requires the use of a commercially available balloon,
simulated use testing as required by 8.5.1.5 shall include use of the specified balloon or a balloon
with characteristics representative of the type of balloon specified in the IFU. The balloon testing as
required by 8.5.1.1 is not required for the commercially available balloon.

8.5.1.1.1 Balloon burst pressure for non-compliant balloons

Determine the mean and rated burst pressure (RBP) of the balloon when inside of the endovascular
prosthesis.

8.5.1.1.2 Balloon deflation times

Determine the time required to completely deflate the balloon when inside of the endovascular
prosthesis.

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8.5.1.1.3 Balloon rated fatigue

Determine the ability of the balloon, when inside of the endovascular prosthesis, to withstand repeated
inflation cycles to the maximum recommended pressure or volume, taking into consideration the
number of inflation cycles expected clinically.

8.5.1.1.4 Balloon volume to burst for compliant balloons

Determine the volume required to burst a compliant balloon when inside of the endovascular prosthesis.

8.5.1.2 Dimensional verification of the endovascular system

Determine the endovascular system dimensions, including the useable length, profile and all other
appropriate dimensions, for verification to design specifications.

8.5.1.3 Dislodgement force (pre-mounted, balloon-expandable endovascular prosthesis)

Determine the force required to displace the pre-mounted endovascular prosthesis from its position on
the non-expanded balloon.

8.5.1.4 Force to deploy for self-expanding endovascular prostheses

Determine the force to deploy the endovascular prosthesis under simulated anatomical conditions. All
applicable steps of the deployment process should be evaluated.
This force may be used to establish relevant bond strength acceptance criteria.

8.5.1.5 Simulated use

Evaluate the ability to access, deploy and withdraw the endovascular system, including pushability,
flexibility, torquability, trackability and deployment accuracy, using an anatomical model(s) that
is (are) representative of the anatomical variation in the intended patient population. Evaluate the
compatibility of the endovascular system with accessory devices. Evaluate the conformability of the
deployed endovascular prosthesis to the vessel wall, positioning (including orientation, if applicable),
and absence of anomalies (e.g. kinks, twists, component separation, non-uniform expansion, prosthesis
damage).
If visible particle generation is observed during access, deployment and withdrawal of the endovascular
system, this observation should be noted. The relevance of any observations should be explained in the
context of the intended clinical use.

8.5.1.6 Tensile bond strength

Determine the bond strength of the joints and/or fixed connections of the delivery system. Evaluate the
strength of the segments adjacent to the bonds of the delivery system (e.g. sheath, tubing) separately or
concurrently with the bond strength determination.
The acceptance criteria for the bond strength(s) should take into consideration the expected
forces applied to the delivery system during clinical use [e.g. tracking (access and withdrawal) and
deployment].

8.5.1.7 Torsional bond strength

Determine the torque required to cause failure of the joints and/or fixed connections in the appropriate
segments of the delivery system (i.e. joints and/or fixed connections that are subjected to torsion during
clinical use). Evaluate the torsional strength of the segments adjacent to the bonds of the delivery
system (e.g. sheath, tubing) separately or concurrently with the torsional bond strength determination.

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The results shall be evaluated in relation to the torque necessary to access, deploy and withdraw
the system.

8.5.1.8 Haemostasis

Evaluate the ability of any haemostatic seal or valve in the delivery system to minimize leakage of blood.

8.5.1.9 Biocompatibility

The biocompatibility of the delivery system and the endovascular prosthesis shall be ensured in
accordance with ISO 10993-1 and appropriate parts of the ISO 10993- series.

8.5.1.10 Sterilization assurance

Sterilization shall be ensured in accordance with appropriate International Standards.

8.5.1.11 Visibility

Evaluate the ability to visualize the endovascular system and endovascular prosthesis using the
imaging techniques specified in the instructions for use (IFU).

8.5.2 Endovascular prosthesis

The ability of the implant to function as intended shall be assessed.

The associated device/procedure related functions, potential failure modes and potential device and
clinical effects of failure to be considered are listed in Table A.4.
Testing shall include the items listed in 8.5.2.1 through 8.5.2.9, as appropriate to the design of the
endovascular prosthesis. The tests are grouped based on similarities in the objectives of the testing;
however, tests are not repeated within multiple categories. Refer to Annex A for a complete listing of
the tests applicable to each design attribute.

8.5.2.1 Corrosion

Evaluate the susceptibility of the metallic materials of the endovascular prosthesis to corrosion.

8.5.2.2 Fatigue and durability — Computational analyses

Calculate the magnitude and location of the maximum stresses and/or strains for each appropriate
loading scenario based upon the intended clinical application and device design. Appropriate
computational analysis tools, such as finite element analysis (FEA), can be used to calculate the stresses
and/or strains. The stresses and/or strains can be compared to material characteristics to calculate the
fatigue safety factor.
Computational analyses may also be used to establish appropriate test conditions and to select test
articles for fatigue and durability testing.

8.5.2.3 Fatigue and durability — in vitro testing

Evaluate the long-term structural integrity of the endovascular prosthesis under cyclic loading
conditions that represent the in vivo environment. This can require several different test configurations.
Potential integrity failures to be assessed might include fractures, abrasion, perforation, suture breaks,
bonding failures, suture hole elongation, weave separation and delamination.
In vitro fatigue testing of the prosthesis or appropriately justified test article shall be performed to
demonstrate a minimum design life of 10 years. For pulsatile-related test configurations, a minimum
of 380 million cycles is generally required. For non-pulsatile related test configurations, the minimum

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number of cycles required to demonstrate a design life of 10 years shall be justified. If the intended
design life is less than 10 years, then shorter duration fatigue testing may be appropriate and shall be
justified.
If fatigue testing is performed to compare the durability of an endovascular prosthesis to a prosthesis
with clinically demonstrated durability or clinically known problems with durability, the duration of
test shall be justified.

8.5.2.3.1 General considerations

In identifying the appropriate durability tests, developing test methods and establishing acceptance
criteria, consideration of the device design (e.g. geometry, material selection, active fixation) and
intended clinical use (e.g. implantation location, disease state, lesion type) is necessary.
Pulsatile and non-pulsatile loading are associated with several modes of deformation. Pulsatile loading
(i.e. loading caused by the cardiac cycle) results in radial dilatation and can also produce non-radial
(i.e. bending, torsional and axial) deformation. Non-pulsatile loading (e.g. loading from respiration,
walking) can result in non-radial deformation. Examples of clinical uses with their associated modes of
loading (e.g. bending, axial, torsion, radial) include the following:
— arterial endovascular prostheses will generally be subject to radial loading;
— non-aortic endovascular prostheses could also be subject to axial, bending and torsion;
— thoracic aortic endovascular prostheses could also be subject to bending.

8.5.2.3.2 Radial fatigue and durability

Evaluate the long-term structural integrity of the endovascular prosthesis when subjected to cyclic
radial loading conditions, if applicable.

8.5.2.3.3 Active fixation fatigue and durability

Evaluate the long-term structural integrity of the securement of the active fixation components (e.g.
barbs, hooks, pins) to the attachment system (e.g. proximal stent) and the securement of the attachment
system to the endovascular prosthesis body when subjected to cyclic loading conditions, if applicable.

8.5.2.3.4 Axial fatigue and durability

Evaluate the long-term structural integrity of the endovascular prosthesis when subjected to cyclic
axial loading conditions, if applicable.

8.5.2.3.5 Bending fatigue and durability

Evaluate the long-term structural integrity of the endovascular prosthesis when subjected to cyclic
bending loading conditions, if applicable.

8.5.2.3.6 Torsional fatigue and durability

Evaluate the long-term structural integrity of the endovascular prosthesis when subjected to cyclic
torsional loading conditions, if applicable.

8.5.2.4 Fixation and seal

Determine the leakage at the seal zone and the separation force for overlapping endovascular
prostheses. Also, evaluate the migration resistance of the endovascular prosthesis.
Additional testing may be appropriate to address potential effects of failure that can be related to
inadequate fixation effectiveness such as radial force, recoil and strength of the connection(s) between

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the graft material and a discrete fixation system(s) which are listed under 8.5.2.5, 8.5.2.7 and 8.5.2.8,
respectively. In addition, testing to address the maintenance of fixation effectiveness is addressed
under 8.5.2.2 and 8.5.2.3.

8.5.2.4.1 Leakage at seal zone

This test applies to a device design modification that may affect the seal zone(s).
Determine the leakage between the seal zone(s) of the endovascular prosthesis and a mock artery and
compare the results to those for the unmodified device. This requirement can alternatively be met
through evaluation of Type I endoleaks in a clinical study.
The evaluation of seal zone leakage is not necessary for endovascular prostheses intended for clinical
uses for which seal zone leakage is unlikely to occur or would not likely be associated with adverse
clinical sequelae (e.g. treatment of occlusive lesions).

8.5.2.4.2 Migration resistance

Evaluate the ability of the endovascular prosthesis to resist migration when subjected to a force or
pressure. The evaluation of migration resistance is not necessary for endovascular prostheses intended
for clinical uses for which migration is unlikely to occur or would not likely be associated with adverse
clinical sequelae (e.g. treatment of occlusive lesions).

8.5.2.4.3 Separation force for overlapping endovascular prostheses

Determine the force required to separate overlapping endovascular prostheses or modular components
(e.g. main body, cuffs, extenders) in the deployed state. The evaluation of separation force is not
necessary for endovascular prostheses intended for clinical uses for which component separation is
unlikely to occur or would not likely be associated with adverse clinical sequelae (e.g. treatment of
occlusive lesions).

8.5.2.5 Patency-related tests

Crush resistance, local compression and radial force characterize different patency-related attributes
of the endovascular prosthesis and are applicable for specific device types and implant locations as
described in Table 1. Resistance to kinking (flexibility) is applicable to all endovascular prostheses.

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Table 1 — Rationale for crush and compression resistance and radial force requirements
Rationale for applicability
Non-aortic implant locations Aortic implant locations
Test Purpose Balloon- Self- Balloon- Self-expanding
expandable expanding expandable endovascular
endovascular endovascular endovascular prostheses
prostheses prostheses prostheses
The purpose of
this test is to
Compression Not applicable Applicable
determine the
resistance to because this because a
force at which Not applicable Not applicable
perpendicularly a pre-specified test does not non-aortic
because the because the
applied load evaluate self-expanding
displacement oc- aorta is not aorta is not
permanent prosthesis
(self- curs under a load typically typically
deformation might be
expanding, applied perpen- subjected to subjected to
relevant to subjected to
non-aortic dicular perpendicularly perpendicularly
balloon- compressive
endovascular to the applied loads. applied loads.
expandable forces that can
prostheses) longitudinal
prostheses. affect patency.
axis of the
prosthesis.
The purpose of
this test is to
determine the
Crush resistance force at which Applicable
with Not applicable
a pre-specified because a Not applicable Not applicable
perpendicularly amount of because self-
non-aortic because the because the
applied load expanding
permanent balloon-ex- aorta is not aorta is not
devices do
(balloon- deformation pandable typically typically
not typically
expandable, occurs under a prosthesis may subjected to subjected to
undergo
non-aortic load applied be permanently perpendicularly perpendicularly
permanent
endovascular perpendicular deformed by an applied loads. applied loads.
deformation.
prostheses) to the external load.
longitudinal
axis of the
prosthesis.
Applicable
The purpose of
because a Applicable be-
Crush resistance this test is to non-aortic
Not applicable
cause an
Not applicable
with radially determine the because self- because self-
balloon- aortic balloon-
applied load radially applied expanding expanding
expandable expandable
load at which a devices do devices do
(balloon- prosthesis prosthesis may
pre-specified not typically not typically
expandable may be be permanently
amount of undergo undergo
endovascular permanently deformed by a
permanent permanent permanent
prostheses) deformed by radially applied
deformation deformation. deformation.
a radially load.
occurs.
applied load.
Not applicable
Not applicable
because Applicable Applicable
The purpose of because balloon-
balloon- because a because an
this test is to expandable
Radial force expandable non-aortic aortic self-
determine the devices can
devices can self-expanding expanding
(self-expanding, outward force exhibit prosthesis
exhibit
prosthesis
endovascular as a function of permanent
permanent exerts a radial exerts a radial
prostheses) the diameter of deformation
deformation outward force outward force
the endovascular which is not
which is not against the against the
prosthesis. evaluated by
evaluated by vessel wall. vessel wall.
this test.
this test.

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8.5.2.5.1 Compression resistance to perpendicularly applied load (self-expanding, non-aortic

endovascular prostheses)

Determine the force at which a pre-specified displacement occurs under a load applied perpendicular
to the longitudinal axis of the prosthesis.

8.5.2.5.2 Crush resistance with perpendicularly applied load (balloon-expandable, non-aortic

endovascular prostheses)

Determine the force at which a pre-specified amount of permanent deformation occurs under a load
applied perpendicular to the longitudinal axis of the prosthesis.

8.5.2.5.3 Crush resistance with radially applied load (balloon-expandable endovascular

prostheses)

Determine the radially applied load at which a pre-specified amount of permanent deformation occurs.

8.5.2.5.4 Radial force (self-expanding endovascular prostheses)

Determine the outward force as a function of the diameter of the endovascular prosthesis.

8.5.2.5.5 Resistance to kinking (flexibility)

Determine the minimum radius that the endovascular prosthesis can accommodate without kinking.

8.5.2.6 Permeability

Determine the porosity, water permeability and/or water entry pressure, as appropriate to the
endovascular prosthesis. The selection of appropriate tests from those listed below shall be justified
based on the graft material of construction. Integral water leakage is applicable to all endovascular
prostheses.

8.5.2.6.1 Integral water leakage

Evaluate the water leakage between modular components and through holes in the graft material
resulting from the construction of the endovascular prosthesis (e.g. holes created by suturing stent
structures to the graft material).

8.5.2.6.2 Porosity (non-textile materials)

Determine the porosity of the graft material for an endovascular prosthesis constructed of non-textile
materials.

8.5.2.6.3 Water entry pressure (non-textile materials)

Determine the pressure required to force water through the graft material of an endovascular
prosthesis constructed of non-textile materials.

8.5.2.6.4 Water permeability (textile materials)

Determine the water flow rate through the graft material of an endovascular prosthesis constructed
with a water-permeable graft material (e.g. woven graft material).

8.5.2.7 Sizing-related testing

Select the appropriate tests from those listed below to aid in the establishment of the sizing
recommendations for the endovascular prosthesis.

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8.5.2.7.1 Dimensional verification of the endovascular prosthesis

Determine the graft material wall thickness(es) and the endovascular prosthesis dimensions in the
deployed state, including the length(s), outer diameter(s) and all other appropriate dimensions, for
verification to design specifications.

8.5.2.7.2 Implant diameter to balloon inflation pressure (balloon-expandable endovascular

prostheses)

Determine the relationship between the prosthesis diameter and the balloon inflation pressure for
balloon-expandable endovascular prostheses.

8.5.2.7.3 Implant length to diameter relationship (endovascular prostheses that have clinically
relevant length changes with diameter changes)

Determine the relationship between the length and diameter for endovascular prostheses that have
clinically relevant length changes with diameter changes.

8.5.2.7.4 Recoil (balloon-expandable endovascular prostheses)

Determine the amount of elastic recoil (percent of diameter reduction), after the deployment of a
balloon-expandable prosthesis. Recoil shall be considered in the sizing recommendations.

8.5.2.8 Strength

Determine the burst strength, factory seam strength, longitudinal tensile strength, strength after
repeated puncture and strength of the connection(s) between the graft material and a discrete fixation
system(s), as appropriate to the endovascular prosthesis. The selection of appropriate tests from those
listed below shall be justified based on the design of the endovascular prosthesis.

8.5.2.8.1 Burst strength

Determine the pressurized burst strength of the graft material or alternatively, the burst strength of
the entire endovascular prosthesis if processing may reduce the strength of the graft material.

8.5.2.8.2 Factory seam strength (endovascular prostheses with seams in the graft material)

Determine the tensile strength of any factory manufactured seams in the graft material. This
requirement is not intended to apply to any connections between stents or between the graft material
and a stent or an attachment system (see 8.5.2.8.5).

8.5.2.8.3 Longitudinal tensile strength

Determine the longitudinal tensile strength of the graft material.

8.5.2.8.4 Strength after repeated puncture (endovascular prostheses for vascular access)

Determine the strength of the endovascular prosthesis following repeated dialysis-needle punctures
for a prosthesis that will be cannulated to provide blood access for haemodialysis.

8.5.2.8.5 Strength of the connection(s) between the graft material and a discrete fixation
system(s)

Determine the strength of the connection(s) between the graft material and the fixation system(s). This
requirement applies to prostheses with a fixation system that is discrete from any stent(s) intended to
provide structural support within the prosthesis (e.g. suprarenal stent that is not continuous with the
stent(s) in the prosthesis body).

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This requirement is to determine the securement of a fixation system (e.g. suprarenal stent) to the
endovascular prosthesis body and not to evaluate the securement of an active fixation component (e.g.
barb, hook, pin) to the fixation system or graft material. As such, the location or presence of an active
fixation component is not relevant for this requirement.
NOTE The structural integrity of the securement of an active fixation component (e.g. barb, hook, pin) to the
fixation system is addressed in 8.5.2.3.3.

8.5.2.9 Magnetic resonance imaging (MRI) safety

Using clinically relevant MR environments (e.g. appropriate static magnetic field and spatial magnetic
gradient field), evaluate the potential for magnetically induced displacement force and torque and
RF induced heating of the prosthesis. Determine the appropriate MR safety term (i.e. MR safe, MR
conditional or MR unsafe) as defined in ASTM F2503.
Characterize the MR image artefact produced by the prosthesis. Describe the location and extent of the
image artefact effect on the ability to visualize the device and adjacent anatomy.
NOTE No acceptance criterion is needed for image artefact as the effect of the MR artefact on the usefulness
of the image depends on the MR environment and the anatomical region being imaged with respect to the location
of the prosthesis. For example, although image artefact associated with an abdominal prosthesis can affect the
ability to image the lumbar spine, it would not affect the ability to image the head and neck.

Test methods for evaluating magnetically induced displacement, torque, RF heating and imaging
artefact can be found in
— ASTM F2052,
— ASTM F2213,
— ASTM F2182, and
— ASTM F2119.

8.6 Preclinical in vivo evaluation

8.6.1 Purpose

The purpose of preclinical in vivo testing is to evaluate the deployment of the endovascular prosthesis,
the biological response of the host to the prosthesis and the effect of the implant environment on the
prosthesis. If the objective of an animal study can be met through alternative means (e.g. through
reference to previously conducted animal and/or clinical studies), the use of previously obtained data
or other supportive information shall be justified. The justification should include comment on the
relevance of any differences between the subject device and the device used in the previous study and
the relevance of any differences in the intended uses.
The principles of 8.6 may be applied for the preclinical in vivo evaluation of particular configurations of
prostheses (e.g. fenestrated, branched) and vascular uses other than the treatment of arterial stenoses
and aneurysms. Additional specific aims, endpoints and reporting requirements might be needed to
define an appropriate study.

8.6.2 Specific aims

Specific aims of the study shall be stated in the protocol. More than one study may be used to address
these aims, which can include the following:
a) evaluate the ability to access the target location with the delivery system.
b) evaluate the handling, ease of use and visualization of the delivery system, and visualization of the
endovascular prosthesis;

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c) evaluate the accuracy of deployment;

d) evaluate the compatibility of accessory devices with the endovascular system, including balloons
used post-deployment;
e) evaluate the ability to withdraw the delivery system;
f) evaluate the functional haemostasis of the delivery system and sheath introducer;
g) evaluate the position, structural and material integrity and patency of the endovascular prosthesis
acutely and at explant;
h) evaluate histology and pathology of explants and pertinent tissues/organs;
i) record failure modes, device and clinical effects of failure (see Annex B for potential failure modes
and effects of failure) and adverse events.

8.6.3 Protocol considerations

Each type of prosthesis shall be tested by implantation at the intended, or an analogous, vascular site
in a reasonable number of animals for an adequate duration of time to accomplish the specific aims of
the study. A control might be appropriate for comparison purposes. The type and intervals of interim
assessments shall be specified and justified. As far as permitted by the limitations of the animal model,
all devices used should be of clinical quality and size and of the design intended for clinical use.
All animals in the study shall be regularly examined. Histological and pathological assessment of
explants and appropriate tissues/organs shall be completed. If an animal either dies or must be
sacrificed prior to scheduled termination, it shall be subjected to immediate post-mortem examination.
The cause of death or illness, and the extent to which the implant was implicated, shall be documented.
Information for all animals implanted with either test or control prostheses, including those excluded
from the final analyses, shall be recorded and included in the test report.
The design of the preclinical in vivo testing, including the experimental protocol, measurement methods
and data analysis, shall be documented. In addition, the choice of animal model, such as species, sex,
age, and whether or not a lesion is created, shall be justified and shall be consistent with the study
objectives. Implantation shall be consistent with the recommended deployment instructions as far as
permitted by the limitations of the animal model.
Appropriate quality management practices and animal welfare protection measures should be followed
in the execution of an animal study.

8.6.4 Data acquisition

The following minimum data shall be recorded for each animal receiving prosthesis:
a) identification data:
1) source of animal;
2) animal identification;
3) sex;
4) approximate age;
5) mass;
b) pre-operative data:
1) verification of satisfactory health status;

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2) medication (e.g. prophylactic antibiotics);

c) operative data:
1) date of procedure;
2) name of person(s) performing procedure;
3) prosthesis identification;
4) in situ length of prosthesis;
5) target vessel and prosthesis diameters;
6) location and length of overlap for overlapping devices;
7) use of systemic antiplatelet/anticoagulant therapy;
8) assessment of the ability to access the target vessel location (e.g. pushability, flexibility,
torquability, trackability);
9) assessment of the ease and ability to accurately deploy the prosthesis;
10) assessment of the ability to visualize the delivery system and the implant;
11) assessment of the ability to withdraw the delivery system;
12) assessment of the compatibility with accessory devices (e.g. balloons used during or after
deployment);
13) assessment of blood loss (e.g. amount and location);
14) assessment of position, conformability, patency and absence of abnormalities (e.g. kinks,
twists, component separation, non-uniform expansion and prosthesis damage) of the implant;
15) observed device and clinical effects of failure and adverse perioperative events, including
severity, management and outcome;
16) any significant deviation from the proposed deployment instructions or protocol;
d) post-operative and follow-up data:
1) medications, including those that affect coagulation;
2) assessment of structural integrity, patency and position of the prosthesis, including the method
and date of visualization;
3) observed device and clinical effects of failure and adverse events, including date of occurrence,
severity, management and outcome;
4) any significant deviation from the protocol;
e) termination data:
1) date of sacrifice;
2) name of person(s) performing procedures and assessments;
3) assessment of structural integrity, patency and position of prosthesis, including method of
visualization;
4) gross alteration in the dimensional and physical properties of the prosthesis;
5) histological and pathological assessment of explants and appropriate surrounding and distal
tissues/organs.

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8.6.5 Test report and additional information

Results of all animals enrolled in the protocol shall be recorded and reported, even if excluded from the
final analysis.
The test report shall include the following:
a) study protocol;
b) rationale for selection of the following:
1) animal model;
2) implantation site;
3) control for comparison, if applicable;
4) implantation periods;
5) methods of assessment;
6) intervals of observation;
7) sample size (i.e. number of animals and implants);
c) summary of results:
1) animal accountability, including rationale for exclusion of data from the primary analysis;
2) number of animals for which there was successful implantation of the prosthesis;
3) operator assessment of ease of deployment, visualization and handling;
4) discussion of appropriateness of sizing and potential impact on study results;
5) summary of any changes in position, structural and material integrity and patency of the
prosthesis;
6) summary of device and clinical effects of failure and adverse events;
7) summary of early deaths or sacrifices for cause;
8) significant and/or relevant deviations from protocol;
9) summary of pathology and histology of explants and appropriate tissues/organs, including
representative gross photographs and micrographs;
10) comparison of outcomes for test and control groups, if applicable;
11) conclusions from study;
12) summary of quality assurance and data auditing procedures.

8.7 Clinical evaluation

8.7.1 Purpose

The purpose of clinical evaluation is to assess the safety and effectiveness of an endovascular system.
This evaluation is not intended to demonstrate the long-term performance of the prosthesis. An
investigation should be carried out for each new prosthesis or new clinical application of a prosthesis
using the principles given in ISO 14155, or an equivalent publication. Significant design changes that
can impact safety and performance shall require clinical evaluation if determined to be necessary

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based on an appropriate risk assessment. Additional prosthesis sizes outside the previously evaluated
range might require clinical evaluation.
If an objective of a clinical study can be met through alternative means (e.g. through reference to
previously conducted clinical studies), the use of previously obtained data or other supportive
information shall be justified. The justification should include comment on the relevance of any
differences between the subject device and the device used in the previous study and the relevance of
any differences in the intended uses.
The principles of 8.7 may be applied for the clinical evaluation of particular configurations of prostheses
(e.g. fenestrated, branched) and vascular uses other than the treatment of arterial stenoses and
aneurysms. Additional specific aims, endpoints, and reporting requirements might be needed to define
an appropriate study.

8.7.2 Specific aims

Specific aims of the study shall be based on an appropriate risk assessment for the endovascular system
and stated in the protocol. The specific aims may include the following:
a) evaluate the effectiveness of the endovascular system, such as the following:
1) ability to access the target location with the delivery system;
2) accuracy of deployment;
3) ability to withdraw the delivery system;
4) position, structural and material integrity and functionality of the prosthesis acutely and
over time;
5) lesion characteristics (e.g. aneurysm size, restenosis, false lumen perfusion) over time;
6) device effects of failure (see Annex B for potential effects of failure);
b) evaluate the safety of the endovascular system, such as the following:
1) clinical effects of failure (see Annex B for potential clinical effects of failure);
2) adverse events.

