single-use catheters — Part 5: Over-needle peripheral catheters Cathéters intravasculaires — Cathéters stériles et non réutilisables — Partie 5: Cathéters périphériques iTeh STANDARD PREVIEW à aiguille interne
(standards.iteh.ai) ISO 10555-5:2013 https://standards.iteh.ai/catalog/standards/sist/72808902-98f2-4fe7-b5f0- b62a4af6cfd3/iso-10555-5-2013
Foreword......................................................................................................................................................................................................................................... iv 1 Scope.................................................................................................................................................................................................................................. 1 2 Normative references....................................................................................................................................................................................... 1 3 Terms and definitions...................................................................................................................................................................................... 1 4 Requirements........................................................................................................................................................................................................... 2 4.1 General............................................................................................................................................................................................................ 2 4.2 Multilumen catheters......................................................................................................................................................................... 2 4.3 Physical requirements....................................................................................................................................................................... 3 4.4 Information to be supplied by the manufacturer....................................................................................................... 4 Annex A (normative) Determination of strength of union of needle hub and needle tube.......................... 5 Annex B (informative) Colours for opaque catheter hubs.............................................................................................................. 6 Annex C (informative) Needle point geometries....................................................................................................................................... 7 Annex D (normative) Determination of liquid leakage from vent fitting....................................................................... 8 Bibliography.............................................................................................................................................................................................................................. 10
iTeh STANDARD PREVIEW
(standards.iteh.ai) ISO 10555-5:2013 https://standards.iteh.ai/catalog/standards/sist/72808902-98f2-4fe7-b5f0- b62a4af6cfd3/iso-10555-5-2013
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. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. 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. ISO 10555-5 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal products and intravascular catheters. This second edition cancels and replaces the first edition (ISO 10555-5:1996), which has been technically revised. It also incorporates the Amendment ISO 10555-5:1996/Amd 1:1999 and the Technical iTeh STANDARD PREVIEW Corrigendum ISO 10555-5:1996/Cor 1:2002. (standards.iteh.ai) ISO 10555 consists of the following parts, under the general title Intravascular catheters — Sterile and single-use catheters: ISO 10555-5:2013 — Part 1: General requirements https://standards.iteh.ai/catalog/standards/sist/72808902-98f2-4fe7-b5f0- b62a4af6cfd3/iso-10555-5-2013 — Part 3: Central venous catheters — Part 4: Balloon dilatation catheters — Part 5: Over-needle peripheral catheters The following part is under preparation: — Part 6: Subcutaneous implanted ports The following part has been withdrawn and the content has been included in ISO 10555-1: — Part 2: Angiographic catheters Attention is drawn to ISO 11070, which specifies requirements for accessory devices for use with intravascular catheters, and to ISO 14972, which specifies requirements for sterile obturators for use with over-needle peripheral catheters.
Intravascular catheters — Sterile and single-use catheters —
Part 5: Over-needle peripheral catheters
1 Scope This part of ISO 10555 specifies requirements for over-needle peripheral intravascular catheters, intended for accessing the peripheral vascular system, supplied in the sterile condition and intended for single use.
2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements1) iTeh STANDARD PREVIEW ISO 9626, Stainless steel needle tubing for the manufacture of medical devices (standards.iteh.ai) ISO 10555-1, Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
ISO 10555-5:2013 3 Terms and definitions https://standards.iteh.ai/catalog/standards/sist/72808902-98f2-4fe7-b5f0- b62a4af6cfd3/iso-10555-5-2013 For the purposes of this document, the terms and definitions given in ISO 10555-1 and the following apply. 3.1 over-needle peripheral intravascular catheter catheter designed for the introduction or withdrawal of liquids or devices into or from the peripheral vascular system 3.2 needle assembly comprising at least a needle tube attached to, and communicating with, a needle hub
See Figure 1. 3.3 needle tube rigid tube with one end sharpened to facilitate entry into body tissue 3.4 needle hub fitting attached to the needle tube, providing communication with its bore 3.5 vent fitting fixed or removable fitting permitting venting of air while restricting or preferably preventing the escape of blood
1) Upon its publication, ISO 80369-7 will replace ISO 594-1 and ISO 594-2.
3.6 catheter unit assembly comprising the catheter tube, catheter hub and any integral fittings
See Figure 1. 3.7 flashback blood flow into the needle hub
Key a 0 < a < 1 mm (see 4.3.2) l1 effective length 1 catheter tube iTeh STANDARD PREVIEW 2 catheter hub (standards.iteh.ai) 3 needle tube 4 needle hub ISO 10555-5:2013 https://standards.iteh.ai/catalog/standards/sist/72808902-98f2-4fe7-b5f0- 5 vent fitting b62a4af6cfd3/iso-10555-5-2013 6 heel of bevel 7 catheter unit
NOTE Other design features may include wings, injection ports integral with the catheter hub, other means of connecting to the fluid path, protection against accidental needle stick injury, etc. The catheter tube may have a single lumen or multiple lumens.