8.7.3 Protocol considerations

A multicentre study shall be performed at a minimum of three investigational sites. A justification for
the number of investigational sites shall be provided.
A specific question or set of questions (i.e. hypotheses) shall be defined prospectively. These questions
shall delineate the appropriate safety (e.g. freedom from major adverse events), effectiveness (e.g.
technical success in absence of serious device related events) or combined safety and effectiveness
endpoints (e.g. 30-day mortality for the treatment of dissections) to be measured. Definitions of success
and failure for each endpoint and the duration of follow-up needed to assess each endpoint shall be
specified. A definition for the study success shall also be specified (e.g. meeting both the safety and
effectiveness primary endpoints).
A statistical justification for the number of patients studied shall be provided based upon the primary
hypotheses. No investigational site should enrol more that 35 % of the total number of study subjects.
The clinical investigation shall be continued for a minimum of 12 mos for each patient unless a
justification for a different study duration is provided. Patient follow-up intervals shall include a
minimum of a baseline assessment at discharge and an assessment at the specified study duration. A
justification will be required for follow-up intervals. All patients enrolled in the study, including those
excluded from the primary endpoint analyses, shall be recorded and reported. The final report may be

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completed when the required number of patients to test the hypotheses has reached the specified study
duration. The report shall include current follow-up data on all patients. Longer-term patient follow-up
(e.g. 3 years to 5 years after the last prosthesis has been implanted) may be appropriate for the post-
market clinical assessment of device designs with a limited history of clinical use.
A control should be included in the study to appropriately address the questions postulated. If an
appropriate control is not or cannot be identified, or a concurrent control is unnecessary, a method for
evaluating the clinical outcomes shall be prospectively defined and justified (e.g. performance goals).
The study design shall be designated by the following terms:
— randomized, multi-arm, “unblinded” study with a concurrent control using an alternative or no
treatment;
— non-randomized study with concurrent control;
— single-arm study with patient serving as own control (include designed single-arm crossover);
— single-arm study with historical control using patient-level data;
— single-arm study with literature control;
— single-arm study with performance goals.
The protocol may differ between the control group and the treatment group. If so, a separate protocol
for the assessment of the control subjects shall be included.
Patient inclusion and exclusion criteria shall be clearly identified. The criteria shall specify the target
population (i.e. those for whom the implant is intended) and the accessible population (i.e. those who
agree and are able to participate fully in the study). An appropriate epidemiological approach shall be
utilized for recruiting subjects to minimize bias (e.g. encourage sequential enrolment).
Definitions, primary and secondary clinical endpoints, measurement methods and data analysis shall
be specified in the clinical protocol. Secondary endpoints might include the following:
— individual components that make up any composite primary endpoints;
— technical success [e.g. successful placement of all endovascular graft components at the intended
implantation site(s) with patency and an absence of significant device deformations, e.g. kinks, stent
eversion, twists];
— procedural success (e.g. technical success in absence of serious device-related adverse events at 30 d);
— device and clinical effects of failure;
— secondary endovascular procedures;
— conversions to open surgical repair;
— indication-related mortality (e.g. aneurysm-related mortality);
— longer-term outcomes (e.g. 12-month safety data if the primary safety endpoint is at 30 d).

8.7.4 Data acquisition

At a minimum, the following data shall be recorded for each patient in the study:
a) identification and demographic data:
1) patient identification;
2) indication for treatment (e.g. malperfusion, rapidly expanding aneurysm, critical limb
ischaemia) and associated medical diagnosis (e.g. aneurysm, dissection, occlusion, transection);

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ISO 25539-1:2017(E)


3) demographics:
i) date of birth;
ii) sex;
iii) weight;
iv) height;
v) race, as appropriate (i.e. when this information can be legally obtained);
4) name of investigator;
5) name of institution;
b) pre-operative data:
1) risk factors, such as hypertension, diabetes, coronary artery disease, hyperlipidemia, tobacco
use, obesity, anaesthesia risk and any other cardiovascular risk factors;
2) summary of previous vascular interventions at the same or other relevant vascular sites and
adjunctive vascular interventions (e.g. carotid-subclavian bypass, aortic vessel debranching),
including non-surgical interventions and previously implanted vascular devices (e.g. stents,
endovascular prostheses, surgically placed vascular prostheses);
3) relevant medications;
4) diagnostic criteria:
i) clinical assessment;
ii) objective assessment of lesion and access vessel characteristics and other relevant factors
(e.g. sizes, neck lengths, extent of dissection, location of primary entry tear, tortuosity,
angle of seal zones);
c) operative data:
1) name of implanting physician;
2) date of procedure;
3) identification data for the endovascular prosthesis(es) including model number, implant
traceability, size and configuration;
4) urgency of intervention (i.e. urgent, emergent or elective);
5) information regarding the procedure (e.g. adjunctive vascular procedures performed, type of
anaesthesia, total fluoroscopy time, coverage of main branch vessels);
6) relevant medications (e.g. heparin, other anticoagulants);
7) assessment of technical success;
8) position of prosthesis (e.g. neck length covered by prosthesis for treatment of aneurysms,
distance from anatomical landmarks);
9) assessment of prosthesis effectiveness (e.g. endoleaks, including type, location, need for
intervention; residual stenosis; patency);
10) plan for additional procedures to complete the repair (e.g. staged procedure);
For staged procedures, consistent information should be captured for each intervention at the time
of each procedure.

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11) record device and clinical effects of failure and adverse events [see item e)];
12) date of hospital discharge;
d) follow-up:
1) interval of follow-up (e.g. discharge, 30 d, 12 mos);
2) date of follow-up visit;
3) clinical and imaging evaluation:
i) clinical assessment;
ii) objective assessment of prosthesis positioning, integrity and effectiveness and method of
assessment;
iii) objective assessment of targeted lesion characteristics (e.g. aneurysm size, false lumen
thrombosis, patency, branch vessel patency, percentage of diameter stenosis) and method
of assessment;
4) relevant medications, such as anticoagulants or antiplatelets;
5) record device and clinical effects of failure and adverse events [see item e)];
e) device and clinical effects of failure, and adverse events:
1) type of effect or event, date of occurrence, severity, management (e.g. none, medical treatment,
secondary endovascular procedure, open surgical procedure), outcome (e.g. continuing,
resolved, unknown, death);
2) documentation of prosthesis involvement;
3) documentation of probable causative factors (e.g. caused by the prosthesis, patient factors,
technical factors);
f) secondary procedures associated with the index procedure:
1) date;
2) reason for intervention;
3) type of intervention;
4) outcome of intervention;
g) death:
1) date;
2) whether autopsy was performed, and if so, the findings;
3) cause of death;
4) whether or not the death was related to the prosthesis or procedure;
h) explant of prosthesis:
1) date;
2) whether the subject is living or deceased;
3) reason for explant;
4) associated device effects of failure, if applicable;

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ISO 25539-1:2017(E)


5) relevant observations (e.g. device integrity, device positioning, tissue incorporation, vascular
tissue erosion);
i) patient withdrawal:
1) date;
2) months of study completed;
3) reason for withdrawal (e.g. lost to follow-up, withdrew consent, removed from study per
physician recommendation).

8.7.5 Final report

The clinical report shall include the following:

a) study protocol, including at a minimum:
1) study description (e.g. study design designation, control arm, number of sites, number of
patients);
2) primary and secondary endpoints, hypotheses and definitions of success;
3) definition of study success;
4) subject population (i.e. selection criteria);
5) follow-up intervals;
6) methods of assessment [e.g. clinical, computed tomography angiography (CTA), magnetic
resonance angiography (MRA), duplex ultrasound];
7) data analysis plan;
8) definitions of technical and procedural success, device and clinical effects of failure and
adverse events;
b) rationale, based on the risk assessment and questions to be answered, for selection of the following:
1) study size;
2) choice of control;
3) measurement methods;
4) statistical analyses employed;
5) patient follow-up intervals;
c) number of patients treated at each investigational site;
d) follow-up accountability (e.g. numbers of patients eligible for each follow-up interval and the
number with specified follow-up data), including a rationale for the exclusion of data from the
primary endpoint analyses;
e) demographics, risk factors and relevant vascular lesion characteristics (e.g. sizes of aneurysm
treated, lengths of the stenotic lesions);
f) numbers of devices per patient and sizes of devices used;
g) significant and/or relevant deviations from protocol;

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h) results:
1) technical success;
2) procedural success;
3) safety:
i) primary and secondary endpoint outcomes;
ii) summary of peri-procedural (less than or equal to 30 days, or prior to hospital discharge)
and late conversions to open surgery;
iii) summary of peri-procedural and late deaths;
4) effectiveness:
i) primary and secondary endpoint outcomes;
ii) summary of secondary interventions;
5) summary of explant analyses;
6) conclusions from study, including results of hypothesis testing and achievement of success as
defined by the protocol.

9 Post-market surveillance
A systematic procedure to review post-market experience gained from implants shall be in place using
the principles given in ISO 14630:2012, 7.4 and ISO 14971, or equivalent publications.

10 Manufacturing
Endovascular systems shall be manufactured in such a way that the design attributes are achieved.
Requirements are specified in other related International Standards.
The requirements of ISO 13485 and ISO 14630:2012, Clause 8 apply.

11 Sterilization

11.1 Products supplied sterile

Endovascular systems shall be labelled “Sterile”, comply with national or regional standards and
have a sterility assurance level (SAL) of 10−6. Sterilization processes shall be validated and routinely
controlled.
a) For endovascular systems that are to be sterilized by ethylene oxide, ISO 11135 applies.
b) For endovascular systems that are to be sterilized by radiation, ISO 11137 (all parts) applies.
c) For single-use endovascular systems incorporating animal tissue that are to be sterilized using
liquid chemical sterilants, ISO 14160 applies.
d) For endovascular systems that are to be sterilized by other sterilization processes, ISO 14937
applies.

11.2 Sterilization residuals

The requirements of ISO 14630:2012, 9.4 shall apply.

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12 Packaging

12.1 Protection from damage in storage and transport

12.1.1 General

The requirements of ISO 14630:2012, Clause 10 shall apply.

12.1.2 Unit container

Each endovascular system shall be packaged in a unit container providing a sterile barrier. It shall be
readily apparent if the unit container has been opened.

12.1.3 Outer container

Each unit container shall be packaged in an outer container. This outer container shall be designed so as
to protect the unit container from damage due to storage.

12.1.4 Shipping container

Each outer container, or a number of outer containers not necessarily of the same type, may be packaged
in a shipping container designed to protect the contents under normal conditions of handling, transit
and storage.

12.1.5 Maintenance of sterility in transit

The unit container shall be designed to maintain the sterility of the endovascular system under nominal
conditions of handling, transit and storage, and to permit the contents to be presented for use in an
aseptic manner.
The packaging shall conform to ISO 11607-1.

12.2 Labelling

12.2.1 Container label

Each endovascular system shall be accompanied by a label(s) on an appropriate container(s). At least

the following information shall be provided on the label(s):
a) name, address and/or trademark of the manufacturer;
b) product name;
c) the material of construction and type of construction;
d) the configuration (see 4.3). A symbol may be substituted for a written description of the prosthesis;
e) the nominal length(s);
f) the nominal diameter(s);
g) the words “STERILE — DO NOT RESTERILIZE — SINGLE USE ONLY”, or equivalent phrase or
symbols, in prominent form;
h) method of sterilization;
i) sterile lot number;
j) date of sterilization and/or the expiry/expiration date;

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k) manufacturer’s batch or lot number;

l) a warning against the use of the endovascular system if the package is open or damaged;
m) manufacturer’s recommendations for storage, when applicable.
NOTE If the manufacturer’s batch or lot number [see item k)] and the sterile lot number [see item i)] can be
traced to the same information, only one number needs to be given.

12.2.2 Record label

Each endovascular system should be supplied with transferable record labels suitable for attachment
to the records of the patient receiving the prosthesis. The record label shall include the following
information:
a) manufacturer’s identification;
b) product name;
c) manufacturer’s batch and/or sterile lot number;
d) part or model number (manufacturer’s catalogue number).

12.3 Instructions for use

12.3.1 General

The requirements of ISO 14630:2012, 11.3 shall apply.

12.3.2 Information and instructions for use for endovascular systems

Each unit container or outer container of which the contents are identical shall be supplied with
instructions for the use (IFU) of the endovascular system or instructions on how to access an electronic
version of the IFU. The instructions shall include the following information to use the endovascular
prosthesis safely and properly, taking into account the training and knowledge of the potential users:
a) name, address and/or trademark of the manufacturer;
b) product name;
c) device description and materials of construction;
d) indications for use;
e) contraindications, cautions and warnings;
f) potential adverse events;
g) data from clinical studies, if applicable;
h) recommendations for endovascular prosthesis sizing;
i) recommended methods for the preparation of the endovascular system and implantation
techniques;
j) the statement “STERILE — DO NOT RESTERILIZE — SINGLE USE ONLY” in prominent form;
k) notification of additives and/or leachable components, if applicable;
l) recommendations for storage, if applicable;
m) recommendations for visualization;

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n) MRI safety information;

o) revision date.

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Annex A
(informative)

Relationship between testing requirements and device attributes

and potential failure modes

A.1 General
Tables A.3 and A.4 provide the rationale for the requirements specified in this document for bench tests
and analyses to assess device performance. The table headings are described in Table A.1. Clause A.2
also provides guidance on the identification of appropriate testing to evaluate a specific device design.
Clause A.3, with Tables A.5 to A.7, provides guidance on the identification of appropriate testing to
evaluate design modifications and changes in intended use.
Annex B provides a description of the potential effects of failure identified in Annex A.
Annex C provides a list of the bench tests and analyses, with a description of the purpose of each test,
the associated device-related and procedure-related functions identified in Annex A, and reference to
applicable design evaluation sections in this document (Clause 8) and the applicable test methods in
Annex D.
Annex D provides information to consider in developing appropriate bench test and analytical methods.

A.2 Identification of appropriate testing

A device evaluation strategy (DES) provides the rationale for the evaluation plan for a specific device
design. Identification of the appropriate testing involves describing each device-related and procedure-
related function needed to achieve the desired performance, the associated device design features, the
potential specific failure modes if the function is not attained, how the failures could affect the device
and patients (i.e. the effects of failure) and finally, the testing needed to assess the device attribute or
failure mode. A DES table may have column headings as presented and explained in Table A.1. The most
critical functions and failure modes that represent the highest risk to patients should be highlighted in
the DES table to provide perspective on the appropriate level of mitigation activities.
Tables A.3 and A.4 provide the rationale for the requirements specified in this document, including
basic information that is applicable to most endovascular prostheses. The device design column is not
included in Tables A.3 and A.4 because these tables provide general information and not design-specific
information.
The columns for a device-specific DES are outlined in Table A.1, however, additional columns may be
added. The information provided in Tables A.3 and A.4 may be of use in populating a device-specific
DES table with these column headers. These tables may be modified to remove information that is
not applicable for the device being evaluated and to add information specific to the unique design or
intended use of the device. For example, rows that address balloon testing should be removed if there is
no balloon used in the delivery of the device. It may be appropriate to include subcategories of potential
device effects of failure applicable to the device design (e.g. subcategories for “delivery system damage”
to identify the potential types of damage to specific components of the delivery system). The nonclinical
testing column may include bench tests, analyses and information on preclinical in vivo evaluations of
the device as related to the evaluation of a particular function or potential failure mode.
Regarding potential device effects of failure, further categorization is included in Tables A.3 and A.4
to acknowledge that one effect might lead to a subsequent effect of failure. For example, attachment
system disconnection might lead to migration. For this example, attachment system disconnection

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would be listed under “device effects of failure” and migration would be listed under “subsequent
device effects of failure”.
Regarding potential clinical effects of failure, commonly listed groups of clinical effects have been
assigned abbreviations as described in Table A.2. These abbreviations are used throughout this
document to minimize redundancy. “A non-specific clinical event or use of additional devices or
procedures”, designated as ACE4 in Table A.2, is applicable for all potential failure modes, but is not
repeated to decrease redundancy. Although they are known potential clinical effects, “Death” and
“Surgical Conversion” are not listed in the tables because conversion and death are correlated to the
severity of the failure and not helpful in identifying tests to evaluate device function.
To reduce redundancy, some potential failure modes associated with individual device and procedure
related functions are not repeated if covered under previously identified functions (e.g. deployment
related failure modes that may affect patency are listed under the device function “ability to deploy”
and not repeated under “patency”).

Table A.1 — Table headings and explanations for Tables A.3 and A.4 and for a device-specific DESa
Device design Potential effect(s) of failure
information Nonclinical
Device/Procedure Potential failure Device effect(s) of failure Clinical
(applicable for effect(s) device
related function(s) mode(s)
a device-specific Subsequent of testingb
Initial effect(s)
DES table)a effect(s) failure
The key design
feature
characteristics
intended to
provide the
function or to
address or
mitigate the The specific
potential failures that
failure mode. might occur and
could result in
Optional: consequences The potential
Each individual provide relevant (effects) to the effect(s) of the
device-related and information about device or failure mode on
procedure-related design of the patient if the the device.
function required device (i.e. design function is not
for the device to input) that will aid attained. Device effects of The potential Bench tests
failure describe The
achieve the overall in understanding additional and analyses
NOTE Individual what happens potential
desired the testing selected device effect(s), of the device
failure modes to the device as effect(s)
performance. to address the if any, resulting to evaluate
should be a result of the of the
attribute or from one of the the function
NOTE Functions addressed failure and may failure mode
potential failure effects listed in and the
should be attributes separately. They be important to on the
mode. the previous potential
of the device or should be capture, patient.
column. failure mode.
procedure and An example of presented in whether or not
therefore, should relevant separate rows there is an
be stated in the information would for an attribute, associated
positive. be the as they may have clinical effect
incorporation of different effects of failure.
the design of failure and
characteristic of may be mitigated
controlled release with different
of the proximal testing.
attachment system
to avoid improper
positioning,
configuration, or
orientation, as this
has been successful
in other devices.
a The device design column should be included in a device-specific DES table. This column is not included in Tables A.3 and A.4 because these tables
provide general information and not design-specific information.
b This column may also include information on any preclinical in vivo evaluations used to evaluate a particular function or failure mode for a device-
specific DES table.

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Table A.2 — Legend for grouped associated clinical effects of failure

ACE1 ACE2 ACE3 ACE4
Migration Prosthesis component Loss of patency Non-specific consequences
separation
— Aneurysm enlargement — Aneurysm enlargement — Amputation A non-specific clinical event
or use of additional devices
— Aneurysm rupture — Aneurysm rupture — Ischaemia
or procedures
— Aortic enlargement — Branch vessel loss of — Lumen obstruc-
patency tion
— Branch vessel loss of
patency — Ischaemia — Prosthesis
occlusion
— False lumen patency — Lumen obstruction
— Restenosis
— False lumen perfusion — Type IIIa endoleak
— Thrombosis
— Ischaemia
— Lumen obstruction
— Type I endoleak

Table A.3 — Device evaluation strategy for the endovascular system

Potential effect(s) of failure
Device/Procedure Potential failure Device effect(s) of failure Clinical Nonclinical
related function(s) mode(s) effect(s) of device testing
Subsequent
Initial effect(s) failure
effect(s)
Ability to access Endovascular — Access failure None — Access vessel — Dimensional
system is injury verification
incompatible with — Accessory
accessory devices device failure — Failure to — Simulated use
complete device
— Delivery system implantation
damage
— Prosthesis damage
Inability to — Access failure None — Access vessel — Simulated use
advance injury
endovascular — Delivery system — Torsional bond
system to damage — Access vessel strength
target site rupture
— Prosthesis damage
— Failure to
complete device
implantation
— Vascular injury–
Delivery system
related
Prosthesis dis- — Prosthesis None — Failure to — Dislodgement force
lodgement from the dislodgement complete device
delivery system from the delivery implantation — Simulated use
system
— Foreign body
embolization
— Ischaemia
Ability to deploy Inability to — Balloon-related None — Failure to — Force to deploy
activate deployment failure complete device
deployment mecha- implantation — Simulated use
nism or procedure — Deployment sys-
tem failure
— Inability to deploy

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ISO 25539-1:2017(E)


Table A.3 (continued)

Potential effect(s) of failure
Device/Procedure Potential failure Device effect(s) of failure Clinical Nonclinical
related function(s) mode(s) effect(s) of device testing
Subsequent
Initial effect(s) failure
effect(s)
Improper position- — Inaccurate None ACE3 — Implant length to
ing, configuration, deployment diameter relationship
or orientation — Aneurysm
— Lack of enlargement — Simulated use
conformance to
the vessel wall — Aneurysm
(e.g. bird beaking) rupture

— Maldeployment — Aortic
enlargement
— Misaligned
deployment — Branch vessel
blockage
— Branch vessel
coverage
— Dissection
creation or
extension
— False lumen
patency
— False lumen
perfusion
— Type I endoleak
— Vascular injury
– endovascular pros-
thesis related
Excessive — Balloon rupture None — Branch vessel — Balloon pressure for
balloon thrombosis non-compliant balloons
inflation
— Dissection — Balloon volume to
creation or burst for compliant
extension balloons
— Foreign body
embolization
(balloon
fragments)
— Restenosis
— Thrombosis
— Vascular injury–
Delivery system
— Vessel rupture
Ability to withdraw Incomplete — Prosthesis — Migration ACE1 — Balloon deflation
balloon dislodgement time
deflation — Access vessel
injury — Simulated use
— Access vessel
rupture
— Vascular injury
– delivery system
related
Damage of — Prosthesis damage — Migration — ACE1 — Dimensional
implant verification
components — Prosthesis — Foreign body
by other dislodgement embolization — Simulated use
components
(e.g. delivery
system
snagging on
the prosthesis)

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Table A.3 (continued)

Potential effect(s) of failure
Device/Procedure Potential failure Device effect(s) of failure Clinical Nonclinical
related function(s) mode(s) effect(s) of device testing
Subsequent
Initial effect(s) failure
effect(s)
Atraumatic Emboli generation None None — Embolism — None
introduction,
tracking and — Ischaemia
withdrawal Particulate None None — Adverse — Simulated use
generation biological
response
— Ischaemia
Trauma to None None — Access vessel — Dimensional
vasculature injury verification
— Access vessel — Simulated use
rupture
— Unintentional
dissection septum
perforation
— Vascular injury–
Delivery system
related
Delivery system Separation of de- — Delivery system — Deployment — Failure to — Simulated use
integrity livery system com- damage system failure complete device
ponents (e.g. bond implantation — Tensile bond
failures, complete strength
tip separation) — Foreign body
embolization — Torsional bond
strength
— Vascular injury
– delivery system
related
Tubing material — Delivery system — Deployment — Failure to — Simulated use
failure damage system failure complete device
implantation — Tensile bond
strength
— Foreign body
embolization — Torsional bond
strength
— Vascular injury–
Delivery system
related
Loss of balloon — Balloon-related None — Failure to — Balloon rated fatigue
integrity deployment failure complete device
implantation — Balloon burst
— Balloon rupture pressure for
— Foreign body non-compliant
embolization balloons
— Balloon volume
to burst for
compliant balloons
Other loss of — Delivery system — Deployment — Failure to — As appropriate to the
delivery system damage system failure complete device design of the device
integrity implantation
Haemostasis Inadequate None None — Blood loss — Dimensional
haemostasis verification
— Haemostasis
Sterility Non-sterile product None None — Insertion site — Sterilization assur-
infection ance
— Prosthesis infec-
tion

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ISO 25539-1:2017(E)


Table A.3 (continued)

Potential effect(s) of failure
Device/Procedure Potential failure Device effect(s) of failure Clinical Nonclinical
related function(s) mode(s) effect(s) of device testing
Subsequent
Initial effect(s) failure
effect(s)
Biocompatibility Non- None None — Adverse — Biocompatibility
biocompatible biological
response
Visualization Inability to safely — All device effects None — All clinical effects — Visibility
and effectively associated with ac- of failure associated
access, deploy, or cess, deployment and with inability to
withdraw withdrawal access, deploy, or
withdraw
None None — Inability to mon-
Inadequate visibili- itor the
ty of the prosthesis prosthesis
over time

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Table A.4 — Device evaluation strategy for endovascular prosthesis

Potential effect(s) of failure
Potential
Device/Procedure Device effect(s) of failure Clinical Nonclinical
failure
related function(s) effect(s) of device testing
mode(s) Subsequent
Initial effect(s) failure
effect(s)
Fixation Excessive radial None None — Dissection — Radial force (self-ex-
effectiveness force creation or panding)
extension
— Erosion leading to
fistula formation
— Vascular
injury–
endovascular
prosthesis related
Inadequate — Migration None ACE1 — Migration
fixation resistance
— Prosthesis ACE2
component — Radial force
separation (self-expanding)
— Recoil
(balloon-
expandable)
— Separation
force for
overlapping
prostheses
— Strength of
the connection(s)
between the graft
material and a
discrete fixation
system(s)
Prosthesis integrity Structural — Delamination — Graft — Aneurysm en- — Fatigue and
failure of dilatation or largement durability
graft material rupture
(includes loss of — Aneurysm rupture
integrity due to — Aortic
any cause, such enlargement
as wear
between — Type IIIb
modular endoleak
components)
— Graft dilatation None — Aneurysm en- — Burst strength
or rupture largement
— Longitudinal tensile
— Aneurysm rupture strength
— Aortic
enlargement
— Graft material None — Type IIIb — Fatigue and
holes endoleak durability

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Table A.4 (continued)

Potential effect(s) of failure
Potential
Device/Procedure Device effect(s) of failure Clinical Nonclinical
failure
related function(s) effect(s) of device testing
mode(s) Subsequent
Initial effect(s) failure
effect(s)
Structural failure of — Active fixation — Lack of ACE1 — Active fixation
mechanical support element (hook/barb) conformance fatigue and
structures or fracture to the vessel durability
fixation wall
systems — Computational
(includes loss — Migration analyses
of integrity due — Support structure — Graft ACE1 — Computational
to any cause, fracture material holes analyses
such as wear ACE2
between — Lack of — Fatigue and
conformance to — Foreign body durability
modular
the vessel wall embolization
components,
— Simulated use
fatigue) — Type IIIb
— Migration
endoleak
— Prosthesis
component sepa- — Vascular injury
ration – endovascular
prosthesis related
— Metallic bond — Attachment ACE 1 — Computational
fracture system analyses
disconnection — Foreign body
embolization — Fatigue and
— Graft durability
material holes — Type IIIb
endoleak — Simulated use
— Migration
— Strength of the
— Support struc- connection(s) or
ture separation bond(s) between the
graft material and the
stent(s) or
attachment
system(s)

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Table A.4 (continued)

Potential effect(s) of failure
Potential
Device/Procedure Device effect(s) of failure Clinical Nonclinical
failure
related function(s) effect(s) of device testing
mode(s) Subsequent
Initial effect(s) failure
effect(s)
Loss of — Attachment — Migration ACE1 — Computational
attachment system analyses
between parts disconnection
of the — Fatigue and
endovascular durability
prosthesis (e.g. — Simulated use
between graft
material and — Strength of the
mechanical connection(s) or
support bond(s) between
structure, the graft material
between stent and the stent(s)
rings) or attachment
system(s)
— Separation of — Graft — Type IIIb — Fatigue and
covering from material holes endoleak durability
stent
— Simulated use
— Strength of the
connection(s) or
bond(s) between
the graft material
and the stent(s)
or attachment
system(s)
— Suture breaks — Attachment ACE1 — Factory seam
system strength
— Graft material tear disconnection — Type IIIb
at seams endoleak — Fatigue and
— Graft durability
material holes
— Simulated use
— Migration
— Strength of the
— Support connection(s) or
structure bond(s) between
separation the graft material
and the stent(s)
or attachment
system(s)
— Leakage at None — Aneurysm — Integral water
factory seam enlargement leakage
— Aneurysm
rupture
— Aortic
enlargement
— Aortic
rupture
— Type IIIb
endoleak
Structural — Delamination None — Blood loss — Strength after
failure of graft repeated puncture for
material after — Graft dilatation or vascular access
repeated rupture
puncture for
vascular
access grafts

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Table A.4 (continued)

Potential effect(s) of failure
Potential
Device/Procedure Device effect(s) of failure Clinical Nonclinical
failure
related function(s) effect(s) of device testing
mode(s) Subsequent
Initial effect(s) failure
effect(s)
Corrosion — Active fixation — Lack of ACE1 — Corrosion
element (hook/barb) conformance
fracture to the vessel ACE2
wall — Adverse
— Metallic bond
fracture — Prosthesis biological
component sepa- response
— Support structure ration
fracture — Foreign body
— Migration embolization
— Vascular
injury–
endovascular
prosthesis
related
Adequate Seal Inadequate — Lack of None — False lumen — Leakage at seal zone
exclusion of conformance to patency
the lesion the vessel wall — Simulated use
(e.g. bird beaking) — False lumen
perfusion
— Type I
endoleak
Appropriate Inadequate None None ACE1 — Porosity, water
permeability biological permeability,
incorporation — Prosthesis infec- integral water
due to tion leakage and water
insufficient — Thrombosis entry pressure, as
permeability appropriate
Excessive — Leaking through None — Aneurysm en- — Porosity, water
permeability graft material largement permeability,
or leakage integral water
— Leaking through — Aneurysm rupture leakage and water
holes in graft wall entry pressure, as
— Aortic
enlargement appropriate

— Aortic rupture
— Type IV endoleak
Modularity and intend- Dimensional — Prosthesis None ACE2 — Dimensional
ed overlap mismatch component verification
between separation
implant
components — Poor apposition
between components
Inaccurate position- — Branch vessel None ACE2 — Simulated use
ing or orientation prosthesis
compression — Branch vessel — Visibility
or kink blockage

— Prosthesis — Branch vessel

component coverage
separation
Separation between — Prosthesis None ACE2 — Migration
implant components component resistance
separation
simulated — Radial force
— Separation force for
overlapping prostheses
— Simulated use
Angulation or kink — Branch vessel None ACE3 — Resistance to
between prosthesis kinking
implant compression — Branch vessel
components or kink blockage — Simulated use

— Prosthesis kink — Branch vessel

coverage

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Table A.4 (continued)

Potential effect(s) of failure
Potential
Device/Procedure Device effect(s) of failure Clinical Nonclinical
failure
related function(s) effect(s) of device testing
mode(s) Subsequent
Initial effect(s) failure
effect(s)
Damage to, — Branch vessel None ACE1 — Fatigue and
obstruction of, prosthesis durability
or movement compression ACE2
of implant or kink — Simulated use
— Branch vessel
component by blockage
other implant — Prosthesis
component component — Branch vessel
separation coverage
— Graft material holes — Vascular
— Migration injury–
endovascular
— Stent or prosthesis
attachment related
system fracture
Appropriate sizing Excessive — Lack of — Prosthesis kink ACE3 — Computational
recommendations oversizing conformance to analyses
the vessel wall — Dissection
(e.g. bird beaking) creation or — Dimensional
extension verification
— Prosthesis compres-
sion or collapse — False lumen — Fatigue and
patency durability
— Graft material
infolding — False lumen — Implant diameter
perfusion to balloon inflation
pressure
— Thrombosis
— Implant length to
— Type I endoleak diameter
— Vascular relationship
injury– — Radial force
endovascular
prosthesis — Recoil
related
— Simulated use
— White
thrombus
formation
Undersizing — Prosthesis — Prosthesis kink ACE1 — Dimensional
component verification
separation ACE2
— Implant diameter
— Incomplete to balloon inflation
apposition to pressure
vessel wall
— Implant length to
— Migration diameter relationship
— Radial force
— Recoil
— Migration
resistance
— Simulated use

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Table A.4 (continued)

Potential effect(s) of failure
Potential
Device/Procedure Device effect(s) of failure Clinical Nonclinical
failure
related function(s) effect(s) of device testing
mode(s) Subsequent
Initial effect(s) failure
effect(s)
Patency Kinking — Prosthesis kink None ACE3 — Resistance to
kinking
— Embolism
— Simulated use
— White
Improper position- — Lack of None thrombus — Simulated use
ing, configuration conformance to formation
or orientation the vessel wall
(e.g. bird beaking) For TIPS:

— Maldeployment — Recurrence
of portal
— Misaligned hypertension
deployment
Graft material — Graft material None — Simulated use
in-folding in-folding
Prosthesis com- — Prosthesis compres- — Support — Crush resistance,
pression or collapse sion or collapse structure compression resist-
fracture ance, radial force, as
appropriate
— Simulated use
Thrombosis due to — None None — Amputation — Biocompatibility
material-
related factors — Ischaemia
— Limb loss
— Prosthesis occlu-
sion
— Restenosis
— Thrombosis
Branch vessel — Branch vessel pros- None — Branch vessel — Crush resistance,
prosthesis com- thesis blockage compression resist-
pression or kink compression ance, radial force, as
or kink — Branch vessel appropriate
coverage
— Resistance to
— Embolism kinking
— Ischaemia — Simulated use
Magnetic resonance Heating None None — Vascular — MR safety
imaging (MRI) safety injury–
MR related
Lack of quality MRI None None — Inability to
imaging monitor
prosthesis over
time with MR
imaging
— Inadequate
MR imaging
Movement of — Migration None ACE1
implant
— Prosthesis ACE2
component
separation — Dissection
creation or
extension
— MR related

A.3 Identification of appropriate testing for device design modifications and

changes in intended use
Identification of the appropriate testing for device design modifications and changes in intended use
involves identifying the device-related and procedure-related functions that may be affected by each
modification and developing a device evaluation strategy focusing on these functions. This may be

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presented in tabular format, first addressing any design differences and differences in the intended
in vivo environment, followed by a DES table that addresses the device-related and procedure-related
attributes identified in the comparison tables. Examples of these tables are provided in Tables A.5 to A.7.
The tables (e.g. Tables A.5 to A.7) should be complemented by text to explain why other attributes
would not likely be affected by the changes in the device and/or the indications for use.
The testing to be completed on the modified device or for the new intended use and the testing to be
leveraged should also be summarized. This is best presented in tabular format, amending the table in
Annex C to include a column with the rationale for not repeating testing.

Table A.5 — Design comparison between a previously evaluated device and the modified device
Comparison of design feature
characteristics Potentially affected
Device design Design
(Previously device/procedure-
rationale difference (Modified device
evaluated device related functions
name)
name)
State the expected List each design Provide a Provide a List each device-
benefits of the feature that is detailed detailed related and procedure-
modified device different description of description of related function that
design as compared between the relevant design the design feature could be affected by
to the previously previously feature characteristics of the design difference.
evaluated device. evaluated device characteristics the modified
and modified of the previously device, including
Examples of
device to achieve evaluated device, appropriate
expected benefits
the benefit. including quantitative
of design differences
quantitative values.
include reduce Examples of
values as
crossing profile, design feature
appropriate.
improve differences
conformability, include graft Examples of
improve deployment material, stent design feature
accuracy and material, stent characteristics
incorporate visceral geometry, active that may be
branching. fixation system associated with
and addition of a a graft material
branch. include graft
material
processing, graft
weave, graft wall
thickness and
permeability.

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Table A.6 — Indication for use comparison of a previously evaluated device and the study devicea
Comparison of in vivo parameters Potentially affected
Differences in the in vivo
Prior intended New intended device/procedure-related
environment
use use functions
List each in vivo parameter Describe the in Describe the in Identify each individual device-
associated with the different vivo parameter vivo parameter related and procedure-related
intended use (e.g. implant for the for the new function that could be affected
location, anatomical dimensional previously intended use. by the difference in the in vivo
requirements, disease state, lesion evaluated parameter.
type) that may be important in intended use.
assessing device performance.
Examples of in vivo parameters
include blood vessel sizes,
angulation, movement, tortuosity,
compliance and flow characteristics.
a For example, an indication for use change from abdominal aortic aneurysms to thoraco-abdominal aneurysms or a
change of the minimum proximal landing zone length requirement from 15 mm to 10 mm.

Table A.7 — Device evaluation strategy for device design modifications and/or changes in
intended use
Device or Relative potential effects of
procedure- failure
related Value of
function that Potential Potential Potential Device design information Nonclinical
could failure modes device clinical information from previously device testing
potentially be effects of effects of evaluated device
impacted by failure failure
the differences
List each State the List the List the Discuss the Provide an Identify the bench
device-related failures that potential potential relevant explanation tests and analyses
and procedure- might occur effect(s) of effect(s) of information regarding how appropriate to
related function and could the failure the failure considered in information evaluate the
or feature that result in mode on the mode on the the design of the obtained from the function and the
could be affected consequences device. patients. device to explain assessment of the potential failure
by the (effects) to the why the function previously mode(s), taking
difference(s), as device or Describe any Describe will be evaluated device into consideration
identified in patient if the potential any potential maintained or is informative. the information
Table A.5 and/or function is not difference in differences improved. available from the
A.6. maintained or the type or in the type For example, previously
improved. severity of and severity explain how the evaluated device.
the device of the clinical information from
effects of effects of the previously
failure as failure as evaluated device
compared to compared to reflects on
the the
previously previously — the potential
evaluated evaluated for the device to
device. device. achieve the
desired function,
— the likelihood
of the device to
pose a significant
safety risk, or
— the
appropriate
testing to address
the desired
function of the
device (e.g.
information may
be available to
indicate that one
or two tests are
most relevant to
assess a specific
attribute to
predict clinical
performance).

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Annex B
(informative)

Description of clinical and device effects of failure

Table B.1 — Description of clinical effects of failure

Event Description
Adverse biological response Unspecified clinical adverse event caused by use of a non-biocompatible
material.
NOTE   This clinical effect is not commonly reported. It is often not possible
to link an adverse event to a particular material. These events are mitigated
through appropriate biocompatibility testing.
Amputation Removal of a body part due to a lack of viability caused by ischaemia.
Aneurysm enlargement Any enlargement of the diameter or volume of the aneurysm sac greater than
documented measurement error, as determined by contrast-enhanced CT or
other appropriate modality.
Aneurysm rupture Rupture of the treated, native aneurysm sac.
Aortic enlargement An increase in total aortic diameter greater than documented measurement
error as compared to the first post-implant CT measure using orthogonal (i.e.
perpendicular to the centerline) measurements after treatment of a dissection.
Blood loss Any blood loss requiring intervention (i.e. transfusion, medical therapy,
surgical repair).
Branch vessel loss of patency Reduction of blood flow in a branch vessel.
Branch vessel blockage Complete occlusion of a branch vessel prosthesis caused by prosthesis
kinking or compression.
Branch vessel coverage Clinically significant, unplanned exclusion of a major branch vessel by the
endovascular prosthesis.
Branch vessel thrombosis Haemodynamically significant thrombus formation within the lumen of a
branch vessel endovascular prosthesis.
Dissection creation or Creation or extension of a tear within the vessel wall. A dissection can
extension propagate antegrade, retrograde or in both directions.
Procedural dissection Creation or extension of a dissection during the endovascular procedure.
Post-procedural dissection Creation or extension of a dissection due to the creation of a new entry tears
at the margins of the endovascular prosthesis post procedure.
Embolism Migration of intraluminal debris (e.g. thrombus, atheromas material) in the
presence of clinical sequelae.
Endoleak Persistence of blood flow abluminal to the endovascular prosthesis.
Type I An endoleak arising at or from a sealing zone (proximal or distal).
Type Ia A Type I endoleak originating from the proximal fixation zone of the
endovascular prosthesis.
Type Ib A Type I endoleak originating from the distal fixation zone of the
endovascular prosthesis.
Type II A Type II endoleak is caused by retrograde flow from patent branch arteries,
for example, lumbar and intercostal arteries.
Type III An endoleak arising from a defect in the graft material or from an inadequate
seal between modular graft components
Type IIIa A Type III endoleak originating from an inadequate seal between modular
components.

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Table B.1 (continued)

Event Description
Type IIIb A Type III endoleak originating from a defect in the graft material.
Type IV An endoleak through the graft wall due to graft permeability.
False lumen patency Persistence of blood flow into the false lumen after endovascular treatment
of dissection resulting in lack of complete thrombosis.
Patent false lumen Flow present throughout the aortic false lumen in the absence of evidence of
thrombus, within a specific segment of the aorta.
Partially thrombosed false Thrombus within the aortic false lumen that has a residual patent flow
lumen channel, within a specific segment of the aorta.
False lumen perfusion (FLP) Persistence of blood flow into the false lumen from any source after
endovascular treatment of a dissection, analogous to endoleaks for the
treatment of aneurysms.
Primary intimal tear Flow from a proximal aortic source through the primary intimal tear (PIT),
(PIT FLP) into the aortic false lumen (similar to a Type IA endoleak after treatment of
aneurysms).
Proximal aorta (PA FLP) Flow from an aortic source proximal to the endovascular stent-graft, through
an entry tear proximal to the PIT, into the aortic false lumen.
Distal aorta (DA FLP) Flow from an aortic source distal to the endovascular stent-graft, through
fenestrations in the dissection septum, secondary aortic tears or re-entry
points into the aortic false lumen.
Proximal branch (PB FLP) Flow into the aortic false lumen via retrograde flow from aortic arch branch
vessels.
Distal branch (DB FLP) Flow into the aortic false lumen via retrograde flow from distal branch
vessels in the chest (intercostals), abdomen (e.g. mesenteric, renal) or pelvis
(iliac).
Failure to complete device Inability to implant an endovascular graft due to an inability to access the
implantation intended implantation site or to deploy the prosthesis.
Foreign body embolization Intraluminal migration of a piece or pieces of the endovascular system (e.g.
balloon fragments, pieces of a delivery system, fragments of the endovascular
prosthesis).
Inability to monitor prosthesis Inability to monitor device integrity and position over time due to an inability
over time to visualize the device.
Inadequate MR imaging Inability to obtain quality MR imaging due to distortion or imaging artefact
caused by the endovascular prosthesis.
Insertion site infection Development of an insertion site infection.
Ischaemia Oxygen supply decrease due to inadequate blood supply.
Lumen obstruction Blockage of the lumen of an endovascular prosthesis by physical (e.g. kink,
twist, collapse, graft material infolding), rather than physiological, means.
Prosthesis infection Development of a prosthesis infection.
Prosthesis occlusion Complete blockage of the lumen of an endovascular prosthesis.
Recurrence of portal Recurrent high blood pressure in the portal venous system.
hypertension
Restenosis Significant reduction in diameter when compared to the reference diameter.
Thrombosis Haemodynamically significant thrombus formation within the lumen of the
endovascular prosthesis.
Vascular trauma Injuries to vessels as a result of an endovascular procedure,
Access vessel injury Injury to a vessel at the access site during the endovascular procedure which
may result in hematoma or false aneurysm formation.
Access vessel rupture Rupture of an access vessel, including disruption of the vessel during
insertion or removal of the delivery system.

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Table B.1 (continued)

Event Description
Erosion leading to fistula Creation of a fistula caused by erosion of the endovascular prosthesis
formation through the blood vessel and an adjoining structure. The type of fistula
should be specified.
Unintentional dissection Creation of a new entry tear caused by erosion of, or penetration by, the
septum perforation endovascular prosthesis through the dissection septum,
Vascular injury–delivery Blunt traumatic injury to a vessel during an endovascular procedure,
system related including dissection and perforation or injury to a vessel due to a delivery
system or balloon failure, including vessel wall injury that may lead to
stenosis or restenosis,
Vascular injury– Injury to a vessel related to the presence of the endovascular prosthesis
endovascular prosthesis over time, including vessel perforation and rupture.
related
Vascular injury–MR related Injury to a vessel due to heating or device movement during MR imaging.
Vessel rupture Rupture of a vessel due to excessive ballooning.
White thrombus formation Platelet aggregation as a consequence of high shear stress (e.g. caused by
graft infolding in limbs).

Table B.2 — Description of device effects of failure

Event Description
Access failure Failure to reach the intended site with the endovascular system due to mechanical
failure or patient anatomy.
Accessory device Inability to use the accessory device as intended due to mechanical failure.
failure
Active fixation element Fracture or breakage of a positive fixation element (e.g. hook, barb).
(hook/barb) fracture
Balloon rupture Bursting of a balloon used in the deployment, moulding, or touch-up of an
endovascular prosthesis.
Attachment system Loss of securement of the attachment system to the endovascular prosthesis.
disconnection
Branch vessel Significant reduction in luminal diameter due to compression or kink. Contributing
prosthesis factors may include migration of the main body component and aortic remodelling.
compression or kink
Delamination Separation of layers of the graft material used in the construction of an
endovascular prosthesis.
Delivery system damage Damage incurred to the delivery system (e.g. kink, bond failures, complete tip
separation).
Deployment failure Inability to deploy the endovascular prosthesis per the instructions for use.
Balloon-related Inability to fully deploy the endovascular prosthesis due to balloon failure.
deployment failure
Deployment system Inability to deploy the prosthesis at the intended site due to mechanical failure.
failure
Inability to deploy Inability to deploy the prosthesis at the intended site due to patient anatomy.
Graft dilatation or Clinically significant graft dilatation or any graft rupture.
rupture
Graft material holes Holes in the graft material due to suture pull out, suture hole elongation, suture
breaks or wear.
Graft material infolding Clinically significant infolding of the graft material.
Inaccurate deployment Improper positioning, configuration or orientation of the endovascular prosthesis
during deployment.

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Table B.2 (continued)

Event Description
Lack of conformance Incomplete or a loss of apposition of the endovascular prosthesis to the vessel wall
to the vessel wall (e.g. bird beaking).
Maldeployment Asymmetric deployment of the proximal end of a prosthesis (e.g. stent inversion) in
angulated anatomy that could not be corrected prior to completion of the procedure.
Metallic bond fracture Fracture or breakage of metallic bonds (e.g. welds) between support structure
components.
Migration Significant longitudinal movement of an endovascular prosthesis relative to
anatomical landmarks that were determined prior to discharge (e.g. requires
intervention, ≥1 cm).
Misaligned deployment Asymmetric deployment of the proximal end of a prosthesis (e.g. stent inversion) in
angulated anatomy that may be corrected prior to completion of the procedure.
Poor apposition Incomplete apposition between two or more endovascular prostheses or
between components components of a modular system.
Prosthesis component Movement of one or more endovascular components resulting in an inadequate seal
separation between the components.
Prosthesis Significant reduction in luminal diameter due to compression or collapse.
compression or Contributing factors may include excessive oversizing, lack of conformance of the
collapse prosthesis to the vessel wall and local compression.
Prosthesis damage Damage to the prosthesis incurred during access or withdrawal.
Prosthesis Movement of the prosthesis from its intended implantation site during withdrawal
dislodgement of the delivery system.
Prosthesis Inability to deliver and position an endovascular prosthesis at the intended site due
dislodgement from to prosthesis dislodgement from the delivery system.
the delivery system
Prosthesis kink Kinking of the endovascular prosthesis resulting in a significant reduction in blood
flow.
Separation of covering Disconnection between graft material and structural components of the
from stent endovascular prosthesis.
Support structure Fracture or breakage of the support structure or stent.
fracture
Support structure Separation between structural components due to suture or metallic bond breaks.
separation
Suture breaks Breakage of sutures that are intended to connect a graft material to the support
structure of the endovascular prosthesis or sutures that are intended to connect
structural components together.

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Annex C
(informative)

Bench and analytical tests

Table C.1 — Bench and analytical tests

Tests Purpose of test Device/Procedure Design Test
related function(s) evaluation method
section guidance
Active fixation The purpose of this test is to evaluate Prosthesis integrity 8.5.2.3.3 D.5.2.3.3
fatigue and the long-term structural integrity of
durability the securement of the active fixation
components (e.g. barbs, hooks, pins)
to the attachment system (e.g.
proximal stent), and the securement
of the attachment system to the
endovascular prosthesis body when
subjected to cyclic loading conditions.
Axial fatigue The purpose of this test is to evaluate Prosthesis integrity 8.5.2.3.4 D.5.2.3.4
and durability the long-term structural integrity of
Appropriate sizing
the endovascular prosthesis when
recommendations
subjected to cyclic axial loading
conditions.
Balloon burst The purpose of this test is to Ability to deploy 8.5.1.1.1 D.5.1.1.1
pressure for determine the mean and rated burst
Delivery system
non-compliant pressure (RBP) of the balloon when
integrity
balloons inside of the endovascular prosthesis.
Balloon The purpose of this test is to deter- Ability to withdraw 8.5.1.1.2 D.5.1.1.2
deflation time mine the time required to completely
deflate the balloon when inside of the
endovascular prosthesis.
Balloon rated The purpose of this test is to Delivery system 8.5.1.1.3 D.5.1.1.3
fatigue determine the ability of the balloon, integrity
when inside of the endovascular
prosthesis, to withstand repeated
inflation cycles to the maximum
recommended pressure or volume,
taking into consideration the number
of inflation cycles expected clinically.
Balloon volume to The purpose of this test is to Ability to deploy 8.5.1.1.4 D.5.1.1.4
burst for compliant determine the volume required to
Delivery system
balloons burst a compliant balloon when
integrity
inside of the endovascular prosthesis.
Bending fatigue The purpose of this test is to evaluate Prosthesis integrity 8.5.2.3.5 D.5.2.3.5
and durability the long-term structural integrity of
Appropriate sizing
the endovascular prosthesis when
recommendations
subjected to cyclic bending loading
conditions.
Biocompatibility The purpose of biocompatibility tests Patency 8.5.1.9 See
are included in the ISO 10993- series. ISO 10993- se-
Biocompatibility
ries

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Table C.1 (continued)

Tests Purpose of test Device/Procedure Design Test
related function(s) evaluation method
section guidance
Burst strength The purpose of this test is to Prosthesis integrity 8.5.2.8.1 D.5.2.8.1
determine the pressurized burst
strength of the graft material, or
alternatively, the burst strength of
the entire endovascular prosthesis if
processing may reduce the strength
of the graft material.
Compression The purpose of this test is to Patency 8.5.2.5.1 D.5.2.5.1
resistance to determine the force at which a pre-
perpendicularly specified displacement occurs under
applied load a load applied perpendicular to the
(self-expanding, longitudinal axis of the prosthesis.
non-aortic
endovascular
prostheses)
Corrosion The purpose of this assessment is Prosthesis integrity 8.5.2.1 D.5.2.1
to evaluate the susceptibility of the
metallic materials of the endovascular
prosthesis to corrosion.
Crush resistance The purpose of this test is to Patency 8.5.2.5.2 D.5.2.5.2
with determine the force at which a
perpendicularly pre-specified amount of permanent
applied load deformation occurs under a load
(balloon- applied perpendicular to the
expandable, longitudinal axis of the prosthesis.
non-aortic
endovascular
prostheses)
Crush resistance The purpose of this test is to Patency 8.5.2.5.3 D.5.2.5.3
with radially determine the radially applied load
applied load at which a pre-specified amount of
(balloon- permanent deformation occurs.
expandable
endovascular
prostheses)
Dimensional The purpose of this test is for Modularity and 8.5.2.7.1 D.5.2.7.1
verification of verification to design specifications, intended overlap
the endovascular to determine the graft material wall
Appropriate sizing
prosthesis thickness(es) and the endovascular
recommendations
prosthesis dimensions in the
deployed state, including the
length(s), outer diameter(s) and all
other appropriate dimensions.
Dimensional The purpose of this test is to Ability to access 8.5.1.2 D.5.1.2
verification of determine the endovascular system
Atraumatic
the endovascular dimensions, for verification to design
introduction,
system specifications, including the useable
tracking and
length, profile and all other
withdrawal
appropriate dimensions.
Haemostasis

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Table C.1 (continued)

Tests Purpose of test Device/Procedure Design Test
related function(s) evaluation method
section guidance
Dislodgement The purpose of the test is to Ability to access 8.5.1.3 D.5.1.3
force (pre- determine the force required to
mounted, displace the pre-mounted
balloon- endovascular prosthesis from its
expandable position on the non-expanded
endovascular balloon.
prostheses)
Factory seam The purpose of this test is to Prosthesis integrity 8.5.2.8.2 D.5.2.8.2
strength determine the tensile strength of
(endovascular any factory manufactured seams in
grafts with the graft material. This requirement
seams in the graft is not intended to apply to any
material) connections between stents or
between the graft material and a
stent or an attachment system.
Fatigue and The purpose of the computational Prosthesis integrity 8.5.2.2 D.5.2.2
durability- analyses is to determine the
Appropriate sizing
computational magnitude and location of the
recommendations
analyses maximum stresses and/or strains
and fatigue safety factors for each
appropriate loading scenario based
upon the intended clinical
application and device design.
Appropriate computational analysis
tools, such as finite element analysis
(FEA), can be used to calculate the
stresses and/or strains. The stresses
and/or strains can be compared to
material characteristics to calculate
the fatigue safety factor.
Fatigue and Evaluate the long-term structural Prosthesis integrity 8.5.2.3 D.5.2.3
durability–in integrity of the endovascular
Appropriate sizing
vitro testing prosthesis under cyclic loading
recommendations
conditions that represent the in vivo
(See the specific
environment. This can require
Fatigue and
several different test configurations.
Durability tests
for the associated
specific
purposes.)
Force to deploy The purpose of this test is to Ability to deploy 8.5.1.4 D.5.1.4
determine the force to deploy the
endovascular prosthesis under
simulated anatomical conditions. All
applicable steps of the deployment
process should be evaluated.
Haemostasis The purpose of this test is to evaluate Haemostasis 8.5.1.8 D.5.1.8
the ability of any hemostatic seal or
valve in the delivery system to
minimize leakage of blood.

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Table C.1 (continued)

Tests Purpose of test Device/Procedure Design Test
related function(s) evaluation method
section guidance
Implant The purpose of this test is to Appropriate sizing 8.5.2.7.2 D.5.2.7.2
diameter to determine the relationship between recommendations
balloon inflation the prosthesis diameter and the
pressure balloon inflation pressure for
(balloon- balloon-expandable endovascular
expandable prostheses.
endovascular
prostheses)
Implant length The purpose of this test is to Ability to deploy 8.5.2.7.3 D.5.2.7.3
to diameter determine the relationship between
Appropriate sizing
relationship the length and diameter for
recommendations
(endovascular endovascular prostheses that have
prostheses that clinically relevant length changes
have clinically with diameter changes.
relevant length
changes with
diameter changes)
Integral water The purpose of this test is to Appropriate 8.5.2.6.1 D.5.2.6.1
leakage evaluate the water leakage between permeability
modular components and through
holes in the graft material resulting
from the construction of the
endovascular prosthesis (e.g. holes
created by suturing stent structures
to the graft material).
Leakage at seal This test applies to a device design Adequate seal 8.5.2.4.1 D.5.2.4.1
zone modification that may affect the seal
Appropriate
zone(s).
permeability
Determine the leakage between the
seal zone(s) of the endovascular
prosthesis and a mock artery and
compare the results to those for the
unmodified device. This requirement
can alternatively be met through
evaluation of Type I endoleaks in a
clinical study.
The evaluation of seal zone leakage
is not necessary for endovascular
prostheses intended for clinical uses
for which seal zone leakage is
unlikely to occur or would not likely
be associated with adverse clinical
sequelae (e.g. treatment of occlusive
lesions).
Longitudinal The purpose of this test is to Prosthesis integrity 8.5.2.8.3 D.5.2.8.3
tensile strength determine the longitudinal tensile
strength of the graft material.

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Table C.1 (continued)

Tests Purpose of test Device/Procedure Design Test
related function(s) evaluation method
section guidance
Magnetic The purpose of MRI safety testing is Magnetic 8.5.2.9 See
Resonance to evaluate the potential for 1) resonance imaging ASTM F2503,
Imaging (MRI) magnetically induced displacement (MRI) safety ASTM F2052,
safety force and torque; and 2) RF induced ASTM F2119,
heating of the prosthesis and to ASTM F2182,
determine the appropriate MR safety ASTM F2213
term (i.e. MR Safe, MR Conditional, or
MR Unsafe) as defined in
ASTM F2503.
Migration The purpose of this test is to Fixation 8.5.2.4.2 D.5.2.4.2
resistance evaluate the ability of the effectiveness
endovascular prosthesis to resist
Appropriate sizing
migration when subjected to force
recommendations
or pressure. The evaluation of
migration resistance is not Modularity and
necessary for endovascular intended overlap
prostheses intended for clinical
uses for which migration is unlikely
to occur or would not likely be
associated with adverse clinical
sequelae (e.g. treatment of occlusive
lesions).
Porosity The purpose of this test is to Appropriate 8.5.2.6.2 D.5.2.6.2
(non-textile determine the porosity of the permeability
materials) endovascular prostheses
constructed of non-textile materials.
Radial fatigue The purpose of this test is to Prosthesis integrity 8.5.2.3.2 D.5.2.3.2
and durability evaluate the long-term structural
Appropriate sizing
integrity of the endovascular
recommendations
prosthesis when subjected to cyclic
radial loading conditions.
Radial force The purpose of this test is to Fixation 8.5.2.5.4 D.5.2.5.4
(self-expanding determine the outward force as a effectiveness
endovascular function of the diameter of the
Modularity and
prostheses) endovascular prostheses.
intended overlap
Appropriate sizing
recommendations
Patency
Recoil (balloon- The purpose of this test is to Fixation 8.5.2.7.4 D.5.2.7.4
expandable determine the amount of elastic effectiveness
endovascular recoil (percent of the diameter
Appropriate sizing
prostheses) reduction), after the deployment of
recommendations
a balloon-expandable prosthesis.
Resistance to The purpose of this test is to Modularity and 8.5.2.5.5 D.5.2.5.5
kinking determine the minimum radius
intended overlap
(flexibility) that the endovascular prosthesis can
accommodate without kinking. Patency

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Table C.1 (continued)

Tests Purpose of test Device/Procedure Design Test
related function(s) evaluation method
section guidance
Separation force Determine the force required to Fixation effective- 8.5.2.4.3 D.5.2.4.3
for overlapping separate overlapping endovascular ness
endovascular prostheses or modular components
Modularity and
prostheses (e.g. main body, cuffs, extenders) in
intended overlap
the deployed state. The evaluation of
separation force is not necessary for
endovascular prostheses intended
for clinical uses for which
component separation is unlikely
to occur or would not likely be
associated with adverse clinical
sequelae (e.g. treatment of occlusive
lesions).
Simulated use The purpose of this test is to Ability to access 8.5.1.5 D.5.1.5
evaluate the ability to access, deploy
Ability to deploy
and withdraw the endovascular
system, including pushability, Ability to withdraw
flexibility, torquability, trackability
and deployment accuracy using an Atraumatic
anatomical model(s) that is (are) introduction,
representative of the anatomical tracking and
variation in the intended patient withdrawal
population. This test is also intended Delivery system
to evaluate the compatibility of the integrity
endovascular system with accessory
devices and to evaluate the Prosthesis integrity
occurrence of visible particle Adequate seal
generation associated with access,
deployment and withdrawal of the Modularity and
endovascular system. Additionally, intended overlap
this test is intended to evaluate the Appropriate sizing
conformability of the deployed recommendations
prosthesis to the vessel wall,
positioning (including orientation, if Patency
applicable) and absence of anomalies
(e.g. kinks, twists, component
separation, non-uniform expansion,
prosthesis damage).
Sterilization Sterilization shall be ensured in Sterility 8.5.1.10 See
assurance accordance with appropriate appropriate
International Standards. International
Standards
Strength after The purpose of this test is to Prosthesis integrity 8.5.2.8.4 D.5.2.8.4
repeated determine the strength of the
puncture endovascular prostheses following
(endovascular repeated dialysis-needle punctures
prostheses for for a prosthesis that will be
vascular access) cannulated to provide blood access
for haemodialysis.

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Table C.1 (continued)

Tests Purpose of test Device/Procedure Design Test
related function(s) evaluation method
section guidance
Strength of the The purpose of this test is to Prosthesis integrity 8.5.2.8.5 D.5.2.8.5
connection(s) determine the strength of the
between the graft connection(s) between the graft
material and a material and the fixation system(s).
discrete fixation This test applies to prostheses with a
system(s) fixation system that is discrete from
any stent(s) intended to provide
structural support within the
prosthesis (e.g. suprarenal stent that
is not continuous with the stent(s) in
the prosthesis body).
Additionally, the purpose of this test
is to determine the securement of a
fixation system (e.g. suprarenal
stent) to the endovascular prosthesis
body and not to evaluate the
securement of an active fixation
component (e.g. barb, hook, pin) to
the fixation system or graft material.
As such, the location or presence of
an active fixation component is not
relevant for this test.
Tensile bond The purpose of this test is to Delivery system 8.5.1.6 D.5.1.6
strength determine the bond strength of the integrity
joints and/or fixed connections of the
delivery system and to evaluate the
strength of the segments adjacent to
the bonds of the delivery system (e.g.
sheath, tubing), either separately or
concurrently.
Torsional bond The purpose of this test is to Ability to access 8.5.1.7 D.5.1.7
strength determine the torque required to
Delivery system
cause failure of the joints and/or
integrity
fixed connections in the appropriate
segments of the delivery system (i.e.
joints and/or fixed connections that
are subjected to torsion during
clinical use) and to evaluate the
torsional strength of the segments
adjacent to the bonds of the delivery
system (e.g. sheath, tubing), either
separately or concurrently.
Torsional fatigue The purpose of this test is to evaluate Prosthesis Integrity 8.5.2.3.6 D.5.2.3.6
and durability the long-term structural integrity of
Appropriate sizing
the endovascular prosthesis when
subjected to cyclic torsional loading recommendations
conditions.

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Table C.1 (continued)

Tests Purpose of test Device/Procedure Design Test
related function(s) evaluation method
section guidance
Visibility The purpose of this test is to evaluate Modularity and 8.5.1.11 D.5.1.9
the ability to visualize the intended overlap
endovascular system and
Visualization
endovascular prosthesis using the
imaging techniques specified in the
instructions for use (IFU).
Water entry pres- The purpose of this test is to Appropriate 8.5.2.6.3 D.5.2.6.3
sure (non-textile determine the pressure required permeability
materials) to force water through a non-textile
graft material of an endovascular
prosthesis.
Water The purpose of this test is to Appropriate 8.5.2.6.4 D.5.2.6.4
permeability determine the water flow rate permeability
(textile materials) through the graft material of an
endovascular prostheses constructed
with a water-permeable graft
material (e.g. woven graft material).

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Annex D
(informative)

Test methods

D.1 General
The information included in this annex is intended to provide guidance for preclinical in vitro testing
performed in order to verify the design of the endovascular system. Guidance for reporting the test
results is also provided. It is recognised that not all the tests described in this annex are applicable to all
system designs. It is also recognised that testing intended to ensure that the device meets specifications
during manufacture may be conducted in a manner other than those outlined in this annex.
Guidance for developing appropriate test methods is included in this annex allowing flexibility in
designing appropriate methodologies for specific device designs and indications for use. To enhance
consistency in the testing of devices, use of methods developed based on the steps and concepts outlined
in this annex is recommended. If alternative methods are employed, these methods should be justified.
It is recognised that some tests listed in this annex can be combined. For combined tests, the report
should provide the individual test results for each of the tests listed in this annex, if appropriate.
As identified in Table D.1, some requirements in the body of this document do not have associated test
method guidance in this annex, as the methodologies are better addressed by other standards (e.g. MRI
safety).
Modifications to existing test methods or inclusion of additional test methods might be required for
various endovascular system designs. When identifying testing conditions, attention should be paid
to the relevant physiological conditions. A simulated physiological environment (e.g. a temperature
controlled water bath) should be used when appropriate.
To ensure valid results, measurement equipment used during testing should have appropriate precision
and accuracy, and be calibrated or verified against traceable measurement standards, as appropriate.
The precision and accuracy should be adequate to determine the measured value relative to the
acceptance criteria.
NOTE Although this is an informative annex, the use of the terms “should” and “shall” are intended to
differentiate between considerations and essential components of the methods, respectively.

D.2 Sampling
A sampling plan should be used that will ensure that adequate representation of the data has been
obtained for each characteristic measured. It should be verified that the design attributes of the
endovascular system are representative of the devices to be released for distribution, including all
sizes, configurations and components.
If the purpose of the test is to evaluate the interaction between modular components or overlapping
prostheses (e.g. separation force for overlapping endovascular prostheses), or if the attribute under
test could be significantly affected by the overlap (e.g. ability to resist kinking), the test articles should
include overlapped components.
The sampling should fully represent the range of device sizes and may not necessarily require the
testing of each size. It may be necessary to conduct an analysis to identify the size(s) of the device with
the greatest potential for failure. A rationale should be provided for sample selection.
Segments or portions of complete prostheses may be used as the test articles, if appropriately justified.

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The need for testing of more than one area in an endovascular prosthesis to ensure adequate
characterization for some parameters (e.g. proximal and distal diameters in a tapered prosthesis,
wall thickness in devices with non-uniform wall thickness) should be considered in establishing the
sampling plan.
For all tests, the number of samples should be justified.
Additional recommendations regarding sampling may be included in individual test methods, as
appropriate.

D.3 Conditioning of test samples

All samples should be subjected to sterilization, including multiple sterilizations, if appropriate, unless
justification is provided for use of non-sterilized products.
Samples should be subjected to conditions that are normally encountered that can affect the test
results. Examples of conditioning are preparation of the endovascular system, loading of the prosthesis
inside the delivery catheter, passage through simulated tortuous vasculature, warming of the system to
body temperature and deployment of the prosthesis.

D.4 Reporting
For the purposes of this annex, reporting relates to requests from a National Regulatory Authority.
The design evaluation report should include an appropriate table of contents and four main sections: a)
background, b) an executive summary, c) individual test summaries and d) appendices that include the
device evaluation strategy and the detailed reports. Pages should be numbered sequentially throughout
the document (including appendices).
a) The background section should describe the device design concept.
b) The executive summary should include the following:
— a description of the bench testing and analyses that have been performed;
— a summary of the device evaluation strategy, including justification for the omission of tests
identified in this document;
— a table to summarize the testing completed, with the following columns: name of test, test
purpose, test sample description, number of samples, acceptance criteria, summary of results
and cross references to the test summary and full test report.
c) Individual test summaries should include the following:
— a brief summary of the purpose, methods, and results;
— the significance of the test results;
— for tests with acceptance criteria, justification for the criteria, or
— for characterization tests, an explanation of the relevance of the results.
d) Individual test reports should include the following information:
— purpose: state the purpose of the test as it corresponds to this document;
— materials: list significant materials (e.g. test articles with lot/serial numbers or other
appropriate means of traceability, critical equipment) used in performing the test, using figures
and diagrams as appropriate;

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— sampling: state the sampling plan, including the basis for and the number of samples tested and
justification for the selection of test articles (e.g. sizes, conditioning);
— acceptance criteria, if applicable: state the criteria for the test results, including justification
and/or clinical relevance;
Clinical applicability of the acceptance criteria shall take into consideration the anatomical and
physiological conditions of the intended use.
— test method: describe in detail the method used to perform the test, including any prospectively
defined inspection procedures, and provide a justification for relevant test parameters;
— protocol deviations: describe any deviations and their potential significance on the interpretation
of the results;
— expression of results: report testing results expressed in units as indicated in the test method;
— conclusions: state conclusions, based on comparing results to acceptance criteria or provide an
explanation of the relevance of the results for characterization tests and, if appropriate, include
a discussion on the potential clinical significance of the results.

D.5 Test method development guidance

This clause lists guidelines for tests where appropriate. An index of test methods is given in Table D.1.

Table D.1 — Index of test methods

Design Tests Annex D
evaluation subclause
section
8.5.1 Endovascular system D.5.1
8.5.1.1 Balloon testing D.5.1.1
8.5.1.1.1 Balloon burst pressure for non-compliant balloons D.5.1.1.1
8.5.1.1.2 Balloon deflation times D.5.1.1.2
8.5.1.1.3 Balloon rated fatigue D.5.1.1.3
8.5.1.1.4 Balloon volume to burst for compliant balloons D.5.1.1.4
8.5.1.2 Dimensional verification of the endovascular system D.5.1.2
8.5.1.3 Dislodgement force (pre-mounted, balloon-expandable endovascular D.5.1.3
prostheses)
8.5.1.4 Force to deploy D.5.1.4
8.5.1.5 Simulated Use D.5.1.5
8.5.1.6 Tensile bond strength D.5.1.6
8.5.1.7 Torsional bond strength D.5.1.7
8.5.1.8 Haemostasis D.5.1.8
8.5.1.9 Biocompatibility See
ISO 10993-1
and other
appropriate
parts
8.5.1.10 Sterilization assurance See
appropriate
International
Standards
8.5.1.11 Visibility D.5.1.9
8.5.2 Endovascular prosthesis D.5.2

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Table D.1 (continued)

Design Tests Annex D
evaluation subclause
section
8.5.2.1 Corrosion D.5.2.1
8.5.2.2 Fatigue and durability — Computational analyses D.5.2.2
8.5.2.3 Fatigue and durability — in vitro testing D.5.2.3
8.5.2.3.1 General D.5.2.3.1
8.5.2.3.2 Radial fatigue and durability D.5.2.3.2
8.5.2.3.3 Active fixation fatigue and durability D.5.2.3.3
8.5.2.3.4 Axial fatigue and durability D.5.2.3.4
8.5.2.3.5 Bending fatigue and durability D.5.2.3.5
8.5.2.3.6 Torsional fatigue and durability D.5.2.3.6
8.5.2.4 Fixation and Seal D.5.2.4
8.5.2.4.1 Leakage at seal zone D.5.2.4.1
8.5.2.4.2 Migration resistance D.5.2.4.2
8.5.2.4.3 Separation force for overlapping endovascular prostheses D.5.2.4.3
8.5.2.5 Patency-related tests D.5.2.5
8.5.2.5.1 Compression resistance to perpendicularly applied load (self-expanding, D.5.2.5.1
non-aortic endovascular prostheses)
8.5.2.5.2 Crush resistance with perpendicularly applied load (balloon-expandable, D.5.2.5.2
non-aortic endovascular prostheses)
8.5.2.5.3 Crush resistance with radially applied load (balloon-expandable D.5.2.5.3
endovascular prostheses)
8.5.2.5.4 Radial force (self-expanding endovascular prostheses) D.5.2.5.4
8.5.2.5.5 Resistance to kinking (flexibility) D.5.2.5.5
8.5.2.6 Permeability D.5.2.6
8.5.2.6.1 Integral water leakage D.5.2.6.1
8.5.2.6.2 Porosity (non-textile materials) D.5.2.6.2
8.5.2.6.3 Water entry pressure (non-textile materials) D5.2.6.3
8.5.2.6.4 Water permeability (textile materials) D5.2.6.4
8.5.2.7 Sizing-related testing D.5.2.7
8.5.2.7.1 Dimensional verification of the endovascular prosthesis D.5.2.7.1
8.5.2.7.2 Implant diameter to balloon inflation pressure (balloon-expandable D.5.2.7.2
endovascular prostheses)
8.5.2.7.3 Implant length to diameter relationship (endovascular prostheses that have D.5.2.7.3
clinically relevant length changes with diameter changes)
8.5.2.7.4 Recoil (balloon-expandable endovascular prostheses) D.5.2.7.4
8.5.2.8 Strength D.5.2.8
8.5.2.8.1 Burst strength D.5.2.8.1
8.5.2.8.2 Factory anastomotic strength (endovascular grafts with seams in the graft D.5.2.8.2
material)
8.5.2.8.3 Longitudinal tensile strength D.5.2.8.3

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Table D.1 (continued)

Design Tests Annex D
evaluation subclause
section
8.5.2.8.4 Strength after repeated puncture (endovascular prostheses for vascular D.5.2.8.4
access)
8.5.2.8.5 Strength of the connection(s) or bond(s) between the graft material and the D.5.2.8.5
stent(s) or attachment system(s)
8.5.2.9 Magnetic Resonance Imaging (MRI) safety See
appropriate
International
Standards

D.5.1 Endovascular system

This subclause describes testing that includes the endovascular system, the delivery system without
the endovascular prosthesis and balloons integral to the endovascular system and accessory balloons
used to achieve adequate apposition of the prosthesis.

D.5.1.1 Balloon testing

The following tests apply to balloons integral to the endovascular system and accessory balloons used
to achieve adequate apposition of the prosthesis.

D.5.1.1.1 Balloon burst pressure for non-compliant balloons

D.5.1.1.1.1 Purpose

The purpose of this test is to determine the mean and rated burst pressure (RBP) of the balloon when
inside of the endovascular prosthesis.

D.5.1.1.1.2 Materials

The following materials apply:

— endovascular system for devices with balloons integral to the system or endovascular prosthesis
and balloon catheter for balloons that are not integral to the system;
— recommended guide wire or equivalent;
— temperature controlled water bath (37 ± 2) °C;
— fluid for inflation (e.g. room temperature water);
— leak detection mechanism (e.g. dye in the test fluid, pressure drop monitor, flow rate monitor);
— inflation device, syringe or equivalent, fitted with a means of measuring pressure and capable of
maintaining the inflation pressure;
— timer with an accuracy of ±1 s.

D.5.1.1.1.3 Sampling

Sampling shall be in accordance with D.2.

D.5.1.1.1.4 Conditioning

Conditioning shall be in accordance with D.3.

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D.5.1.1.1.5 Test method

Develop a test method based on the following steps:

a) For balloon expandable endovascular prostheses, submerge the endovascular system in the water
bath and complete any pre-balloon inflation steps per the IFU.
For self-expanding endovascular prostheses, submerge a deployed endovascular prosthesis in the
water bath, insert the guide wire and advance the balloon over the guide wire into the endovascular
prosthesis.
An endovascular system may be used to deploy the endovascular prosthesis in the water bath.
b) Initiate inflation of the balloon, bringing the balloon to the nominal inflation pressure.
c) Incrementally increase the pressure and hold the pressure for a minimum of 10 s after each
increment.
d) Monitor the system after each incremental increase for any persistent leak or decrease in pressure.
e) Repeat steps c) and d) until a persistent leak or decrease in pressure is detected, whether due to
failure of the balloon, shaft or proximal or distal seals.
f) Record the burst pressure and describe the location and failure mode [e.g. seal leaks, balloon
rupture (including orientation of rupture) or fragmentation].
g) Calculate the rated burst pressure. The rated burst pressure (RBP) is based upon the results of this
testing that shows statistically with at least a 95 % confidence that 99,9 % of the balloons will not
burst at or below this pressure. The RBP can be calculated in the following manner.
Using a one-sided tolerance limit for a normal distribution:
RBP = X − K(SD) (D.1)

where

X is the mean balloon burst pressure;

SD is the standard deviation of balloon burst pressure;

K is the factor of one-sided tolerance limit for a normal distribution (K is found in statistical
tables and is dependent on P, C, and N);

P 0,999 (99,9 % reliability);

C 0,95 (95 % confidence);

N is the number of balloons tested.

D.5.1.1.1.6 Expression of results

The burst pressures should be expressed in atmospheres (atm).

D.5.1.1.1.7 Test report

The test report shall be in accordance with D.4 and shall include the mean burst pressure (MBP),
the calculated RBP, the maximum, minimum and standard deviation of the burst data and observed
failure modes.

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D.5.1.1.2 Balloon deflation times

D.5.1.1.2.1 Purpose

The purpose of this test is to determine the time required to completely deflate the balloon when inside
of the endovascular prosthesis.

D.5.1.1.2.2 Materials

The following materials apply:

— endovascular system for devices with balloons integral to the system or endovascular prosthesis
and balloon catheter for balloons that are not integral to the system;
— recommended guide wire or equivalent;
— temperature controlled water bath (37 ± 2) °C;
— contrast medium or equivalent fluid, in accordance with the instructions for use (IFU);
— inflation device, syringe or equivalent, fitted with a means of measuring pressure or volume, and of
maintaining the inflation pressure or volume;
— timer with an accuracy of ±1 s.

D.5.1.1.2.3 Sampling

Sampling shall be in accordance with D.2.

D.5.1.1.2.4 Conditioning

Conditioning shall be in accordance with D.3.

D.5.1.1.2.5 Test method

Develop a test method based on the following steps:

a) For balloon expandable endovascular prostheses, submerge the endovascular system in the water
bath and complete any pre-balloon inflation steps per the IFU.
For self-expanding endovascular prostheses, submerge a deployed endovascular prosthesis in the
water bath, insert the guide wire and advance the balloon over the guide wire into the endovascular
prosthesis.
An endovascular system may be used to deploy the endovascular prosthesis in the water bath.
b) Inflate the balloon in accordance with the IFU.
c) Deflate the balloon in accordance with the IFU and record the time it takes to deflate the balloon.

D.5.1.1.2.6 Expression of results

The deflation time should be expressed in seconds (s).

D.5.1.1.2.7 Test report

The test report shall be in accordance with D.4 and include the maximum, minimum, mean and standard
deviation of the balloon deflation time. The definition of the deflation endpoint and the fluid used for
inflation shall also be reported.

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D.5.1.1.3 Balloon rated fatigue

D.5.1.1.3.1 Purpose

The purpose of this test is to determine the ability of the balloon when inside of the endovascular
prosthesis to withstand repeated inflation cycles to the maximum recommended pressure or volume,
taking into consideration the number of inflation cycles expected clinically.

D.5.1.1.3.2 Materials

The following materials apply:

— endovascular system for devices with balloons integral to the system or endovascular prosthesis
and balloon catheter for balloons that are not integral to the system;
— recommended guide wire or equivalent;
— temperature controlled water bath (37 ± 2) °C;
— fluid for inflation (e.g. room temperature water);
— leak detection mechanism (e.g. dye in the test fluid, pressure drop monitor, flow rate monitor);
— inflation device, syringe or equivalent, fitted with a means of measuring pressure or volume and
capable of maintaining the inflation pressure or volume;
— compliant tube (with a clinically relevant compliance) of a diameter which represents the largest
recommended vessel diameter for the prosthesis under test if necessary to keep the prosthesis from
moving excessively during the inflation cycles;
— timer with an accuracy of ±1 s.

D.5.1.1.3.3 Sampling

Sampling shall be in accordance with D.2.

D.5.1.1.3.4 Conditioning

Conditioning shall be in accordance with D.3.

D.5.1.1.3.5 Test method

Develop a test method based on the following steps:

a) For balloon expandable endovascular prostheses, submerge the endovascular system in the
water bath and deploy the endovascular prosthesis in the water bath or in the compliant tube,
as appropriate, inflating the balloon using a clinically relevant rate, to the maximum pressure or
volume as indicated in the instructions for use (IFU), for a minimum of 10 s or for the length of time
stated in the IFU.
b) For self-expanding endovascular prostheses:
1) submerge the deployed endovascular prosthesis in the water bath or in the compliant tube, as
appropriate;
An endovascular system may be used to deploy the endovascular prosthesis in the water bath.
2) insert the guide wire and advance the balloon over the guide wire into the endovascular
prosthesis;

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3) inflate the balloon using clinically relevant rates to the maximum pressure or volume, as
indicated in the instructions for use (IFU), for a minimum of 10 s or for the length of time stated
in the IFU.
c) Deflate the balloon.
d) Repeat steps a) and b), with the balloon inside of the endovascular prosthesis, a clinically relevant
number of inflation cycles.
The number of inflation cycles may be more than the number expected clinically in order to provide
an appropriate factor of safety.
e) If any persistent leak or decrease of pressure or volume occurs during testing, record the number
of cycles and the mode of failure [e.g. seal leaks, balloon rupture (including orientation of rupture)
or fragmentation]. Any such leak or decrease in pressure due to failure of the balloon, shaft or
proximal or distal seals should be considered a failure in this test.

D.5.1.1.3.6 Expression of results

The maximum inflation diameter, pressure or volume used shall be expressed with diameter in
millimetres (mm), pressure in atmospheres (atm) or volume in millilitres (ml).

D.5.1.1.3.7 Test report

The test report shall be in accordance with D.4 and shall include the number of cycles successfully
completed, the maximum number of cycles expected clinically, any observed failure modes and the
maximum inflation diameter, pressure or volume. The selected tube diameter(s), if used for testing,
shall be justified.
NOTE Additional information can be found in ISO 10555-4.

D.5.1.1.4 Balloon volume to burst for compliant balloons

D.5.1.1.4.1 Purpose

The purpose of this test is to determine the volume required to burst a compliant balloon when inside
of an endovascular prosthesis.

D.5.1.1.4.2 Materials

The following materials apply:

— endovascular system for devices with balloons integral to the system or endovascular
prosthesis and balloon catheter for balloons that are not integral to the system;
— recommended guide wire or equivalent;
— temperature controlled water bath (37 ± 2) °C;
— fluid for inflation (e.g. room temperature water);
— leak detection mechanism (e.g. dye in the test fluid, pressure drop monitor, flow rate monitor);
— inflation device, syringe or equivalent, fitted with a means of measuring volume and capable of
maintaining the inflation volume;
— timer with an accuracy of ±1 s.

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D.5.1.1.4.3 Sampling

Sampling shall be in accordance with D.2.

D.5.1.1.4.4 Conditioning

Conditioning shall be in accordance with D.3.

D.5.1.1.4.5 Test method

Develop a test method based on the following steps:

a) For balloon expandable endovascular prostheses, submerge the endovascular system in the water
bath and complete any pre-balloon inflation steps per the IFU.
For self-expanding endovascular prostheses, submerge a deployed endovascular prosthesis in the
water bath, insert the guide wire and advance the balloon over the guide wire into the endovascular
prosthesis.
An endovascular system may be used to deploy the endovascular prosthesis in the water bath.
b) Using an inflation rate simulating clinical use, inflate the balloon to the diameter of the tube and
hold the diameter for a minimum of 10 s. Record the volume (V1).
c) Incrementally, increase the volume and hold the volume for a minimum of 10 s after each increment.
d) Monitor the system after each incremental increase for any persistent leak or decrease in volume.
e) Repeat steps c) and d) until a persistent leak or decrease of volume or pressure is detected, whether
due to failure of the balloon, shaft or proximal or distal seals.
f) Record the volume at burst (V2), describe the location of the failure and the failure mode [e.g.
fragmentation, seal leaks, balloon rupture (including orientation of rupture)].

D.5.1.1.4.6 Expression of results

Volume shall be expressed in millilitres (ml).

D.5.1.1.4.7 Test report

The test report shall be in accordance with D.4 and shall include the maximum, minimum, mean and
standard deviation of the volume at the specified diameter, the volume at failure and the observed
failure location and failure mode(s).

D.5.1.2 Dimensional verification of the endovascular system

D.5.1.2.1 Purpose

The purpose of this test is to determine the endovascular system dimensions for verification to design
specifications including the useable length, profile and all other appropriate dimensions.
NOTE Measure the delivery system with the endovascular prostheses loaded on the system. See D.5.2.7.1 for
dimensional verification of the endovascular prosthesis.

D.5.1.2.2 Materials

The following materials apply:

— endovascular system;

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— equipment for establishing the profile of the endovascular system:

— measuring equipment for diameters (e.g. micrometer, optical profile projector, laser-
micrometer);
— appropriate profile hole gauges;
— measuring equipment for length.

D.5.1.2.3 Sampling

Sampling shall be in accordance with D.2. The sampling plan shall include each type of modular
component unless justification is provided for exclusion of a component(s).

D.5.1.2.4 Conditioning

Conditioning shall be in accordance with D.3.

D.5.1.2.5 Test method

Develop a test method based on the following steps:

a) Establish the profile of the endovascular system using one of the following methods:
1) measure the maximum outer diameter of the endovascular system using the appropriate
measuring instrument, or
2) verify that the outer diameter fits through the appropriately sized profile hole gauge.
It is only necessary to evaluate the region of the endovascular system intended to be passed
through the specified introducer sheath. Consideration should be given to the potential for
asymmetry.
b) Measure the length of the endovascular system using an appropriate measuring instrument. It is
only necessary to measure the region of the endovascular system intended to be passed through
the introducer sheath.
c) Measure all other appropriate dimensions.

D.5.1.2.6 Expression of results

Length shall be expressed in centimeters (cm). Other dimensions shall be expressed in millimetres (mm).

D.5.1.2.7 Test report

The test report shall be in accordance with D.4. The test report shall include the maximum, minimum,
mean and standard deviation of all measured dimensions and the results of any verified dimensions
(e.g. pass-through hole gauge).
NOTE Additional guidance can be found in ASTM F2081.

D.5.1.3 Dislodgement force (pre-mounted, balloon expandable endovascular prostheses)

D.5.1.3.1 Purpose

The purpose of the test is to determine the force required to displace the pre-mounted endovascular
prosthesis from its position on the non-expanded balloon.

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D.5.1.3.2 Materials

The following materials apply:

— endovascular system;
— mechanical testing system equipped with a suitable load cell, a constant rate of traverse and suitable
gripping fixture for the balloon catheter;
— a fixture that allows the endovascular prosthesis to be removed from the balloon, while minimizing
interaction between the balloon and the fixture;
— recommended guide wire or equivalent;
— temperature controlled environment (37 ± 2) °C for endovascular systems with material properties
that are sensitive to changes between ambient and physiological temperatures.

D.5.1.3.3 Sampling

Sampling shall be in accordance with D.2. The sampling plan shall include each type of modular
component unless justification is provided for exclusion of a component(s).

D.5.1.3.4 Conditioning

Conditioning shall be in accordance with D.3 and shall include preconditioning and tracking through a
tortuous anatomical model using appropriate accessory devices (e.g. introducer sheath).

D.5.1.3.5 Test method

Develop a test method based on the following steps:

a) insert the guide wire into the endovascular system;
b) secure the endovascular prosthesis in the gripping fixture;
c) attach the tip or the shaft of the delivery system to the other grip of the testing system;
d) activate the test system to separate the endovascular prosthesis from the delivery system using a
constant crosshead speed (e.g. 200 mm/min);
e) record the peak force needed to move the endovascular prosthesis beyond a pre-specified critical
distance (e.g. the margin of the balloon);
f) repeat steps a) to e), using a new sample, reversing the direction of load application (i.e. evaluate
both proximal and distal dislodgement forces).

D.5.1.3.6 Expression of results

Force shall be expressed in Newtons (N).

D.5.1.3.7 Test report

The test report shall be in accordance with D.4 and include the maximum, minimum, mean and standard
deviation of the peak force, for both proximal and distal directions.
NOTE Additional guidance can be found in ASTM F2394.

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D.5.1.4 Force to deploy for self-expanding endovascular prostheses

D.5.1.4.1 Purpose

The purpose of this test is to determine the force to deploy the endovascular prosthesis under simulated
anatomical conditions. All applicable steps of the deployment process should be evaluated.

D.5.1.4.2 Materials

The following materials apply:

— endovascular system;
— accessory devices necessary to accomplish deployment in accordance with the instructions for
use (IFU);
— anatomical model that includes a delivery pathway and a deployment location. The angulation,
tortuosity and diameter of the intended implant location and delivery pathway (including access
pathway) of the model should be representative of a challenging anatomical configuration;
An assessment of the parameters that affect the force to deploy a particular system design shall
be considered in designing an appropriate anatomical model. Literature and patient data are
appropriate sources to identify challenging anatomy. The limits set in the IFU regarding anatomy
are also important to consider when selecting the anatomical model (e.g. neck angulation and
length). Selection of the model material and model geometry should take into consideration the
compliance of the vasculature being represented by the model. The expected response of the in
vivo vessel to the insertion of accessory devices (e.g. guide wire, introducer sheath) and the
endovascular system and the friction associated with the model material should also be considered
in selecting the model material and any test fluid.
— force measuring mechanism (e.g. force gauge, mechanical testing system);
— gripping fixture;
— temperature controlled environment (37 ± 2) °C.

D.5.1.4.3 Sampling

Sampling shall be in accordance with D.2. Endovascular systems to be tested should be representative
of the devices that have the potential for the highest deployment force (e.g. greatest bulk within the
sheath or cover, highest compression ratio). The effect of diameters and lengths should be taken into
consideration in the selection of devices for testing. The sampling plan shall include each type of
modular component unless justification is provided for exclusion of a component(s).

D.5.1.4.4 Conditioning

Conditioning shall be in accordance with D.3.

D.5.1.4.5 Test method

Develop a test method based on the following steps:

a) Prepare the endovascular system per the IFU.
b) Insert the endovascular system into the anatomical model.
c) Attach the deployment mechanism to the load measuring equipment.
d) Allow the device to stabilize at physiological temperatures.

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e) Initiate and complete the deployment, per the IFU at a rate that simulates clinical use while
measuring the force to deploy the prosthesis.
If multiple mechanisms are required for deploying a prosthesis (e.g. tether wire release, sheath pull
back), the force to deploy should be measured for each of these relevant deployment steps.
f) Record any anomalous observations (e.g. buckling) for each test sample.

D.5.1.4.6 Expression of results

For each deployment mechanism, the maximum force required to deploy the prostheses is recorded
in Newtons (N) or Newton-meters (N·m), as appropriate. Record any anomalous observations (e.g.
buckling) for each test sample.

D.5.1.4.7 Test report

Test report shall be in accordance with D.4 and shall include the, maximum, minimum, mean and
standard deviation of the deployment forces and any anomalous observations. The report shall include
a description of and justification for the anatomical model used (e.g. angulation, tortuosity, diameter
and construction material of the model).

D.5.1.5 Simulated use

D.5.1.5.1 Purpose

The purpose of this test is to evaluate the ability to access, deploy and withdraw the endovascular
system, including pushability, flexibility, torquability, trackability and deployment accuracy, using an
anatomical model(s) that is (are) representative of the anatomical variation in the intended patient
population. This test is also intended to evaluate the compatibility of the endovascular system with
accessory devices. Additionally, this test is intended to evaluate the conformability of the deployed
endovascular prosthesis to the vessel wall, positioning (including orientation, if applicable) and absence
of anomalies (e.g. kinks, twists, component separation, non-uniform expansion, prosthesis damage).

D.5.1.5.2 Materials

The following materials apply:

— endovascular system(s), including all components of the implant (e.g. main body, limbs, extenders);
— accessory devices necessary to accomplish deployment in accordance with the instructions for
use (IFU) (e.g. guide wire, introducer sheath, balloons used to achieve adequate apposition of the
prosthesis);
— anatomical model that includes a delivery pathway and a deployment location. The angulation,
tortuosity and diameter of the intended implant location and delivery pathway (including access
pathway) of the model should be based on the expected anatomy in the intended patient population
and can include three-dimensional tortuosity. Multiple models with varied anatomy or materials of
construction might be necessary to sufficiently challenge the relevant characteristics of the device.
Literature and patient data are appropriate sources to identify the expected anatomy. The limits
set in the instructions for use regarding anatomy are also important to consider when selecting the
anatomical model(s) (e.g. neck angulation and length). Selection of the model material and model
geometry(ies) should take into consideration the compliance of the vasculature being represented
by the model. The expected response of the in vivo vessel to the insertion of accessory devices (e.g.
guide wire, introducer sheath) and the endovascular system and the friction associated with the
model material should also be considered in selecting the model material and test fluid.
— fixture capable of delivering water or appropriate fluid at physiological temperature (37 ± 2) °C and
at other clinically relevant physiological conditions (e.g. pulsatile pressures, flow).

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D.5.1.5.3 Sampling

Sampling shall be in accordance with D.2.

D.5.1.5.4 Conditioning

Conditioning shall be in accordance with D.3.

D.5.1.5.5 Test method

Develop a test method based on the following steps:

a) Connect the anatomical model to the fluid system and allow the test system to stabilize at
temperature and other relevant physiological conditions.
b) Following the IFU and using the appropriate accessory devices (e.g. guide wire, introducer sheath),
insert, deliver and deploy the implant, including any modular components, while evaluating the
following:
1) evaluate the ability of the endovascular system to be advanced to, and positioned in, the
targeted deployment location of the anatomical model(s) without compromising the function
of the delivery system. This testing shall include, during advancement of the system, the
evaluation of pushability, flexibility, trackability and, if appropriate, the ability to torque the
system without negatively affecting the ability to deploy. Note any anomalies and their impact
on the performance of the endovascular system;
2) for prostheses requiring rotational orientation for appropriate position, evaluate the ability of
the endovascular system to provide sufficient rotation to the distal (leading) end in order to
position the implant in the targeted deployment location of the anatomical model(s);
3) evaluate the ease and ability to deploy the prosthesis;
4) evaluate the accuracy of deployment;
5) evaluate the ability to withdraw the delivery system and accessory devices from the anatomical
model(s) and note any anomalies, such as prosthesis dislodgment or damage;
6) evaluate the compatibility of the endovascular system with the accessory devices (e.g. guide
wire, introducer sheath) and when appropriate, the compatibility of the accessory devices with
the endovascular system (e.g. balloons used post-deployment).
c) Visually inspect the deployed endovascular prosthesis in the anatomical model. Evaluate and
record the conformability of the endovascular prosthesis to the model vessel wall, positioning
(including orientation, if applicable), absence of anomalies (e.g. kinks, undesired twisting,
component separation, non-uniform expansion, prosthesis damage) and the type and location of
any prosthesis damage or any other anomalies.
d) Visually inspect the delivery system, and record the type and location of any damage or any other
anomalies.
e) Visually inspect the accessory devices, and record the type and location of any clinically relevant
damage or other anomalies.
f) Visually inspect the test fluids for particulates that were generated during the test.

D.5.1.5.6 Expression of results

Results of the assessments shall be expressed descriptively.

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D.5.1.5.7 Test report

The test report shall be in accordance with D.4 and shall include all results and abnormal observations.
The report shall include a description of the anatomical model(s) used and justification of how the
model(s) is representative of the anatomical variation in the intended patient population (i.e. angulation,
tortuosity and diameter). The test fluid viscosity and density and the model material of construction
shall be reported and justified. The pressure and flow conditions shall be justified (i.e. whether or not
these variables were included or controlled during the test). The results for pushability, flexibility,
torquability, trackability, deployment accuracy, conformability of the deployed prosthesis to the vessel
wall and compatibility between the accessory devices and the endovascular system should each be
documented. The type and location of any prosthesis or delivery system damage and any clinically
relevant accessory device damage shall be reported. If visible particle generation is observed during
access, deployment and withdrawal of the endovascular system, this observation should be noted. The
relevance of any observations should be explained in the context of the intended clinical use.

D.5.1.6 Tensile bond strength

D.5.1.6.1 Purpose

The purpose of this test is to determine the bond strength of the joints and/or fixed connections of the
delivery system. The strength of the segments adjacent to the bonds of the delivery system (e.g. sheath,
tubing) shall be evaluated separately or concurrently with the bond strength determination.

D.5.1.6.2 Materials

The following materials apply:

— delivery system or appropriate component joints and/or fixed connections;
— recommended guide wire or equivalent, if appropriate;
— mechanical testing system with a constant rate of traverse, a suitable load cell and appropriate
gripping fixtures;
— temperature controlled environment (37 ± 2) °C, as appropriate.

D.5.1.6.3 Sampling

Sampling shall be in accordance with D.2.

D.5.1.6.4 Conditioning

Conditioning shall be in accordance with D.3. Conditioning of the test samples should include loading,
tracking (access and withdrawal) and deployment. Multiple tracking cycles through an appropriate
anatomical model should be considered. Information regarding an appropriate anatomical model is
provided in D.5.1.5.2. Delivery systems from completed simulated use testing (see D.5.1.5) may be used
for this test.

D.5.1.6.5 Test method

For bonds that will be subjected to physiological temperatures, testing should be performed at
(37 ± 2) °C.
Develop a test method based on the following steps:
a) Insert the delivery system or component over the guide wire, if appropriate.

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b) Using a mechanical testing system with an appropriate crosshead speed (e.g. 200 mm/min), apply
tension to the bonded joint or to a series of bonded joints until a bond breaks or loses functional
integrity.
c) Record the peak force at which failure occurs and describe the type and location of the failure.

D.5.1.6.6 Expression of results

Bond strength shall be expressed in Newtons (N).

D.5.1.6.7 Test report

The test report shall be in accordance with D.4 and shall include the type and location of the failure and
the maximum, minimum, mean and standard deviation of the bond strength(s).
The acceptance criteria for the bond strength(s) should take into consideration the expected
forces applied to the delivery system during clinical use [e.g. tracking (access and withdrawal) and
deployment].

D.5.1.7 Torsional bond strength

D.5.1.7.1 Purpose

The purpose of this test is to determine the torque required to cause failure of the joints and/or fixed
connections in the appropriate segments of the delivery system (i.e. joints and/or fixed connections that
are subjected to torsion during clinical use). The strength of the segments adjacent to the bonds of the
delivery system (e.g. sheath, tubing) shall be evaluated separately or concurrently with the torsional
bond strength determination.

D.5.1.7.2 Materials

The following materials apply:

— delivery system or appropriate component joints and/or fixed connections;
— recommended guide wire or equivalent, if appropriate;
— torque testing system with a suitable torque gauge;
— temperature controlled environment (37 ± 2) °C, as appropriate.

D.5.1.7.3 Sampling

Sampling shall be in accordance with D.2.

D.5.1.7.4 Conditioning

Conditioning shall be in accordance with D.3. Conditioning of the test samples should include loading,
tracking (access and withdrawal) and deployment. Multiple tracking cycles through an appropriate
anatomical model should be considered. Information regarding an appropriate anatomical model is
provided in D.5.1.5.2. Delivery systems from completed simulated use testing (see D.5.1.5) may be used
for this test.

D.5.1.7.5 Test method

For bonds that will be subjected to physiological temperatures, testing should be performed at
(37 ± 2) °C.

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Develop a test method based on the following steps:

a) Insert the delivery system or component over the guide wire, if appropriate.
b) Affix one end of the test sample in a clamping apparatus.
c) Affix other end of the test sample to the torque gauge. The test gauge length shall be long enough to
avoid influence of the clamping apparatus and short enough to ensure uniform torsional loading.
d) Apply a torque at a rate characteristic of that used in typical clinical use to one end of the sample
until the joint and/or delivery system breaks or loses functional integrity.
e) Record the torque at which failure occurs and the failure mode and location.

D.5.1.7.6 Expression of results

Torsional bond strength shall be expressed in Newton-meters (N·m).

D.5.1.7.7 Test report

The test report shall be in accordance with D.4 and shall include the mode and location of the failure
and the maximum, minimum, mean and standard deviation of the torsional bond strength.
The results shall be evaluated in relation to the torque necessary to access, deploy and withdraw
the system.

D.5.1.8 Haemostasis

D.5.1.8.1 Purpose

The purpose of this test is to evaluate the ability of any haemostatic seal or valve in the delivery system
to minimize leakage of blood.

D.5.1.8.2 Materials

The following materials apply:

— endovascular system;
— accessory devices necessary to accomplish deployment in accordance with the instructions for
use (IFU);
— pressurized fluid fixture capable of delivering water or an appropriate fluid, at physiological
temperature (37 ± 2) °C and appropriate pressure (e.g. 100 mmHg);
— reservoir for collecting and measuring the total fluid leakage from the endovascular system to a
justified minimum accuracy (e.g. ±5 ml);
— timer with an accuracy of ±1 s.

D.5.1.8.3 Sampling

Sampling shall be in accordance with D.2.

D.5.1.8.4 Conditioning

Conditioning shall be in accordance with D.3.

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D.5.1.8.5 Test method

Develop a test method based on the following steps:

a) Prepare the fixture for receipt of the endovascular system. For systems that do not have integral
sheaths, place the appropriate accessory devices (e.g. guide wire, introducer sheath) in the fixture.
b) Prepare and insert the endovascular system into the fixture.
c) Place the reservoir(s) to collect the fluid leakage from any seal or valve in the delivery system and
start timing.
Leakage between the fixture and the introducer sheath should not be included. If appropriate,
leakage between the introducer sheath and the endovascular system may be included.
d) Stop fluid collection and timer. The duration of test should be adequate to determine the leakage
through the seal or valve.
e) Record the amount of fluid leakage and the elapsed time over which leakage occurred.
f) Repeat step c) through step e) for any devices intended to be inserted through the haemostatic
valve of the endovascular system (e.g. additional delivery system, balloon, wire).

D.5.1.8.6 Expression of results

The leakage rate(s) shall be expressed in millilitres per minute (ml/min).

D.5.1.8.7 Test report

The test report shall be in accordance with D.4 and include the maximum, minimum, mean and standard
deviation of each leakage rate. The test timing, pressure and fluid used shall be reported. If blood or
simulated blood is used, the density, viscosity or treatments (e.g. anti-coagulants) shall be identified.
NOTE Guidance for introducer sheaths can be found in ISO 11070.

D.5.1.9 Visibility

D.5.1.9.1 Purpose

The purpose of this test is to evaluate the ability to visualize the endovascular system and endovascular
prosthesis using the imaging techniques specified in the instructions for use (IFU).

D.5.1.9.2 Materials

The following materials apply:

— endovascular system;
— accessory devices necessary to accomplish deployment in accordance with the IFU;
— phantom tissue model, or equivalent (e.g. large animal model);
— imaging machine (e.g. fluoroscopy) capable of operating at clinically relevant power levels.
Visibility is significantly affected by variations in equipment and parameter settings. In the selection of
the equipment used for this evaluation, consideration should be given to this variability.

D.5.1.9.3 Sampling

Sampling shall be in accordance with D.2.

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D.5.1.9.4 Conditioning

Conditioning shall be in accordance with D.3.

D.5.1.9.5 Test method

Develop a test method based on the following steps:

a) Position the endovascular system in the phantom tissue model.
b) Position the model relative to the imaging machine to simulate clinical conditions.
c) Use the imaging machine to visualize the endovascular system and any identification markers.
d) Evaluate the images for ease of visibility. For example, the degree of visibility may be assessed
by locating the exact ends, orientation of critical points and/or parts of the endovascular system.
Alternatively, the degree of visibility may be compared to a specified material or device with known
visibility.
e) Repeat step a) through step d) to evaluate the prosthesis and the delivery system during deployment
and withdrawal, and the prosthesis after withdrawal of the delivery system.

D.5.1.9.6 Expression of results

Results of the assessments shall be expressed descriptively, with representative images as appropriate.

D.5.1.9.7 Test report

The test report shall be in accordance with D.4 and shall include the assessment of visibility for all
applicable components at the various stages of the testing. Describe the results of the assessments
and/or include visual results (e.g. representative fluoroscopic images). The test report shall also include
the manufacturer and model of the imaging equipment, the relevant imaging parameters and details of
the phantom tissue model.
NOTE Additional information can be found in ASTM F640.

D.5.2 Implant (endovascular prosthesis)

D.5.2.1 Corrosion assessment

D.5.2.1.1 Purpose

The purpose of this assessment is to evaluate the susceptibility of the metallic materials of the
endovascular prosthesis to corrosion.
NOTE This annex does not include specific methodology for corrosion testing. Guidance is provided
regarding the assessment of corrosion using various sources (e.g. literature, historical clinical data) and through
reference to other standards.

D.5.2.1.2 Materials for corrosion testing

The following materials apply:

— endovascular prosthesis or appropriate test samples of the prosthesis (e.g. segments, sections,
components, subassemblies) that have undergone actual or simulated manufacturing processes.
Test samples shall be appropriate to the type of corrosion under evaluation (e.g. crevice, pitting,
fretting, galvanic);
— materials as specified in the test methods selected for this evaluation;

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— reference samples, as appropriate.

D.5.2.1.3 Sampling for corrosion testing

Sampling shall be in accordance with D.2.

D.5.2.1.4 Conditioning for corrosion testing

Conditioning shall be in accordance with D.3 and shall include actual or simulated loading and
deployment.

D.5.2.1.5 Assessment

The susceptibility of the metallic materials of the prosthesis to corrosion should be assessed.
Corrosion assessment includes, but is not limited to, evaluation of test results, review of literature and
consideration of the historical clinical performance of the material(s) under assessment. Guidance on
corrosion assessment may be found from a variety of sources (e.g. literature, text books, standards,
regulatory guidance documents).
The following is a partial list of references regarding corrosion terminology, equipment, test procedures
and methods:
— ISO 17475, Corrosion of metals and alloys — Electrochemical test methods — Guidelines for conducting
potentiostatic and potentiodynamic polarization measurements
— ISO 16429, Implants for surgery — Measurements of open-circuit potential to assess corrosion behaviour
of metallic implantable materials and medical devices over extended time periods
— ASTM F746, Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
— ASTM F2129, Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements
to Determine the Corrosion Susceptibility of Small Implant Devices
— ASTM F3044, Test Method for Standard Test Method for Evaluating the Potential for Galvanic Corrosion
for Medical Implants
— ASTM G5, Standard reference test method for making potentiostatic and Potentiodynamic Anodic
Polarization Measurements
— ASTM G61, Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements
for Localized Corrosion Susceptibility of Iron-, Nickel-, or Cobalt-Based Alloys
— ASTM G71, Standard Guide for Conducting and Evaluating Galvanic Corrosion Tests in Electrolytes
— ASTM G102, Standard Practice for Calculation of Corrosion Rates and Related Information from
Electrochemical Measurements

D.5.2.1.6 Expression of results for corrosion testing

Test data shall be expressed in units appropriate to the methods selected.

D.5.2.1.7 Test report

The test report shall be in accordance with D.4 and shall include the complete corrosion assessment,
including a summary of all test data, analyses and referenced information, comparisons to applicable
controls, any appropriate comparison between in vivo and in vitro performance and conclusions
regarding the anticipated corrosion resistance of the metallic materials of the endovascular prosthesis.
Applicable requirements indicated in the guidance documents used for testing should also be included.

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D.5.2.2 Fatigue and durability — Computational analyses

D.5.2.2.1 Purpose

The purpose of the computational analyses is to calculate the magnitude and location of the maximum
stresses and/or strains for each appropriate loading scenario based upon the intended clinical
application and device design. Appropriate computational analysis tools, such as finite element analysis
(FEA), can be used to calculate the stresses and/or strains. The stresses and/or strains can be compared
to material characteristics to calculate the fatigue safety factor.
Computational analyses may also be used to establish appropriate test conditions and to select test
articles for fatigue and durability testing.

D.5.2.2.2 Model inputs and tools

The following model inputs and tools apply:

— structural design of the endovascular prosthesis and, if appropriate, a representation of the in vivo
environment (e.g. blood vessel);
— material properties (e.g. modulus, fatigue limit, vessel compliance) and constitutive models (e.g.
linear elastic) for all materials under evaluation;
— the information needed to establish boundary conditions related to manufacturing (e.g. compressed
diameter required to achieve delivery system profile), deployment (e.g. balloon expansion diameter or
implant diameter) and, if appropriate, interaction between the prosthesis and the surrounding tissue;
— the information needed to establish boundary conditions (e.g. constraints and loads) that are
representative of the intended clinical use (e.g. vessel diameters, deformation, angulation,
tortuosity);
— appropriate modelling tools, such as finite element analysis and computer aided design software to
model the endovascular prosthesis and, if appropriate, the in vivo environment (e.g. blood vessel).

D.5.2.2.3 Analysis

The analyses shall be performed on the sizes and configurations necessary to ensure an adequate
evaluation of the prosthesis.
Perform computational analyses based on the following steps:
a) Establish the purpose of each computational analysis.
1) Establish the purpose of each computational model analysis. For example, the computational
analysis may be used to identify the prosthesis size and configuration that is expected to
perform with the lowest fatigue safety factor.
2) Select computational software with the capabilities to perform the analysis.
b) Define the model geometry.
1) Identify the sizes and configurations of the prostheses to be evaluated.
2) Establish the prosthesis geometry and, if appropriate, mock or diseased vessel geometry.
The geometry should be representative of the finished product. Analysis may be limited to
segments of the prosthesis, and/or vessel, with appropriate justification. Consideration shall
be given to the allowed variability of the dimensions when selecting the geometry for analysis.

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3) All appropriate deformation modes should be considered in selecting the extent of the
prosthesis to be modelled or when applying symmetry assumptions.
c) Establish the material properties.
Determine the properties of the materials of the finished prosthesis necessary to conduct the
analysis. If appropriate, establish the material properties for the representative vessel.
d) Define the constitutive model.
1) For each material in the analysis, determine the appropriate constitutive model (i.e. the
relationship between stress and strain) such as superelasticity, hyperelasticity and plasticity.
The material properties that are used to develop the constitutive models should represent the
final, processed materials (e.g. final heat treatment).
2) Confirm that the constitutive model(s) represents the behaviour of the material within the
applicable stress or strain range using an appropriate test method(s) (e.g. tensile, bending).
e) Create the finite element mesh.
Create a mesh and specify the element type(s), shape(s) and formulation(s) (e.g. shape function) to
model the prosthesis and, if appropriate, the representative vessel.
f) Apply the constraints to the mesh.
g) Apply the loading conditions.
1) Apply the loading conditions to represent delivery system loading (e.g. compressed diameter
required to achieve the delivery system profile) prosthesis deployment (e.g. balloon expansion
diameter, implant diameter), and recoil, if applicable.
2) Apply the representative loading conditions (e.g. cyclic deformation, cyclic pressure) that the
prosthesis is expected to experience in vivo.
h) Apply solution methodology and execute the analysis.
1) Select the appropriate solution techniques and tolerances for the equation(s) being solved.
2) Incorporate any additional boundary conditions necessary to ensure model stability. It is
important to ensure that the applied boundary conditions do not over-constrain and/or do not
add unintended loadings, rotations or contact.
i) Verify the solution.
Conduct a mesh sensitivity analysis to demonstrate that further mesh refinement does not
significantly change the computational results (e.g. the maximum strain does not change
significantly when additional elements are used).
j) Validate the computational model.
Obtain test data to allow comparison of the appropriate output(s) of the model to the physical
behaviour of the prosthesis.
k) Analyse results.
1) Compute the appropriate stress or strain quantities (e.g. principal stresses, equivalent strains).
2) Calculate fatigue safety factors using the appropriate failure criteria (e.g. constant life diagram).
Identify the location associated with the lowest fatigue safety factor (e.g. high stress/strain
regions).

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D.5.2.2.4 Expression of results

Stress shall be expressed in megapascals (MPa). Strain shall be expressed as a percentage (%). Locations
of critical stresses and strains should be depicted in colour figures with legends. Diagrams for fatigue
analysis shall be provided (e.g. constant life, Goodman analyses, etc.).

D.5.2.2.5 Report
NOTE The computational analysis report is intentionally different from the standard test reports
described in D.4.

The report shall include the following:

a) Background and purpose
1) Provide a brief device description and the intended use environment.
2) State the purpose of each analysis.
b) Geometry
1) Report the sizes and configurations of the prostheses selected for evaluation.
2) Provide diagrams and a brief description of the model(s).
3) Provide a justification for the sizes and configurations of the prostheses selected for evaluation.
4) If only a portion of the prosthesis was modelled, provide a justification for the geometry
analysed (e.g. the use of symmetry).
5) Provide a justification for how the model geometry is representative of the finished product
and, if appropriate, the mock or diseased vessel (e.g. size, disease state).
6) Report the dimensions selected in the context of the expected variability.
c) Material properties
1) List all of the materials in the model and report the relevant material property values (e.g.
modulus, yield strength, fatigue limit).
2) Provide and justify the source of the material properties (e.g. literature, test data and
conditions) for the prosthesis and, if appropriate, for the representative vessel.
3) Provide a justification for why the material properties are representative of the final, processed
material (e.g. final heat treatment) in the intended in vivo environment (e.g. 37 °C). If applicable,
describe tests conducted to determine the material properties.
d) Constitutive model
1) For each material, provide the relationship between stress and strain (i.e. constitutive model)
including a graphical representation and/or the associated equations.
2) For each material, discuss how the constitutive model captures the material behaviour (e.g.
loading, unloading, plastic deformation).
3) Provide a justification for the assumptions in the constitutive model used to represent each
material.
4) Provide a summary of the methodology and data for any testing conducted to support the
constitutive model.

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e) Mesh
1) Describe the element type, shape and formulation for the mesh used in the analysis.
2) Provide a representative image of the mesh in the areas of high stress/strain.
3) Provide a justification for why the elements selected adequately represent the spatial
distribution of the stress/strain under the prescribed loading.
f) Constraints
1) Report the boundary conditions (e.g. rigid cylinder for vessel, fixed degrees of freedom),
including a graphical representation if appropriate.
2) Provide a justification for the boundary conditions used to restrict motion of the model or to
isolate specific deformations.
g) Loading conditions
1) Report the loading parameters (e.g. location, magnitude and direction of loading, number of
cycles) and the sequence of the loads applied to the model to represent delivery system loading,
prosthesis deployment and recoil, if appropriate.
2) Report the loading conditions (e.g. cyclic deformation, cyclic pressure) applied to the model to
represent the deformation(s) or load(s) the prosthesis is expected to experience in vivo.
3) Provide justification that the delivery system loading and prosthesis deployment simulation are
representative of actual delivery system loading (e.g. compressed diameter required to achieve
the delivery system profile) in accordance with manufacturing and prosthesis deployment in
accordance with the IFU.
4) Provide a justification for the values used for the expected in vivo loading conditions.
h) Solution methodology
1) Report the equation solution techniques and tolerances. Describe the software package and
any user subroutines that were implemented.
2) Provide a justification for any additional boundary conditions used to enhance model stability.
i) Solution verification
1) Report the results of the mesh sensitivity analysis, demonstrating that further mesh refinement
does not significantly change the computational results (e.g. the maximum strain does not
change significantly when additional elements are used).
2) Provide a justification for the computational result (e.g. maximum strain) used to establish the
adequacy of the mesh density.
j) Validation
1) Provide an adequate description of the test method (e.g. radial outward force) used to assess
the ability of the computational model to adequately predict the behaviour of the prosthesis.
This description may include illustrations to show similarities between the model and the test
article in the fixture.
2) Provide a comparison of the test results to the values predicted by the computational model
over a region relevant to the analysis objectives. Provide an assessment of the significance of
any relevant differences between the measured and predicted values.

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3) Provide a justification for the mode of loading used to assess the ability of the computational
analysis to adequately predict the behaviour of the prosthesis.
k) Results
For each computational analysis, report the magnitude and illustrate the physical location(s) of the
relevant quantitative results (e.g. maximum principal stresses, mean and alternating equivalent
strain, fatigue safety factors).
l) Discussion/Conclusions
1) Discuss the results in the context of the stated purpose of the computational model (e.g.
identifying the prosthesis configuration and size with, and the location of, the lowest fatigue
safety factor, assessing the acceptability of the fatigue safety factors), including any limitations
and conservative modelling conditions.
2) When applicable, discuss the implications of the computational analysis with respect to
related testing. For example, explain how the computational analysis complements accelerated
durability testing conclusions.

D.5.2.3 Fatigue and durability tests — in vitro testing

Device durability may be evaluated in separate individual tests, tests that apply multiple sequential
deformation modes, or tests that apply simultaneous deformation modes. When combining deformation
modes under a single test, the relative rate of occurrence of the deformation modes should be considered
in developing appropriate test methods, particularly with accelerated testing.

D.5.2.3.1 General

The information included under this subclause are applicable to radial fatigue and durability, active
fixation fatigue and durability, axial fatigue and durability, bending fatigue and durability and torsional
fatigue and durability that follow in D.5.2.3.2 to D.5.2.3.6. Specific considerations for the development
of test methods are included in the individual clauses.
For the purpose of this subclause, displacement is defined as the movement of a test fixture, a test
article or mock artery (e.g. diametrical, linear, rotational) in response to the action of a test apparatus.
Deformation is defined as the change in shape of a test article or endovascular prosthesis in response to
a displacement(s) or an applied load(s).
NOTE Additional information can be found in ASTM F2477 and ASTM F2942.

D.5.2.3.1.1 Purpose

Fatigue and durability testing is intended to evaluate aspects of the long-term structural integrity of
the endovascular prosthesis under cyclic loading conditions that represent the in vivo environment.
Appropriate test methods should be developed to simulate physiological deformations of the
endovascular prosthesis. These test methods should describe how to attain deformations of the test
article through the application of forces and/or displacements to the test fixture or a mock vessel.
The long-term integrity of active fixation components (e.g. hooks, barbs, anchors) should also be
evaluated. Information to aid in the development of an appropriate test method is presented below.
Potential failure modes that can be evaluated in these tests include: stent fracture, fracture of active
fixation components, detachment of the stent from the graft material, tearing or other failure modes of
the fabric or covering, and wear or abrasion between prosthesis components.
The fatigue and durability tests are not intended to fully evaluate potential failure modes related to
corrosion, wear between the prosthesis and the recipient vessel or prosthesis migration. Consideration
should be given as to whether such observations during testing indicate an increased potential for
these failure modes to occur clinically.

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D.5.2.3.1.2 Materials

The following materials apply:

— endovascular system;
NOTE This test is not designed to evaluate the entire system; however, the system is required to deploy the
prosthesis that is under test.

— accessory devices necessary to accomplish deployment in accordance with the instructions for
use (IFU) (e.g. guide wire, introducer sheath, balloons used to achieve adequate apposition of the
prosthesis);
— if applicable, a mock artery with a diameter and properties appropriate to enable simulation of the
loading mode under study:
— appropriately sized to represent the vessel diameter for the loading conditions under test;
— constructed of a material (e.g. silicone) capable of maintaining consistent deformation of the
test article under cyclic loading, without creating unwanted deformation of the test article;
— capable of withstanding the test conditions at the test frequency and temperature for the
duration of the test;
— designed and/or modified to minimize test article migration;
— fatigue test system capable of applying cyclic loads and/or displacement to the test article;
— measurement system(s) (e.g. load cell, strain gauge, high speed camera) capable of quantifying
appropriate loads, displacements and/or deformations;
— cycle counting system for measuring the number of cycles applied to the test article;
— fluid fixture capable of maintaining phosphate buffered saline (PBS) (unless testing in a
different fluid can be justified) at physiological temperature (37 ± 2) °C;
— inspection equipment [e.g. light microscope, lighted magnifying glass, high resolution X-ray,
scanning electron microscopy (SEM)].

D.5.2.3.1.3 Sampling

Sampling shall be in accordance with D.2.

Sampling shall allow for the evaluation of the structural integrity of all relevant parts of the prosthesis
and contact areas between components.
The endovascular prosthesis size(s) with the greatest potential for fatigue failure shall be identified
and justified using computational modelling (e.g. finite element analysis), engineering analysis and/or
clinical data. Alternatively, samples representing the range of sizes may be chosen for testing.
Segments or portions of the complete prosthesis may be used as the test article if appropriately justified.

D.5.2.3.1.4 Conditioning

Conditioning shall be in accordance with D.3.

The endovascular system should be tracked through an anatomical model prior to fatigue and durability
testing unless appropriate justification is provided.

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D.5.2.3.1.5 Test method

This subclause includes general considerations for the development of all types of fatigue and
durability tests.
a) Define test conditions
1) Establish loading conditions
The effect of the endovascular prosthesis on the overall deformation expected in vivo should
be considered when establishing the loading conditions. The direction and magnitude of the
applied displacement or force should be justified based on physiologically relevant data (e.g.
literature, clinical data) for the specific anatomical location, patient age or condition being
treated. Computational modelling may be used with the physiologically relevant data to
determine the appropriate loading conditions.
2) Mock artery
There is no general guidance beyond those included in the general materials (see D.5.2.3.1.2).
See a), 2) of the individual fatigue and durability test methods.
3) Test frequency
The test frequency shall be selected to maintain the test article deformation within the pre-
defined limits for the duration of the test and to avoid undesirable harmonics, localized heating
of the prosthesis and rate-dependent effects on material properties.
4) Displacement conditions/control
The gripping technique, slip between the mock artery (if used) and the test article or dynamic
forces may result in deformations other than intended during testing. Establish the method to
control displacement or the application of force during testing and verify that each test article
achieves the intended deformation during the cyclic loading at the test frequency over the
duration of the test.
b) Setup
1) Either deploy the test article according to the IFU directly into the test fixture or deploy the
endovascular prosthesis according to the IFU and secure the test article (i.e. either the complete
prosthesis or a segment or portion of the prosthesis) to the test fixture. If appropriate, deploy
additional overlapped components.
2) Inspect the test article(s) using appropriate visual aids and record the location and severity of
any anomalies (e.g. in-folding of graft material, non-uniform prosthesis expansion).
3) Allow the test articles to reach the pre-defined test temperature before initiating the test.
c) Testing
1) After initiation of testing at periodic intervals, monitor the test conditions and equipment
operation to ensure that the test article does not migrate and experiences the intended
displacements or forces. Because the relationship between the intended displacements or
forces and test article deformation might change over time, it might be necessary to verify that
the test article is deforming as intended. The methodology to verify that the displacements
and/or deformations are as intended shall be described in the test method.
If appropriate, stop the test at periodic intervals for inspection of the test article(s).
Removing the test article from a mock artery for the periodic inspection is not recommended.
However, if removing the test article from a mock artery is necessary, care shall be taken to
remove and re-deploy in a manner that minimizes the effect on the test article.

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2) Termination
Terminate the test after the desired number of cycles has been achieved or a pre-specified
endpoint has been observed.
3) Post-test inspection
Carefully remove the test articles from the test apparatus and mock artery, if applicable.
Completely visually inspect each test article for evidence of macroscopic damage. If anomalies
are identified, if fractures cannot be visually identified due to the size or design of the
endovascular prosthesis or if additional evaluation of regions of interest (e.g. potential areas
of high stress/strain or wear) is needed, use appropriate methodologies (e.g. light microscopy,
scanning electron microscopy, high resolution X-ray) to further inspect for evidence of damage.
Identify and document the presence and location of any anomalies, including the following:
— pre-specified failures modes under evaluation in the test, such as stent fracture, fracture
of active fixation components, detachment of the stent from the graft material, tearing or
other failure modes of the fabric or covering (e.g. graft wear holes) and significant wear
between prosthesis components;
— additional observations, such as perforation, suture breaks and suture hole elongation;
— failure modes that may be related to corrosion, wear between the prosthesis and the
recipient vessel, or prosthesis migration. Consideration should be given as to whether such
observations indicate an increased potential for these failure modes to appear clinically.
SEM images can be taken of fracture surfaces and fracture locations to characterize the nature and
origin of the fracture. When evaluating fractures, consider the potential for artefactual stent fracture
related to the test apparatus (e.g. gripping method).

D.5.2.3.1.6 Expression of results

There is no general guidance. See the expression of results section of the individual fatigue and
durability test methods.

D.5.2.3.1.7 Test report

The test report should be in accordance with D.4. The intended and measured displacements and/or
deformations shall be reported.
Results of all inspections, including the cycle count at which the inspections took place and the number
and location of any observed anomalies shall be reported. The test report should include a discussion on
the potential causes (e.g. fatigue failure, material inclusion, pre-existing sample damage, mock artery
friction) and clinical relevance of the observations. Results should be considered and interpreted in
relation to any applicable in vivo data.

D.5.2.3.2 Radial fatigue and durability

D.5.2.3.2.1 Purpose

The purpose of this test is to evaluate the long-term structural integrity of the endovascular prosthesis
when subjected to cyclic radial loading conditions.

D.5.2.3.2.2 Materials

Refer to the materials listed in the general materials (see D.5.2.3.1.2), including the mock artery.

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D.5.2.3.2.3 Sampling

Refer to the information in the general sampling (see D.5.2.3.1.3).

D.5.2.3.2.4 Conditioning

Refer to the information in the general conditioning (see D.5.2.3.1.4).

D.5.2.3.2.5 Test method

Refer to the information in the general test method (see D.5.2.3.1.5) with the following.
This test method describes a radial cyclic fatigue and durability test that subjects the test article to a
specified amount of cyclic radial deformation. Testing is performed using a mock artery and fatigue
tester that induces an expected physiologic radial deformation of the test article. Each test article is
inspected periodically during the test for the occurrence of strut fracture, graft material holes and
other aspects of structural integrity.
a) Define test conditions
1) Establish loading conditions
Refer to the information in the general test method, establish loading conditions [D.5.2.3.1.5,
item a) 1)] with the following.
The loading conditions of the test, that is, the intended mean and alternating diameters of the
test article, are based on the expected clinical vascular pressures, the in vivo dynamic radial
compliance of the target vessel,and the radial stiffness of the prosthesis. Force equilibrium
models, finite element analysis or experimental evaluation can be used to establish the target
mean and alternating diameters.
Definitions of compliance reported in the literature vary. Dynamic radial compliance
should be expressed as a percentage of the diameter change per 100 mmHg and defined per
ISO 7198:2016, A.5.9.
%Compliance = (Dp2 − Dp1) × 104/[Dp1(p2 − p1)] (D.2)

where

Dp1 is the inner diameter at the pressure of p1;

Dp2 is the inner diameter at the pressure of p2;

p1 is the lower pressure value (diastolic), in mmHg;

p2 is the higher pressure value (systolic), in mmHg.

2) Mock artery
Refer to the information regarding the mock artery in the general materials (see D.5.2.3.1.2)
with the following.
The mock artery should allow displacement of the test article at the intended amplitude around
the intended mean diameter, at the test frequency and temperature, for the duration of the test.
NOTE Mock artery diameter, wall thickness and compliance can be appreciably affected by the tube-
mounting operation.

3) Test frequency

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Refer to the information in the general test method, test frequency section [D.5.2.3.1.5,
item a) 3)].
4) Displacement conditions/control
Refer to the information in the general test method, displacement conditions/control
[D.5.2.3.1.5, item a) 4)] with the following.
Establish the method to control radial displacement during testing. Verify that the test article
achieves the intended deformation during the cyclic loading at the test frequency using a
representative sample. The results of this verification activity should be used to establish the
procedure for controlling the displacement of the test articles. For example, if it can be shown
that the outside diameter of the mock artery as measured by a laser micrometer correlates
with the intended deformation of the prosthesis (see D.6), then this may be used to control the
applied displacement during testing.
There are important considerations for controlling radial displacement during testing that
should be identified and addressed in establishing the procedures for controlling displacement.
For example, apposition of the test article to the mock artery should be maintained.
b) Setup
Refer to the information in the general test method, set up [D.5.2.3.1.5, items b) 1) to 3)].
c) Testing
Refer to the information in the general test method, testing [D.5.2.3.1.5, item c)] with the following.
1) Set the frequency to the established rate and adjust the test system to achieve the intended
mean and alternating diameters of the mock artery or test article. Verify that the test article
deformations are as intended. After mean and alternating diameter targets are achieved, begin
counting the cycles.
2) Verify the mean and alternating diameters at regular time intervals to ensure that the target
values are maintained. Adjust the test system as necessary to maintain the desired operational
target. The location and method for measuring diameter and deformation should be specified
and justified.
d) Termination
Refer to the information in the general test method, termination [D.5.2.3.1.5, item d)].
e) Post-test inspection
Refer to the information in the general test method, post-test inspection [D.5.2.3.1.5, item e)].

D.5.2.3.2.6 Expression of results

The test frequency shall be expressed in cycles per second (Hz). All pressures shall be expressed in
kilopascals (kPa) or millimetres of mercury (mmHg). Diameters shall be expressed in millimetres
(mm). Radial displacement shall be expressed in millimetres (mm) or as the percent change in diameter
(%) of the test articles and is calculated by 100(ΔD/Ddiastolic) where D refers to the outer diameter of
the test articles. The compliance is expressed as a percentage of the diameter change per 100 mmHg
(%/100 mmHg).

D.5.2.3.2.7 Test report

Refer to the information in the general test method, test report (see D.5.2.3.1.7) with the following:
The intended and measured radial displacements of the test article shall be reported.

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D.5.2.3.3 Active fixation fatigue and durability

D.5.2.3.3.1 Purpose

The purpose of this test is to evaluate the long-term structural integrity of the securement of the active
fixation components (e.g. barbs, hooks, pins) to the attachment system (e.g. proximal stent) and the
securement of the attachment system to the endovascular prosthesis body when subjected to cyclic
loading conditions, appropriate for the device design and intended clinical use.
NOTE The evaluation of the securement of the active fixation components to the attachment system can
be conducted separately from the evaluation of the securement of the attachment system to the endovascular
prosthesis body.

D.5.2.3.3.2 Materials

Refer to the materials listed in the general materials (see D.5.2.3.1.2).

D.5.2.3.3.3 Sampling

Refer to the information in the general sampling (see D.5.2.3.1.3) with the following:
The number of active fixation components and the total load on these components may vary with
endovascular prosthesis size. The load on each active fixation component shall be considered when
identifying the endovascular prosthesis size with the greatest potential for fatigue failure of the active
fixation component. The endovascular prosthesis size selection can be justified using computational
modelling (e.g. finite element analysis), engineering analysis and/or clinical data.
The number of connections between the attachment system and endovascular prosthesis body and
the total load on these connections may vary with endovascular prosthesis size. The load on each
connection shall be considered when identifying the endovascular prosthesis size with the greatest
potential for fatigue failure of the connection between the attachment system and the endovascular
prosthesis body. The endovascular prosthesis size selection can be justified using computational
modelling (e.g. finite element analysis), engineering analysis and/or clinical data.

D.5.2.3.3.4 Conditioning

Refer to the information in the general conditioning (see D.5.2.3.1.4).

D.5.2.3.3.5 Test method

Refer to the information in the general test method (see D.5.2.3.1.5) with the following.
This test method describes a fatigue and durability test that subjects the active fixation components of
the endovascular prosthesis and the connections between the attachment system to the endovascular
prosthesis body to a specified number of cyclic loads. The direction of loading (e.g. axial) is selected
and applied resulting in a minimum and a maximum load applied to the test article. Testing is
performed with a fatigue tester that induces an expected physiologic loading to the test article and
can be performed with or without a mock artery. Each test article is monitored during the test for the
occurrence of component fracture, separation, strut fracture, graft tears, suture breaks and other
aspects of structural integrity.
a) Define test conditions
1) Establish loading condition
Refer to the information in the general test method, establish loading conditions [D.5.2.3.1.5,
item a) 1)] with the following:
— the loading conditions of the test, that is, the intended displacement of or force applied
to the test article are based on the expected clinical vascular pressures, diameter of the

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vessel, the number of active fixation components and the number of connections between
the attachment system to the endovascular prosthesis body. The load applied to each
fixation component and/or the connections can also be affected by vessel angulation and
the presence of calcification, resulting in non-uniform engagement of the active fixation
components around the circumference of vessel. Force equilibrium models, finite element
analysis or experimental evaluation can be used to establish the target minimum and
maximum forces or displacements;
— determine the location(s) along the active fixation component (e.g. tip, distributed along the
length) where the load will be applied. The location chosen for testing should be justified.
2) Mock artery (if applicable)
Refer to the information regarding the mock artery in the general materials (see D.5.2.3.1.2)
with the following:
— the mock artery may or may not have a physiologically relevant compliance;
— the wall thickness of the mock artery should be appropriate to allow for engagement and
loading of the active fixation component in order to obtain the desired deformation of the
test article.
b) Test frequency
Refer to the information in the general test method, test frequency [D.5.2.3.1.5, item a) 3)].
c) Displacement conditions/control
Refer to the information in the general test method, displacement conditions/control [D.5.2.3.1.5,
item a) 4)].
d) Setup
Refer to the information in the general test method, set up [D.5.2.3.1.5, items b) 1) to 3)] with the
following.
Ensure that the locations of contact between the test fixture or mock artery and the fixation
component match with the intended contact or loading location.
e) Testing
Refer to the information in the general test method, testing [D.5.2.3.1.5, item c)] with the following.
Set the frequency to the established rate and adjust the test system to achieve the intended
minimum and maximum displacement of, or forces on, the test article. After the displacement or
force targets are achieved, begin counting the cycles.
f) Termination
Refer to the information in the general test method, termination [D.5.2.3.1.5, item d)].
g) Post-test inspection
Refer to the information in the general test method, post-test inspection [D.5.2.3.1.5, item e)].

D.5.2.3.3.6 Expression of results

The test frequency shall be expressed in cycles per second (Hz). Diameters and displacements shall be
expressed in millimetres (mm). Forces shall be express in Newtons (N).

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D.5.2.3.3.7 Test report

Refer to the information in the general test method, test report (see D.5.2.3.1.7) with the following.
The intended and measured minimum and maximum test article displacement or forces shall be
reported.

D.5.2.3.4 Axial fatigue and durability

D.5.2.3.4.1 Purpose

The purpose of this test is to evaluate the long-term structural integrity of the endovascular prosthesis
when subjected to cyclic axial loading conditions appropriate for the device design and intended
clinical use.

D.5.2.3.4.2 Materials

Refer to the materials listed in the general materials (see D.5.2.3.1.2).

D.5.2.3.4.3 Sampling

Refer to the information in the general sampling (see D.5.2.3.1.3).

D.5.2.3.4.4 Conditioning

Refer to the information in the general conditioning (see D.5.2.3.1.4).

D.5.2.3.4.5 Test method

Refer to the information in the general test method (see D.5.2.3.1.5) with the following.
This test method describes an axial cyclic fatigue and durability test that subjects the test article to a
specified amount of cyclic axial displacement. Axial deformation of the test article can be applied by
lengthening, shortening or cycling about a neutral position. Testing is performed with a fatigue tester
that induces an expected physiologic axial deformation of the test article and can be performed with or
without a mock artery. Each test article is inspected periodically during the test for the occurrence of
strut fracture, graft material holes and other aspects of structural integrity.
The test article, with or without a mock artery, can be directly secured to the test fixture with the load
applied directly to the test article or the test article can be deployed within a mock artery and the load
applied to the mock artery with appropriate justification.
a) Define test conditions
1) Establish loading conditions
Refer to the information in the general test method, establish loading conditions [D.5.2.3.1.5,
item a) 1)] with the following:
The loading conditions of the test, that is, the intended minimum and maximum axial lengths
are based on the anticipated clinical lengthening and/or shortening. Force equilibrium models,
finite element analysis or experimental evaluation can be used to establish the target minimum
and maximum lengths.
2) Mock artery (if applicable)
Refer to the information regarding the mock artery in the general materials (see D.5.2.3.1.2)
with the following.
The mock artery may or may not have a physiologically relevant compliance.

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3) Test frequency
Refer to the information in the general test method, test frequency section [D.5.2.3.1.5,
item a) 3)].
4) Displacement conditions/control
Refer to the information in the general test method, displacement conditions/control
[D.5.2.3.1.5, item a) 4)] with the following.
Establish the method to control axial displacement applied during testing. Verify that the test
article achieves the intended deformation during the cyclic loading at the test frequency using
a representative sample. The results of this verification activity should be used to establish
the procedure for controlling the displacement of the test articles. For example, if it can be
shown that the cross head displacement of the axial testing apparatus adequately correlates
with the intended deformation of the prosthesis, then this may be used to control the applied
displacement during testing.
b) Setup
Refer to the information in the general test method, set up [D.5.2.3.1.5, items b) 1) to 3)] with the
following:
1) if a mock artery is used, and axial shortening of the test article is being evaluated, it may be
appropriate to stretch the mock artery before deploying the test article;
2) adjust the test apparatus to yield the desired axial displacement;
3) when calculating percent axial shortening, the following formula should be used:

 L
% AS = 
(
Free − LMin )  × 100 (D.3)
 LFree 
 
where

%AS is the percent axial shortening;

LFree is the initial unsecured length of the test article as measured on the test apparatus;

LMin is the minimum unsecured length of the test article throughout fatigue cycle.
When calculating percent axial lengthening, the following formula should be used:

 L
%AL= 
(
Max − LFree )  × 100 (D.4)
 LFree 
 
where

%AL is the percent axial lengthening;

LMax is the maximum unsecured length of the test article throughout fatigue cycle;

LFree is the initial unsecured length of the test article as measured on the test apparatus.
c) Testing
Refer to the information in the general test method, testing [D.5.2.3.1.5, item c)] with the following:
1) set the frequency to the established rate and adjust the test system to achieve the intended
minimum and maximum test article length. Verify that the test article deformations are as

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intended. After the minimum and maximum test article length targets are achieved, begin
counting the cycles;
2) verify minimum and maximum test article lengths at regular time intervals to ensure that
the target values are maintained. Adjust the system as necessary to maintain the desired
operational target.
d) Termination
Refer to the information in the general test method, termination [D.5.2.3.1.5, item d)].
e) Post-test inspection
Refer to the information in the general test method, post-test inspection [D.5.2.3.1.5, item e)].

D.5.2.3.4.6 Expression of results

The test frequency shall be expressed in cycles per second (Hz). Diameters and displacements shall be
expressed in millimetres (mm). Axial lengthening or shortening shall be expressed as a percentage (%).

D.5.2.3.4.7 Test report

Refer to the information in the general test method, test report (see D.5.2.3.1.7) with the following.
The intended and measured minimum and maximum test article displacement shall be reported.

D.5.2.3.5 Bending fatigue and durability

D.5.2.3.5.1 Purpose

The purpose of this test is to evaluate the long-term structural integrity of the endovascular prosthesis
when subjected to cyclic bending loading conditions appropriate for the device design and intended
clinical use.

D.5.2.3.5.2 Materials

Refer to the materials listed in the general materials (see D.5.2.3.1.2).

D.5.2.3.5.3 Sampling

Refer to the information in the general sampling (see D.5.2.3.1.3).

D.5.2.3.5.4 Conditioning

Refer to the information in the general conditioning (see D.5.2.3.1.4).

D.5.2.3.5.5 Test method

Refer to the information in the general test method (see D.5.2.3.1.5) with the following:
This test method describes bending fatigue and durability testing that subjects the test article to a
specified amount of cyclic bending deformation. Bending deformation of the test article can be applied
using several methods (e.g. column buckling, bend on a mandrel, bend in an arc without a mandrel).
Testing is performed with a fatigue tester that induces an expected physiologic bending deformation
of the test article and can be performed with or without a mock artery. Each test article is inspected
periodically during the test for the occurrence of strut fracture, graft material holes and other aspects
of structural integrity.

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There is no standardized method for evaluating bending durability. An appropriate test method should
be defined based upon prosthesis design and the intended clinical environment. The use of pressure
within the mock artery and/or the test article might be helpful to aid in the reduction of the flattening
of the mock artery and/or the test article lumen. Three potential methods for evaluating bending
durability are provided in this document. An alternative method for evaluating bending fatigue and
durability may be used.
The three methods are as follows.
a) Column buckling
If a mock artery is used, the test article is deployed into the mock artery and the mock artery
is attached to a set of bending fixtures. If a mock artery is not used, the test article is directly
attached to a set of bending fixtures. The bending fixtures are mounted on a machine capable of
using rectilinear motion to impart consistent cyclic bending motion. A minimum and a maximum
bending radius is selected and applied.
b) Bend on a mandrel
This test may be conducted with the test article directly attached to the apparatus or deployed in a
mock artery which is attached to the apparatus. To create the bending action, the test article or the
mock artery with the test article is deflected around a mandrel or deformed between two curved
mating blocks, resulting in the target maximum and minimum radii of curvature.
c) Bend in an arc without a mandrel
To create the bending action, the end of the test article or the mock artery with the test article is moved
in an arc or other defined path, resulting in the maximum and minimum radii of curvature.
a) Define test conditions
1) Loading conditions
Refer to the information in the general test method, establish loading conditions [D.5.2.3.1.5,
item a) 1)] with the following.
The loading conditions of the test, that is, the intended minimum and maximum bending
conditions are based on the anticipated clinical bending deformation. Force equilibrium
models, finite element analysis or experimental evaluation can be used to establish the target
bending deformation.
2) Mock artery (if applicable)
Refer to the information regarding the mock artery in the general materials (see D.5.2.3.1.2)
with the following.
The mock artery may or may not have a physiologically relevant compliance. The mock artery
may be pressurized to aid in reduction of flattening of its lumen.
3) Test frequency.
Refer to the information in the general test method, test frequency [D.5.2.3.1.5, item a) 3)].
4) Displacement conditions/control
Refer to the information in the general test method, displacement conditions/control
[D.5.2.3.1.5, item a) 4)].
b) Setup
Refer to the information in the general test method, set up [D.5.2.3.1.5, items b) 1) to 3)].

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c) Testing
Refer to the information in the general test method, testing [D.5.2.3.1.5, item c)] with the following:
1) set the frequency to the established rate and adjust the test system to achieve the intended
bending conditions. For the selected test apparatus (column buckling, bend on a mandrel or
bend in an arc without a mandrel), verify that the test article deformations are as intended.
After the target bending conditions are achieved, begin counting the cycles;
2) verify the bending deformation at regular time intervals to ensure that the defined values are
maintained. Adjust the system as necessary to maintain the desired operational target.
d) Termination
Refer to the information in the general test method, termination [D.5.2.3.1.5, item d)].
e) Post-test inspection
Refer to the information in the general test method, post-test inspection [D.5.2.3.1.5, item e)].

D.5.2.3.5.6 Expression of results

The test frequency shall be expressed in cycles per second (Hz). Diameters shall be expressed in
millimetres (mm). Bending radius of curvature or displacement of the test article shall be expressed in
millimetres (mm).

D.5.2.3.5.7 Test report

Refer to the information in the general test method, test report (see D.5.2.3.1.7) with the following.
The test article intended and measured displacement or minimum and maximum radii of curvature
shall be reported.

D.5.2.3.6 Torsional fatigue and durability

D.5.2.3.6.1 Purpose

The purpose of this test is to evaluate the long-term structural integrity of the endovascular prosthesis
when subjected to cyclic torsional loading conditions appropriate for the device design and intended
clinical use.

D.5.2.3.6.2 Materials

Refer to the materials listed in the general materials (see D.5.2.3.1.2).

D.5.2.3.6.3 Sampling

Refer to the information in the general sampling (see D.5.2.3.1.3).

D.5.2.3.6.4 Conditioning

Refer to the information in the general conditioning (see D.5.2.3.1.4).

D.5.2.3.6.5 Test method

Refer to the information in the general test method (see D.5.2.3.1.5) with the following.
This test method describes a torsion durability test that subjects the test article to a specified amount
of cyclic torsional deformation. A repeated torsional motion is applied to the test article (i.e. rotation
with respect to the axis of the test article) or applied to a mock artery with the test article.

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To induce cyclic torsion to the prosthesis, the ends of the mock artery in which the test article has been
deployed are attached to an apparatus that cyclically rotates on one end of the mock artery while the
opposite end of the mock artery remains fixed. It is also acceptable to apply cyclic torsion to the test
article by securing both the test article and mock artery or the test article alone to the test apparatus.
The testing apparatus should be adjusted so that the amount of rotation between the mock artery or
test article attachment points is appropriate to induce the desired torsion in the test article. Each test
article is monitored during the test for the occurrence of strut fracture, graft material holes and other
aspects of structural integrity.
a) Define test conditions
1) Loading condition
Refer to the information in the general test method, establish loading conditions [D.5.2.3.1.5,
item a) 1)] with the following.
The loading conditions of the test, that is, the intended minimum and maximum torsional
conditions are based on the anticipated clinical deformation. Force equilibrium models, finite
element analysis or experimental evaluation can be used to establish the target deformation.
2) Mock artery
Refer to the information regarding the mock artery in the general materials (see D.5.2.3.1.2)
with the following.
Localized instability during torsion testing may occur if the wall thickness of the mock artery
is too thin. Thicker-walled tubes may be used in order to obtain the desired deformation of
the endovascular prosthesis. The mock artery may or may not have a physiologically relevant
compliance.
3) Test frequency
Refer to the information in the general test method, test frequency [D.5.2.3.1.5, item a) 3)].
4) Displacement conditions/control
Refer to the information in the general test method, displacement conditions/control
[D.5.2.3.1.5, item a) 4)] with the following.
Establish the method to control torsional displacement applied during testing. Verify that the
test article achieves the intended deformation during the cyclic loading at the test frequency
using a representative sample. The results of this verification activity should be used to
establish the procedure for controlling the displacement of the test articles. For example, if
it can be shown that torsional displacement of the test apparatus adequately correlates with
the intended deformation of the test article, then this may be used to control the applied
displacement during testing.
b) Setup
Refer to the information in the general test method, set up [D.5.2.3.1.5, items b) 1) to 3)] with the
following.
Ensure that the prosthesis is not twisted during mounting.
Adjust the test apparatus to yield the desired torsional displacement (i.e. torsion per test article
gage length).
c) Testing
Refer to the information in the general test method, testing [D.5.2.3.1.5, item c)] with the following:

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1) set the frequency to the established rate and adjust the test system to achieve the intended
minimum and maximum torsional displacement. Verify that the test article deformations are
as intended. After the torsional displacement targets are achieved, begin counting the cycles;
2) verify minimum and maximum torsional displacement at regular time intervals to ensure
that the target values are maintained. Adjust the system as necessary to maintain the desired
operational target.
d) Termination
Refer to the information in the general test method, termination [D.5.2.3.1.5, item d)].
e) Post-test inspection
Refer to the information in the general test method, post-test inspection [D.5.2.3.1.5, item e)].

D.5.2.3.6.6 Expression of results

The test frequency shall be expressed in cycles per second (Hz). Diameters shall be expressed in
millimetres (mm). Torsional displacement shall be expressed in degrees per millimetre of length.

D.5.2.3.6.7 Test report

Refer to the information in the general test method, test report (see D.5.2.3.1.7) with the following.
The intended and measured minimum and maximum test article torsional displacement shall be
reported.

D.5.2.4 Fixation and seal

D.5.2.4.1 Leakage at seal zone

D.5.2.4.1.1 Purpose

This test applies to a device design modification that may affect the seal zone(s).
Determine the leakage between the seal zone(s) of the endovascular prosthesis and a mock artery and
compare the results to those for the unmodified device. This requirement can alternatively be met
through evaluation of Type I endoleaks in a clinical study.
The evaluation of seal zone leakage is not necessary for endovascular prostheses intended for clinical
uses for which seal zone leakage is unlikely to occur or would not likely be associated with adverse
clinical sequelae (e.g. treatment of occlusive lesions).

D.5.2.4.1.2 Materials

The following materials apply:

— modified and unmodified endovascular prostheses;
— accessory devices necessary to accomplish deployment in accordance with the instructions for
use (IFU);
— test fixture(s) incorporating a mock artery to simulate the proximal and distal landing zones
— pressurized fluid fixture capable of delivering water or appropriate fluid, at physiological
temperature (37 ± 2) °C and appropriate pressure;
— a means of lowering the prosthesis graft material permeability to water or other test fluid so as to
allow the necessary pressure differential across the graft material, if appropriate;

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— a means for accurately measuring or determining the total leakage at the proximal and distal
prosthesis seal zones;
— timer.

D.5.2.4.1.3 Sampling

Sampling shall be in accordance with D.2.

D.5.2.4.1.4 Conditioning

Conditioning shall be in accordance with D.3.

D.5.2.4.1.5 Test method

Develop a test method based on the following steps:

a) Insert the test article into the test fixture.
b) Connect the test fixture to the fluid system and allow the test system to stabilize at physiological
temperature, flow and pressure.
c) Measure and record the amount of test fluid leaking between the mock artery and the test article
(i.e. not through the test article wall) and the elapsed time over which leakage occurred.

D.5.2.4.1.6 Expression of results

The seal zone leakage shall be expressed in millilitres per minute (ml/min).

D.5.2.4.1.7 Test report

The test report shall be in accordance with D.4 and include the maximum, minimum, mean and
standard deviation of the seal zone leakage rate and abnormal observations for the modified and
unmodified devices. The test fluid viscosity and density, pressure and flow rate and the model material
of construction shall be reported and justified.

D.5.2.4.2 Migration resistance

D.5.2.4.2.1 Purpose

The purpose of this test is to evaluate the ability of the endovascular prosthesis to resist migration
when subjected to force or pressure.

D.5.2.4.2.2 Materials

The following materials apply:

— endovascular system;
NOTE This test is not designed to evaluate the entire system; however, the system is required to deploy
the prosthesis that is under test.

— accessory devices necessary to accomplish deployment in accordance with the instructions for
use (IFU);
— biological or synthetic mock artery with appropriate diameter, simulated seal zone length and
mechanical properties for the endovascular prosthesis design (e.g. to accommodate hooks/barbs);
— test fixture capable of securely holding the mock artery and the endovascular prosthesis;

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— temperature controlled environment (37 ± 2) °C for prostheses with material properties that are
sensitive to changes between ambient and physiological temperatures.
For a pressure test methodology:
— pressurized fluid fixture capable of delivering water or appropriate fluid at physiological
temperature (37 ± 2) °C;
— pressure measurement system equipped with a suitable pressure gage or mechanical testing system
equipped with a suitable load cell or a force gage;
For a force test methodology:
— mechanical testing system equipped with a suitable load cell or a force gage.

D.5.2.4.2.3 Sampling

Sampling shall be in accordance with D.2.

D.5.2.4.2.4 Conditioning

Conditioning shall be in accordance with D.3 and shall include loading and preconditioning.

D.5.2.4.2.5 Test method

a) For a pressure test methodology:

1) define migration as an allowable amount of translation of the endovascular prosthesis at the
conclusion of the test;
2) deploy the endovascular prosthesis into the mock artery, in accordance with the IFU, such
that the length of the prosthesis within the mock artery is approximately the minimum
recommended in the IFU (e.g. anchoring zone, neck length);
3) initiate pressurization of the system with appropriate conditions (e.g. ramp rate or cyclic
pressure);
Use of this method may require flow to achieve an appropriate pressure gradient between the
inside of the prosthesis and the outside of the prosthesis.
4) record the maximum pressure required to cause device migration or report if the device
migrated at the specific pressure condition. Additionally, if migration was observed, the
amount of migration should be reported.
b) For a force test methodology:
Using a uniform rate of separation (typically 50 mm/min to 200 mm/min), pull out the endovascular
prosthesis from the mock artery and record the peak force.
The migration resistance may be affected by angulation and vessel disease (e.g. calcification). Additional
testing or analyses should be considered to evaluate the effect of angulation and vessel disease on this
parameter. Literature and patient data are appropriate sources to identify challenging anatomy.

D.5.2.4.2.6 Expression of results

The migration resistance force shall be expressed in Newtons (N).

Pressures shall be reported in millimetres of mercury (mmHg).
The length of the prosthesis within the mock artery and the amount of migration shall be expressed in
millimetres (mm).

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D.5.2.4.2.7 Test report

The test report shall be in accordance with D.4 and shall report the presence of migration. If applicable,
include the maximum, minimum, mean and standard deviation of the force or pressure required to
produce migration. The length of the prosthesis within the mock artery and the amount of migration
shall be reported. Rationale shall be provided for the selection of the mock artery (e.g. coefficient of
friction, compliance). The mock artery inner diameter shall be reported and justified. The test fluid
shall be identified.

D.5.2.4.3 Separation force for overlapping endovascular prostheses

D.5.2.4.3.1 Purpose

The purpose of the test is to determine the force required to separate overlapping endovascular
prostheses or modular components (e.g. main body, cuffs, extenders) in the deployed state.

D.5.2.4.3.2 Materials

The following materials apply:

— endovascular system;
NOTE This test is not designed to evaluate the entire system; however, the system is required to deploy
the prosthesis that is under test.

— accessory devices necessary to accomplish deployment in accordance with the instructions for
use (IFU);
— temperature controlled environment (37 ± 2) °C for prostheses with material properties that are
sensitive to changes between ambient and physiological temperatures. Testing should be conducted
in a fluid environment if this environment may affect the force required to separate modular
components.
— mechanical testing system equipped with a suitable load cell, a constant rate of traverse and suitable
gripping fixtures.

D.5.2.4.3.3 Sampling

Sampling shall be in accordance with D.2.

D.5.2.4.3.4 Conditioning

Conditioning shall be in accordance with D.3.

D.5.2.4.3.5 Test Method

Develop a test method based on the following steps:

a) Deploy the modular components of the prosthesis, or the overlapping prostheses, in accordance
with the IFU. The length of the overlap between the modular components or prostheses should
approximate the minimum recommended in the IFU.
The use of an external constraint (e.g. mock artery) at the overlap region should be considered if the
overlap region will not land within an aneurysm.
b) Secure the test article in the test fixtures.
c) Using a uniform rate of separation, pull apart the overlapping components and record the peak force.

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The force to separate the modular components or prostheses may be affected by the angulation
between the components. Additional testing or analyses should be considered to evaluate the effect of
angulation on this parameter.

D.5.2.4.3.6 Expression of results

Force shall be expressed in Newtons (N). The rate of separation shall be expressed in millimetres per
minute (mm/min). The length of the overlap shall be expressed in millimetres (mm).

D.5.2.4.3.7 Test report

The test report shall be in accordance with D.4 and include the maximum, minimum, mean and standard
deviation of the force to separate the modular components or prostheses. The length of the overlap
shall be reported. Justification shall be provided for any overlap region not tested.

D.5.2.5 Patency-related tests

D.5.2.5.1 Compression resistance to perpendicularly applied load (self-expanding, non-aortic

endovascular prostheses)

D.5.2.5.1.1 Purpose

The purpose of this test is to determine the force at which a pre-specified displacement occurs under
a load applied perpendicular to the longitudinal axis of the prosthesis (e.g. compression by two flat
plates, cylindrical bar), for self-expanding, non-aortic prostheses.

D.5.2.5.1.2 Materials

The following materials apply:

— endovascular system;
— mechanical testing system equipped with a suitable load cell and a constant rate of traverse and
appropriate compression fixtures (e.g. flat plates, cylindrical bar);
— temperature controlled environment (37 ± 2) °C for prostheses with material properties that are
sensitive to changes between ambient and physiological temperatures.

D.5.2.5.1.3 Sampling

Sampling shall be in accordance with D.2.

D.5.2.5.1.4 Conditioning

Conditioning shall be in accordance with D.3 and shall include loading, preconditioning and deployment.

D.5.2.5.1.5 Test method

Develop a test method based on the following steps:

a) Deploy the test article to a free state (i.e. unconstrained).
b) Place the deployed test article within the testing apparatus and compress the test article using a
uniform rate of compression. Record the force and the associated displacement while compressing
the test article until a pre-specified displacement is observed.
c) Determine the force required to reach the pre-specified displacement of the test article.

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D.5.2.5.1.6 Expression of results

Force shall be expressed in Newtons (N). Load (force) per unit axial length shall be expressed in
Newtons per millimetre (N/mm). Displacement shall be expressed in millimetres (mm). Diameters shall
be expressed in millimetres (mm).

D.5.2.5.1.7 Test report

The test report shall be in accordance with D.4. Report the maximum, minimum, mean and standard
deviation of the force or force per axial length associated with the pre-specified displacement.

D.5.2.5.2 Crush resistance with perpendicularly applied load (balloon-expandable non-aortic

endovascular prostheses)

D.5.2.5.2.1 Purpose

The purpose of this test is to determine the minimum force at which a pre-specified amount of
permanent deformation occurs under a load applied perpendicular to the longitudinal axis of the
prosthesis (e.g. compression by two flat plates, cylindrical bar), for balloon-expandable, non-aortic
endovascular prostheses.

D.5.2.5.2.2 Materials

The following materials apply:

— endovascular prosthesis;
— mechanical testing system equipped with a suitable load cell and a constant rate of traverse and
appropriate crush fixtures (e.g. flat plates, cylindrical bar);
— temperature controlled environment (37 ± 2) °C for prostheses with material properties that are
sensitive to changes between ambient and physiological temperatures.

D.5.2.5.2.3 Sampling

Sampling shall be in accordance with D.2.

D.5.2.5.2.4 Conditioning

Conditioning shall be in accordance with D.3 and shall include loading, preconditioning and deployment.

D.5.2.5.2.5 Test method

Develop a test method based on the following steps:

a) Expand the test article to a diameter appropriate for the intended clinical use in accordance with
the IFU.
b) Place the test article in the test fixture, and crush the test article using a uniform rate of
compression. Record the force and the associated displacement while crushing the test article until
a pre-specified displacement is observed.
c) Record the force while unloading the test article at a uniform rate.
The pre-specified displacement should be selected to allow for the calculation or measurement of a pre-
specified, justified amount of permanent deformation.
d) Determine the force required to reach the pre-specified permanent deformation of the prosthesis.

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D.5.2.5.2.6 Expression of results

Force shall be expressed in Newtons (N). Load (force) per unit axial length shall be expressed in
Newtons per millimetre (N/mm). Displacement shall be expressed in millimetres (mm). Diameters shall
be expressed in millimetres (mm).

D.5.2.5.2.7 Test report

The test report shall be in accordance with D.4 and shall include a description of the method used for
determining the pre-specified displacement and pre-specified permanent deformation. Report the
maximum, minimum, mean and standard deviation of the force or force per axial length associated
with the pre-specified permanent deformation.

D.5.2.5.3 Crush resistance with radially applied load (balloon-expandable endovascular

prostheses)

D.5.2.5.3.1 Purpose

The purpose of this test is to determine the radially applied load at which a pre-specified amount of
permanent deformation occurs for balloon-expandable endovascular prostheses.

D.5.2.5.3.2 Materials

The following materials apply:

— endovascular system;
NOTE This test is not designed to evaluate the entire system; however, the system is required to deploy
the prosthesis that is under test.

— appropriate mechanical testing equipment, such as the following:

— mechanical testing system equipped with a suitable load cell, a constant rate of traverse,
appropriate gripping fixtures and circumferential tension devices (e.g. loop snares);
— mechanical radial force testing system (e.g. iris tester) equipped with a suitable load cell and a
constant rate of traverse;
— temperature controlled environment (37 ± 2) °C for prostheses with material properties that are
sensitive to changes between ambient and physiological temperatures.

D.5.2.5.3.3 Sampling

Sampling shall be in accordance with D.2.

D.5.2.5.3.4 Conditioning

Conditioning shall be in accordance with D.3 and shall include loading, preconditioning and deployment.

D.5.2.5.3.5 Test method

Develop a test method based on the following steps:

a) Expand the test article to a diameter appropriate for the intended clinical use in accordance with
the IFU.
b) Place the test article in the test fixture and radially compress the test article using a uniform rate of
compression. Record the force and the associated diameter while compressing the test article until
a pre-specified diameter is achieved.

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c) Record the force while unloading the test article at a uniform rate.
The pre-specified diameter should be selected to allow for the calculation or measurement of a pre-
specified, justified amount of permanent deformation (e.g. diameter reduction).
d) Determine the force required to reach the pre-specified permanent deformation (e.g. diameter
reduction).

D.5.2.5.3.6 Expression of results

The outward force per unit axial length shall be expressed in Newtons per millimetre (N/mm) or
pressure in kilopascals (kPa) and surface area in millimetres squared (mm2).
Diameters shall be expressed in millimetres (mm).

D.5.2.5.3.7 Test report

The test report shall be in accordance with D.4, shall include the length of the test article under test and
the minimum, maximum, mean and standard deviation of the radial force per unit length or pressure.
If pressure is reported, the surface area used to calculate the pressure shall be reported. If the entire
length of the prosthesis is not tested, justification for the location(s) or portion(s) of the prosthesis
under test shall be provided.

D.5.2.5.4 Radial force (self-expanding endovascular prostheses)

D.5.2.5.4.1 Purpose

The purpose of this test is to determine the outward force as a function of the diameter for self-
expanding endovascular prostheses.

D.5.2.5.4.2 Materials

The following materials apply:

— endovascular system;
NOTE This test is not designed to evaluate the entire system; however, the system is required to deploy
the prosthesis that is under test.

— appropriate mechanical testing equipment, such as the following:

— mechanical testing system equipped with a suitable load cell, a constant rate of traverse,
appropriate gripping fixtures and circumferential tension devices (e.g. loop snares);
— mechanical radial force testing system (e.g. iris tester) equipped with a suitable load cell and a
constant rate of traverse;
— temperature controlled environment (37 ± 2) °C for prostheses with material properties that are
sensitive to changes between ambient and physiological temperatures.

D.5.2.5.4.3 Sampling

Sampling shall be in accordance with D.2.

Segments or portions of the complete prosthesis may be used as the test article if appropriately justified.

D.5.2.5.4.4 Conditioning

Conditioning shall be in accordance with D.3.

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D.5.2.5.4.5 Test method

Develop a test method based on the following steps:

a) Testing should be completed using the appropriate location(s) of the endovascular prosthesis [e.g.
fixation zone(s)].
b) Deployment of prosthesis and initial setup of apparatus:
Deployment method 1 — Deploy prosthesis directly into test apparatus
1) Set the diameter of the test apparatus at the minimum desired measurement diameter. This
diameter should be less than the lowest intended use diameter as specified in the IFU.
2) Deploy the test article within the test fixture.
Deployment method 2 — Deploy prosthesis to free-state
3) Set the diameter of the test apparatus to a diameter larger than the free-state diameter of the
prosthesis.
4) Place the deployed test article within the testing apparatus.
5) Decrease the diameter of the test apparatus to the minimum desired measurement diameter.
This diameter should be less than the lowest intended use diameter as specified in the IFU.
NOTE The deployment from the delivery system directly into the test apparatus is most clinically
similar to the technique utilized by the physician. However, it might be difficult to control the deployed
length and difficult to detect a misdeployment, resulting in decreased precision in the test data.

c) Increase the diameter of test apparatus at a uniform rate to the minimum intended use diameter
and measure the radial load. Determine the maximum outward force (see Figure D.1).
d) Increase the diameter of the test apparatus at a uniform rate to the maximum intended use
diameter and measure the radial load. Determine the minimum outward force (see Figure D.1).
e) If applicable (e.g. when the force on the loading curve is important to adequately characterize the
prosthesis), the testing may continue to unload to a free diameter and subsequently reload in order
to determine the loads associated with compressing the self-expanding prosthesis.

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Key
SD sheathed diameter
D1 minimum desired measurement diameter
D2 direct deployment diameter
D3 minimum intended use diameter
D4 maximum intended use diameter
D5 free-state diameter
RL3 maximum outward load
RL4 minimum outward load

Figure D.1 — Determination of outward force

D.5.2.5.4.6 Expression of results

The outward force per unit axial length shall be expressed in Newtons per millimetre (N/mm) or
pressure in kilopascals (kPa) and surface area in millimetres squared (mm2). Diameters shall be
expressed in millimetres (mm).

D.5.2.5.4.7 Test report

The test report shall be in accordance with D.4, shall include the length of the test article under test
and the minimum, maximum, mean and standard deviation of the outward force per unit length or
pressure. If pressure is reported, the surface area used to calculate the pressure shall be reported.
If the entire length of the prosthesis is not tested, justification for the location(s) or portion(s) of the
prosthesis under test shall be provided.

D.5.2.5.5 Resistance to kinking (flexibility)

D.5.2.5.5.1 Purpose

The purpose of this test is to determine the minimum radius that the endovascular prosthesis can
accommodate without kinking.

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D.5.2.5.5.2 Materials

The following materials apply:

— endovascular prosthesis;
— materials listed in ISO 7198:2016, A.5.8, as appropriate.

D.5.2.5.5.3 Sampling

Sampling shall be in accordance with D.2.

D.5.2.5.5.4 Conditioning

Conditioning shall be in accordance with D.3 and shall include loading, preconditioning and deployment.

D.5.2.5.5.5 Test method

Testing shall be performed in accordance with the method outlined in ISO 7198:2016, A.5.8.
Device segments can exhibit different kink resistance along the length. As such, multiple measurements
may be necessary to fully characterize the flexibility/kink properties of the device.

D.5.2.5.5.6 Expression of results

The kink radius shall be expressed in millimetres (mm).

D.5.2.5.5.7 Test report

The test report shall be in accordance with D.4 and shall include the maximum, minimum, mean and
standard deviation of the kink radius for the test samples.

D.5.2.6 Permeability

D.5.2.6.1 Integral water leakage

D.5.2.6.1.1 Purpose

The purpose of this test is to evaluate the water leakage between modular components and through
holes in the graft material resulting from the construction of the endovascular prosthesis (e.g. holes
created by suturing stent structures to the graft material).

D.5.2.6.1.2 Materials

The following materials apply:

— endovascular prosthesis;
— materials listed in ISO 7198:2016, A.5.1.3, as appropriate;
— means of lowering the prosthesis graft material permeability to water so as to allow the necessary
pressure differential across the graft material for the evaluation of water leakage between modular
components, if appropriate.

D.5.2.6.1.3 Sampling

Sampling shall be in accordance with D.2.

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D.5.2.6.1.4 Conditioning

Conditioning shall be in accordance with D.3.

D.5.2.6.1.5 Test method

Testing shall be performed on the prosthesis in the deployed state, incorporating all modular
components, and extension devices in accordance with the method outlined in ISO 7198:2016, A.5.1.3.

D.5.2.6.1.6 Expression of results

The surface area of the prosthesis or area under test shall be calculated, and the integral water
permeability shall be expressed in millilitres per centimeter squared per minute (ml/cm2/min).

D.5.2.6.1.7 Test report

The test report shall be in accordance with D.4 and shall include the maximum, minimum, mean and
standard deviation of the integral water permeability/leakage of the test samples. Areas of significant
leakage shall be identified and reported.

D.5.2.6.2 Porosity (non-textile materials)

D.5.2.6.2.1 Purpose

The purpose of this test is to determine the porosity of an endovascular prosthesis constructed of non-
textile materials.

D.5.2.6.2.2 Materials

The following materials apply:

— endovascular prosthesis;
— materials listed in ISO 7198:2016, A.5.1.1, as appropriate.

D.5.2.6.2.3 Sampling

Sampling shall be in accordance with D.2.

D.5.2.6.2.4 Conditioning

Conditioning shall be in accordance with D.3.

D.5.2.6.2.5 Test method

Testing shall be performed in accordance with the method outlined in ISO 7198:2016, A.5.1.1.

D.5.2.6.2.6 Expression of results

The porosity shall be expressed as a percentage.

D.5.2.6.2.7 Test report

The test report shall be in accordance with D.4 and shall include the maximum, minimum, mean and
standard deviation of the porosity.

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D.5.2.6.3 Water entry pressure (non-textile materials)

D.5.2.6.3.1 Purpose

The purpose of this test is to determine the pressure required to force water through a non-textile graft
material of an endovascular prosthesis.

D.5.2.6.3.2 Materials

The following materials apply:

— endovascular prosthesis;
— materials listed in ISO 7198:2016, A.5.1.4, as appropriate.

D.5.2.6.3.3 Sampling

Sampling shall be in accordance with D.2.

D.5.2.6.3.4 Conditioning

Conditioning shall be in accordance with D.3.

D.5.2.6.3.5 Test method

Testing shall be performed in accordance with the method outlined in ISO 7198:2016, A.5.1.4.

D.5.2.6.3.6 Expression of results

The water entry pressure shall be expressed in kilopascals (kPa).

D.5.2.6.3.7 Test report

The test report shall be in accordance with D.4 and shall include the maximum, minimum, mean and
standard deviation of the water entry pressures.

D.5.2.6.4 Water permeability (textile materials)

D.5.2.6.4.1 Purpose

The purpose of this test is to determine the water flow rate through the graft material of an endovascular
prostheses constructed with a water-permeable graft material (e.g. woven graft material).

D.5.2.6.4.2 Materials

The following materials apply:

— endovascular prosthesis;
— materials listed in ISO 7198:2016, A.5.1.2, as appropriate.

D.5.2.6.4.3 Sampling

Sampling shall be in accordance with D.2.

D.5.2.6.4.4 Conditioning

Conditioning shall be in accordance with D.3.

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D.5.2.6.4.5 Test method

Testing shall be performed in accordance with the method outlined in ISO 7198:2016, A.5.1.2.

D.5.2.6.4.6 Expression of results

The surface area of the prosthesis or area under test shall be calculated, and the water permeability
shall be expressed in millilitres per square centimeter per minute (ml/(cm2/min).

D.5.2.6.4.7 Test report

The test report shall be in accordance with D.4 and shall include the maximum, minimum, mean and
standard deviation of the water permeability measurements for the test samples.

D.5.2.7 Sizing-related testing

D.5.2.7.1 Dimensional verification of implant

D.5.2.7.1.1 Purpose

The purpose of this test is, for verification to design specifications, to determine the prosthesis graft
material wall thickness(es) and the endovascular prosthesis dimensions in the deployed state, including
the length(s), outer diameter(s) and all other appropriate dimensions.

D.5.2.7.1.2 Materials

The following materials apply:

— endovascular prosthesis;
— measuring equipment for diameters (e.g. micrometer, optical profile projector, laser-micrometer,
calibrated calipers);
— measuring equipment for wall thickness(es) (e.g. microscope with a calibrated measurement
system, constant load thickness gauge);
— measuring equipment for lengths;
— temperature controlled environment (37 ± 2) °C for prostheses with dimensions that are sensitive
to changes between ambient and physiological temperatures.

D.5.2.7.1.3 Sampling

Sampling shall be in accordance with D.2. For wall thickness measurements, it may be appropriate to
measure the graft material before it is attached to the prosthesis.

D.5.2.7.1.4 Conditioning

Conditioning shall be in accordance with D.3 and shall include loading, preconditioning and deployment.

D.5.2.7.1.5 Test method

a) Outer diameter(s) shall be measured at appropriate locations after deployment in accordance with
the instructions for use (IFU). Endovascular prosthesis incorporating a tapered design should
include outer diameter measurements at the proximal and distal ends of the tapered region.

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For non-circular cross-sections, it may be appropriate to measure and report the maximum and
minimum values.
b) For length(s) and wall thickness(es), the test method shall be performed in accordance with
ISO 7198:2016, A.5.3 and A.5.6.

D.5.2.7.1.6 Expression of results

Diameters and wall thickness(es) shall be expressed in millimetres (mm). Length(s) shall be expressed
in millimetres (mm) or centimeters (cm).

D.5.2.7.1.7 Test report

The test report shall be in accordance with D.4 and shall include the maximum, minimum, mean and
standard deviation of all measured and calculated dimensions.
NOTE Additional guidance can be found in ASTM F2081–01.

D.5.2.7.2 Implant diameter to balloon inflation pressure (balloon-expandable endovascular

prostheses)

D.5.2.7.2.1 Purpose

The purpose of this test is to determine the relationship between the prosthesis diameter and the
balloon inflation pressure for balloon-expandable prostheses.

D.5.2.7.2.2 Materials

The following materials apply:

— endovascular prosthesis;
— balloon for expansion of the prosthesis;
— inflation device, syringe or equivalent, fitted with a means of measuring pressure and capable of
maintaining the inflation pressure;
— fluid for inflation (e.g. room temperature water);
— measuring equipment for diameters (e.g. micrometer, optical profile projector, laser-micrometer);
— temperature controlled environment (37 ± 2) °C, as appropriate.

D.5.2.7.2.3 Sampling

Sampling shall be in accordance with D.2.

D.5.2.7.2.4 Conditioning

Conditioning shall be in accordance with D.3 and shall include loading.

D.5.2.7.2.5 Test method

Develop a test method based on the following steps:

a) Follow the instructions for use (IFU) to prepare the prosthesis for balloon inflation.
b) Inflate the balloon incrementally, allowing the system to stabilize between intervals. Pressures
should be chosen to determine the prosthesis diameter at appropriate intervals (e.g. 1 atm or 1 bar)
over the indicated range of diameters.

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c) Measure the outer diameter of the prosthesis at appropriate locations along the length (e.g. both
ends and the middle of the prosthesis). Outer diameter(s) shall be measured at two perpendicular
directions after deployment. These measurements should be taken immediately after stabilization.
d) Inflation should be terminated when the prosthesis diameter reaches the labelled maximum outer
diameter.
The entire test should be completed rapidly to minimize the effects of viscoelastic behaviour and to
better simulate the inflation method used clinically.

D.5.2.7.2.6 Expression of results

The prosthesis diameters should be expressed in units of millimetres (mm) and the associated
pressures in kilopascals (kPa) and/or atmospheres of pressure (atm).

D.5.2.7.2.7 Test report

The test report shall be in accordance with D.4 and shall include the maximum, minimum, mean and
standard deviation of the endovascular prosthesis diameter measurements and associated pressures.
These data may be reported in tabular or graphical format.

D.5.2.7.3 Implant length to diameter relationship (endovascular prostheses that have clinically
relevant length changes with diameter changes)

D.5.2.7.3.1 Purpose

The purpose of this test is to determine the relationship between the length and diameter for
endovascular prostheses that have clinically relevant length changes with diameter changes.

D.5.2.7.3.2 Materials

The following materials apply:

— endovascular system;
NOTE 1 This test is not designed to evaluate the entire system; however, the system is required to deploy the
prosthesis that is under test.

— measuring equipment for length;

— tube with inner diameters corresponding to the minimum and maximum vessel diameters indicated
in the instructions for use (IFU) for each prosthesis size under test for self-expanding prostheses;
NOTE 2 For balloon-expandable prostheses, use of a tube in testing is optional.

— accessory devices necessary to accomplish deployment in accordance with the IFU;

— temperature controlled environment (37 ± 2) °C for prostheses with dimensions that are sensitive
to changes between ambient and physiological temperatures.

D.5.2.7.3.3 Sampling

Sampling shall be in accordance with D.2.

D.5.2.7.3.4 Conditioning

Conditioning shall be in accordance with D.3.

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D.5.2.7.3.5 Test method

For a balloon expandable stent with significant recoil, there can be difficulty in obtaining appropriate
apposition of the prosthesis to the wall of the tube. Alternative methodology, that is, without the use of
a tube, may need to be developed to appropriately evaluate this attribute for such devices.
a) Measure the length of the unexpanded stent.
b) Deploy the prosthesis in accordance with the IFU into the tube that represents the minimum target
diameter following the instructions for use (IFU).
c) Measure the prosthesis length within the tube.
d) Repeat steps b) and c) at the maximum target diameter.
Measurements at multiple diameters may be made using the same device, if appropriate and justified.
The implant length to diameter relationship may be affected by angulation. Additional testing or
analyses should be considered to evaluate the effect of angulation on this parameter, as appropriate.

D.5.2.7.3.6 Expression of results

Prosthesis length shall be reported in centimeters (cm) or millimetres (mm) and associated diameter in
millimetres (mm).

D.5.2.7.3.7 Test report

The test report shall be in accordance with D.4 and include the maximum, minimum, mean and the
standard deviation of the device length at each corresponding diameter. These data should be reported
in a tabular format.

D.5.2.7.4 Recoil (balloon-expandable endovascular prostheses)

D.5.2.7.4.1 Purpose

The purpose of this test is to determine the amount of elastic recoil (per cent of the diameter reduction)
after the deployment of a balloon-expandable prosthesis.

D.5.2.7.4.2 Materials

The following materials apply:

— endovascular system;
NOTE This test is not designed to evaluate the entire system; however, the system is required to deploy
the prosthesis that is under test.

— accessory devices necessary to allow for appropriate expansion of the prosthesis;

— inflation device, syringe or equivalent, fitted with a means of measuring pressure and capable of
maintaining the inflation pressure;
— fluid for inflation (e.g. room temperature water);
— measuring equipment for diameters (e.g. micrometer, optical profile projector, laser-micrometer);
— temperature controlled environment (37 ± 2) °C for prostheses with material properties that are
sensitive to changes between ambient and physiological temperatures;
— timer with an accuracy of ±1 s.

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D.5.2.7.4.3 Sampling

Sampling shall be in accordance with D.2.

D.5.2.7.4.4 Conditioning

Conditioning shall be in accordance with D.3 and shall include loading and preconditioning.

D.5.2.7.4.5 Test method

a) Initiate deployment of the prosthesis to enable device expansion.

b) Inflate the balloon to expand the prosthesis using the recommended inflation pressure and hold
the pressure to allow the balloon and prosthesis to stabilize (approximately 30 s).
c) Measure the outer diameter of the prosthesis at appropriate locations along the length (e.g. both
ends and the middle of the prosthesis). Outer diameter(s) shall be measured at two perpendicular
directions after deployment.
d) Deflate and remove the balloon catheter.
e) Allow the prosthesis to stabilize (approximately 30 s).
f) Repeat step c) at the same locations.
g) Calculate the average percent recoil at each longitudinal location. Calculate the prosthesis recoil:
% Recoil = (outer diameterinflated – outer diameter final)/outer diameterinflated × 100
h) Correlate recoil with recommended sizing.

D.5.2.7.4.6 Expression of results

The prosthesis recoil shall be expressed in per cent (%).

D.5.2.7.4.7 Test report

The test report shall be in accordance with D.4 and shall include the maximum, minimum, mean and
standard deviation of the recoil measurements at each longitudinal location.
NOTE Additional information can be found in ASTM F2079–02.

D.5.2.8 Strength

D.5.2.8.1 Burst strength

D.5.2.8.1.1 Purpose

The purpose of this test is to determine the pressurized burst strength of the graft material. It may also
be appropriate to determine the burst strength of the entire endovascular prosthesis if processing may
reduce the strength of the graft material.

D.5.2.8.1.2 Materials

The following materials apply:

— endovascular prosthesis;
— materials listed in ISO 7198:2016, A.5.2.1, as appropriate.

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D.5.2.8.1.3 Sampling

Sampling shall be in accordance with D.2.

D.5.2.8.1.4 Conditioning

Conditioning shall be in accordance with D.3.

D.5.2.8.1.5 Test method

Testing shall be performed in accordance with the method outlined in ISO 7198:2016, A.5.2.1.

D.5.2.8.1.6 Expression of results

The burst strength of each sample is expressed in kilopascals (kPa).

D.5.2.8.1.7 Test report

The test report shall be in accordance with D.4 and shall include the maximum, minimum, mean and
standard deviation of the burst strength.

D.5.2.8.2 Factory seam strength (endovascular prostheses with seams in the graft material)

D.5.2.8.2.1 Purpose

The purpose of this test is to determine the tensile strength of any factory manufactured seams in the
graft material.

D.5.2.8.2.2 Materials

The following materials apply:

— endovascular prosthesis graft material;
— materials listed in ISO 7198, as appropriate.

D.5.2.8.2.3 Sampling

Sampling shall be in accordance with D.2.

D.5.2.8.2.4 Conditioning

Conditioning shall be in accordance with D.3.

D.5.2.8.2.5 Test method

Testing shall be performed in accordance with the method outlined in ISO 7198:2016, A.5.2.2.

D.5.2.8.2.6 Expression of results

The burst strength of each sample is expressed in kilopascals (kPa).

D.5.2.8.2.7 Test report

The test report shall be in accordance with D.4 and shall include the maximum, minimum, mean and
standard deviation of longitudinal tensile strength.

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D.5.2.8.3 Longitudinal tensile strength

D.5.2.8.3.1 Purpose

The purpose of this test is to determine the longitudinal tensile strength of the graft material.

D.5.2.8.3.2 Materials

The following materials apply:

— endovascular prosthesis or graft material;
— materials listed in ISO 7198:2016, A.5.2.2, as appropriate.

D.5.2.8.3.3 Sampling

Sampling shall be in accordance with D.2.

D.5.2.8.3.4 Conditioning

Conditioning shall be in accordance with D.3.

D.5.2.8.3.5 Test method

Testing shall be performed in accordance with the method outlined in ISO 7198:2016, A.5.2.2. For this
test, the minimum load to cause failure shall be determined rather than the load at yield or break.

D.5.2.8.3.6 Expression of results

The longitudinal tensile strength shall be expressed in Newtons (N).

D.5.2.8.3.7 Test report

The test report shall be in accordance with D.4 and shall include the maximum, minimum, mean and
standard deviation of the longitudinal tensile strength.

D.5.2.8.4 Strength after repeated puncture (endovascular prostheses for vascular access)

D.5.2.8.4.1 Purpose

The purpose of this test is to determine the strength of the endovascular prostheses following
repeated dialysis-needle punctures for a prosthesis that will be cannulated to provide blood access for
haemodialysis.

D.5.2.8.4.2 Materials

The following materials apply:

— endovascular prosthesis;
— materials listed in ISO 7198:2016, A.5.2.6, as appropriate.

D.5.2.8.4.3 Sampling

Sampling shall be in accordance with D.2.

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D.5.2.8.4.4 Conditioning

Conditioning shall be in accordance with D.3.

D.5.2.8.4.5 Test method

Testing shall be performed in accordance with the method outlined in ISO 7198:2016, A.5.2.6.

D.5.2.8.4.6 Expression of results

The strength before and after puncturing shall be expressed in the units specified ISO 7198:2016,
A.5.2.6.

D.5.2.8.4.7 Test report

The test report shall be in accordance with D.4 and shall include the maximum, minimum, mean and
standard deviation of the strength before and after puncturing.

D.5.2.8.5 Strength of the connection(s) between the graft material and a discrete fixation
system(s)

D.5.2.8.5.1 Purpose

The purpose of this test is to determine the strength of the connection(s) between the graft material
and the fixation system(s).

D.5.2.8.5.2 Materials

The following materials apply:

— endovascular prosthesis;
— mechanical testing system equipped with a suitable load cell, a constant rate of traverse and
appropriate gripping fixtures;
— temperature controlled environment (37 ± 2) °C for bonds that are temperature sensitive.

D.5.2.8.5.3 Sampling

Sampling shall be in accordance with D.2.

D.5.2.8.5.4 Conditioning

Conditioning shall be in accordance with D.3.

D.5.2.8.5.5 Test method

a) Secure the sample in the test fixture(s).

b) Apply a load to the bond using a constant crosshead speed (e.g. 200 mm/min). Record the force
required to initiate separation of the components and/or the peak force required to separate the
components.

D.5.2.8.5.6 Expression of results

Force shall be expressed in Newtons (N).

D.5.2.8.5.7 Test reports

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The test report shall be in accordance with D.4 and shall include the mode of failure (e.g. tear in
covering, rupture of suture, separation of bond) and the maximum, minimum, mean and standard
deviation of the force required to initiate separation of the components and/or the peak force required
to completely separate the components.

D.6 Supplement to D.5.2.3.2 radial fatigue and durability — Sample formulae for
calculation of the inner diameter (or radius) from the outer diameter (or radius)
D.6.1 Linear elastic mechanics with zero longitudinal strain (constant length)
Calculations here assume linear elastic mechanics for a thick-walled cylinder assuming a uniform
concentric annular geometry. Formulae (D.5) to (D.8) provide relationships between the inner and
outer tube diameters at various states of expansion (e.g. unpressurized and pressurized, diastolic and
systolic). These formulae can be derived using standard engineering equations, such as those presented
in Advanced Mechanics of Materials, 2nd Ed. Robert D. Cook and Warren C. Young, 1999.
For example, if the initial inner and outer radii of a mock artery are known and it is desired to determine
the inner radius change associated with an outer radius change, Formula (D.8) may be used.
Similarly, if the initial inner and outer radii of a mock artery are known and it is desired to determine
the outer radius associated with an inner radius target, Formula (D.6) may be used.
Formula (D.5) may be used to determine the change in OD when the change in ID is known. Formula (D.7)
may be used to determine the change in ID when the change in OD is known.

2(1 − ν 2 )  Db
DOD = 2 a  (D.5)
 a 2
a 2   b 
1 + − ν (1 − + 2ν )   
 b 2
b 2 
 
 
 
 2(1 − ν ) 2  D b  
OD 2 = 2 a + a  (D.6)
  a2 a2   b 
 1 + − ν (1 − + 2ν )   
  b 2
b 2  
 
 a2 a2 
1 + − ν (1 − + 2ν ) 
 b2 b2   Da 
DID = 2   b  (D.7)
2(1 − ν )2  a 
 
  a2 a2  
 1 + − ν (1 − + 2ν )  
  b 2
b 2   Da  
ID 2 = 2 b +   b
  (D.8)
 2(1 − ν )2
 a 
 
 

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where

ΔOD is the change in outer diameter due to pressurization;

a is the initial outer radius (e.g. the un-pressurized or lower pressure condition);

b is the initial inner radius (e.g. the un-pressurized or lower pressure condition);

ν is the Poisson’s ratio;

Δb is the change in inner radius due to a change in pressure = ΔID/2;

Δa is the change in outer radius due to a change in pressure = ΔOD/2;

ΔID is the change in inner diameter due to pressurization;

ID2 is the pressurized inner diameter;

OD2 is the pressurized outer diameter.

NOTE In the formulae and definitions of variables, Δ is not intended to be an operational symbol.

D.6.2 Linear elastic mechanics with zero longitudinal stress (unconstrained length)
Calculations here assume linear elastic mechanics for a thick-walled cylinder assuming a uniform
concentric annular geometry. Formulae (D.9) to (D.12) provide relationships between the inner and
outer tube diameters at various states of expansion (e.g. unpressurized and pressurized, diastolic and
systolic). These formulae can be derived using standard engineering formulae, such as those presented
in Roark’s Formulas for Stress and Strain, Case 1a (cylinder under uniform internal radial pressure with
a longitudinal pressure of zero or externally balanced), 6th ed. 1989.
For example, if the initial inner and outer radii of a mock artery are known and it is desired to determine
the inner radius change associated with an outer radius change, Formulae (D.12) may be used.
Similarly, if the initial inner and outer radii of a mock artery are known and it is desired to determine
the outer radius associated with an inner radius target, Formulae (D.10) may be used.
Formulae (D.9) may be used to determine the change in OD when the change in ID is known.
Formulae (D.11) may be used to determine the change in ID when the change in OD is known.

 2ab   a 2 + b2 
DOD = 2Db    + ν  (D.9)
 a 2 -b 2   a 2 − b2 
  


 2ab   a2 + b2   
OD = 2 a + Db    + ν   (D.10)
2
  a 2 -b 2    a 2 − b 2  
  

DID = 2Da 
 a 2 + b2 + ν a 2 -b2 
 ( 

) (D.11)
 2ab 
 


ID = 2 b + Da 
 (
 a 2 + b 2 + ν a 2 -b 2  
 ) (D.12)

2
  2ab 
  

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where

ΔOD is the change in outer diameter due to pressurization;

a is the initial outer radius (e.g. the un-pressurized or lower pressure condition);

b is the initial inner radius (e.g. the un-pressurized or lower pressure condition);

ν is the Poisson’s ratio;

Δb is the change in inner radius due to pressurization = ΔID/2;

Δa is the change in outer radius due to pressurization = ΔOD/2;

ΔID is the change in inner diameter due to pressurization;

ID2 is the pressurized inner diameter;

OD2 is the pressurized outer diameter.

NOTE In the formulae and definitions of variables, Δ is not intended to be an operational symbol.

D.6.3 Nonlinear elastic mechanics

Calculations here assume nonlinear elastic mechanics of stress/strain for a thick-walled cylinder
assuming constant volume mechanical properties and a uniform concentric straight annular geometry.
Formulae (D.13) and (D.16) provide the inner diameter at the maximum and minimum states of
expansion (e.g. unpressurized and pressurized, diastolic and systolic). For example, if the initial
inner and outer radii of a mock artery are known and it is desired to determine the inner radius at
the maximum and minimum applied pressure associated with the measured maximum and minimum
outside diameters, Formulae (D.13) and (D.14) may be used. The parameter λ may be calculated by
measuring the undeformed length of the mock artery and the deformed (i.e. stretched) mock artery
in testing equipment using Formulae (D.15). The parameter λ may also be calculated by measuring
the undeformed (i.e. zero internal pressure) outer diameter and diameter while the mock artery is
stretched on the testing equipment and using Formulae (D.16).
References:
Billington and Tate, “Extension, Inflation, and Torsion of an Incompressible Circular Cylindrical
Tube,” Physics of Deformation and Flow, McGraw-Hill, 1981, Chapter 8, Section −1.
Ogden, R. W., Nonlinear Elastic Deformations, Dover, 1997, Sections 5.2.3 and 5.3.3, pp. 111–112.
Humphrey, J. D., Cardiovascular Solid Mechanics, Springer-Verlag, 2001, Sections 4.2.2 and 7.3.1.

( )
1/2
d i,max = d o,max 2 − Do2 − Di2 / λ  (D.13)
 

( )
1/2
d i,min = d o,min 2 − Do2 − Di2 / λ  (D.14)
 

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where

l
λ= (D.15)
L

Do2
λ= (with zero applied pressure) (D.16)
d o2

Di is the change in outer diameter due to pressurization;

Do is the initial outer radius (e.g. the unpressurized or lower pressure condition);

L is the initial inner radius (e.g. the unpressurized or lower pressure condition);

di Poisson’s ratio;

do is the change in inner radius due to pressurization = ΔID/2;

l is the change in outer radius due to pressurization = ΔOD/2;

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Bibliography

[1] ISO 594-1,1) Conical fittings with 6 % (Luer) taper for syringes, needles and certain other
medical equipment — Part 1: General requirements
[2] ISO 594-2,2) Conical fittings with 6 % (Luer) taper for syringes, needles and certain other
medical equipment — Part 2: Lock fittings
[3] ISO 5840-1, Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements
[4] ISO 10555-1, Intravascular catheters — Sterile and single-use catheters — Part 1: General
requirements
[5] ISO 10555-4, Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation
catheters
[6] ISO 11070, Sterile single-use intravascular introducers, dilators and guidewires
[7] ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
[8] ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
[9] ISO 16429, Implants for surgery — Measurements of open-circuit potential to assess corrosion
behaviour of metallic implantable materials and medical devices over extended time periods
[10] ISO 17475, Corrosion of metals and alloys — Electrochemical test methods — Guidelines for
conducting potentiostatic and potentiodynamic polarization measurements
[11] ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the
development, validation and routine control of a sterilization process for medical devices
[12] ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
[13] ISO/TS 17137, Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable
implants
[14] ISO/TR 37137, Cardiovascular biological evaluation of medical devices — Guidance for absorbable
implants
[15] ANSI/AAMI ST67, Sterilization of health care products — Requirements and guidance for selecting
a sterility assurance level (SAL) for products labeled “sterile”
[16] ASTM F640, Standard Test Method for Determining Radiopacity for Medical Use
[17] ASTM F746, Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant
Materials
[18] ASTM F2052, Standard Test Method for Measurement of Magnetically Induced Displacement Force
on Medical Devices in the Magnetic Resonance Environment
[19] ASTM F2119, Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
[20] ASTM F2129, Standard Test Method for Conducting Cyclic Potentiodynamic Polarization
Measurements to Determine the Corrosion Susceptibility of Small Implant Devices

1) Replaced by ISO 80369-7.

2) Replaced by ISO 80369-7.

© ISO 2017 – All rights reserved  121

ISO 25539-1:2017(E)


[21] ASTM F2182, Standard Test Method for Measurement of Radio Frequency Induced Heating On or
Near Passive Implants During Magnetic Resonance Imaging
[22] ASTM F2213, Standard Test Method for Measurement of Magnetically Induced Torque on Medical
Devices in the Magnetic Resonance Environment
[23] ASTM F2394, Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent
Mounted on Delivery System
[24] ASTM F2477, Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents
[25] ASTM F2914, Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
[26] ASTM F2942, Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of
Vascular Stents
[27] ASTM F3044, Test Method for Standard Test Method for Evaluating the Potential for Galvanic
Corrosion for Medical Implants
[28] ASTM F3067, Guide for Radial Loading of Balloon Expandable and Self Expanding Vascular Stents
[29] ASTM F3044, Test Method for Standard Test Method for Evaluating the Potential for Galvanic
Corrosion for Medical Implants
[30] ASTM G5, Standard reference test method for making potentiostatic and Potentiodynamic Anodic
Polarization Measurements
[31] ASTM G61, Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements
for Localized Corrosion Susceptibility of Iron-, Nickel-, or Cobalt-Based Alloys
[32] ASTM G71, Standard Guide for Conducting and Evaluating Galvanic Corrosion Tests in Electrolytes
[33] ASTM G102, Standard Practice for Calculation of Corrosion Rates and Related Information from
Electrochemical Measurements
[34] EN 556, Sterilization of medical devices — Requirements for medical devices to be designated
“STERILE”
[35] Billington E.W., & Tate A. Extension, Inflation, and Torsion of an Incompressible Circular
Cylindrical Tube. In: Physics of Deformation and Flow. McGraw-Hill, 1981
[36] Cook R.D., & Young W.C. Advanced Mechanics of Materials. Second Edition, 1999
[37] Humphrey J.D. Cardiovascular Solid Mechanics, Springer-Verlag, Sections 4.2.2 and 7.3.1, 2001
[38] Ogden R.W. Nonlinear Elastic Deformations, Dover, Sections 5.2.3 and 5.3.3, pp. 111–112, 1997
[39] Young W.C., & Budynas R.G. Roark’s Formulas for Stress and Strain Case 1a, 6th ed., 1989

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ICS 11.040.40
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© ISO 2017 – All rights reserved