The catheter unit shall be colour coded in accordance with Table 1 to indicate the nominal outside diameter of the catheter tube.
4.3.2 Catheter unit
The distal end shall be tapered for ease of insertion and shall fit closely to the needle. When the needle is fully inserted into the catheter unit, the catheter tube shall neither extend beyond the heel of the needle bevel nor be more than 1 mm from it (see dimension a in Figure 1).
4.3.3 Needle
4.3.3.1 Material
If a steel tube is used, it shall comply with ISO 9626.
Table 1 — Colour coding and corresponding sizes of catheter
Nominal outside diameter of Range of actual outside Coloura,b Gaugec catheter tube diameter mm iTeh STANDARD mm PREVIEW 0,6 0,550 to 0,649 Violet 26 0,7 (standards.iteh.ai) 0,650 to 0,749 Yellow 24 0,8; 0,9 0,750 ISO to 0,949 10555-5:2013 Deep blue 22 1,0; 1,1 https://standards.iteh.ai/catalog/standards/sist/72808902-98f2-4fe7-b5f0- 0,950 to 1,149 Pink 20 1,2; 1,3 b62a4af6cfd3/iso-10555-5-2013 1,150 to 1,349 Deep green 18 1,4; 1,5 1,350 to 1,549 White 17 1,6; 1,7; 1,8 1,550 to 1,849 Medium grey 16 1,9; 2,0; 2,1; 2,2 1,850 to 2,249 Orange 14 2,3; 2,4; 2,5 2,250 to 2,549 Red 13 2,6; 2,7; 2,8 2,550 to 2,849 Pale blue 12 3,3; 3,4 3,250 to 3,549 Light brown 10 a The colour may be opaque or translucent. Suggested colour references for opaque materials are given in Annex B. b The colour coding is usually applied to the catheter hub or to an integral fitting. c The use of gauge number is optional.
4.3.3.2 Needle point
When examined by normal or corrected-to-normal vision with × 2,5 magnification, the needle point shall appear sharp and free from feather edges, burrs and hooks. NOTE The point should be designed to be non-coring. Annex C shows examples of typical needle point geometries.
4.3.3.3 Needle hub
The needle hub or another feature shall permit detection of flashback and shall be designed to communicate with the bore of the introducer needle tube. If the introducer needle is provided with a removable vent fitting, the needle hub shall terminate in a female fitting with a 6 % (Luer) taper complying with ISO 594-1.
4.3.3.4 Strength of union between needle hub and needle tube
When tested in accordance with Annex A, the needle tube shall not be loosened in the needle hub.
4.3.4 Vent fitting
A vent fitting shall be provided. When tested in accordance with Annex D, fluid shall not leak out of the vent fitting within 15 s.
4.4 Information to be supplied by the manufacturer
Information supplied by the manufacturer shall comply with ISO 10555-1 and shall also include the following: a) the flowrate for each lumen; b) a warning against attempting to re-insert a partially or completely withdrawn needle; c) on each primary package, the colour code, unless the colour on the product is visible through the unit package, and the outside diameter, as defined in Table 1. NOTE Units of measurement systems other than those specified in this part of ISO 10555 can additionally be given.
iTeh STANDARD PREVIEW
(standards.iteh.ai) ISO 10555-5:2013 https://standards.iteh.ai/catalog/standards/sist/72808902-98f2-4fe7-b5f0- b62a4af6cfd3/iso-10555-5-2013
Determination of strength of union of needle hub and needle tube
A.1 Principle A force is applied (successively tensile and compressive) to the needle tube and needle hub and the tube- hub union is then examined for loosening.
A.2 Apparatus Tensile testing apparatus, capable of exerting forces of up to 20 N with an accuracy of ± 1 %.
A.3 Test procedure
A.3.1 Condition the needle in an atmosphere of 40 % to 60 % relative humidity and a temperature of
(22 ± 2) °C for 2 h immediately before the test. iTeh STANDARD PREVIEW A.3.2 Clamp the needle tube and the needle hub in the jaws of the tensile testing apparatus and apply (standards.iteh.ai) successively, once each, at a rate of 100 mm/min, a tensile and a compressive force of
— 10 N when testing needles of nominal ISO 10555-5:2013
outside diameter less than 0,6 mm; https://standards.iteh.ai/catalog/standards/sist/72808902-98f2-4fe7-b5f0- — 20 N when testing needles of nominal outside diameter 0,6 mm or greater. b62a4af6cfd3/iso-10555-5-2013
A.3.3 Examine the union of needle tube and needle hub and record whether the needle tube has been loosened.
A.4 Test report
The test report shall include the following information: a) identity of the needle; b) outside diameter of the needle, expressed in millimetres; c) load applied (i.e. 10 N or 20 N); d) whether or not the needle tube was loosened in the hub.
From A Biomedical Scientist to A Clinical Scientist The UK Science Training Programme via Equivalence (STPE) Step-by-Step Process: Continuing Professional Development in Pathology For Medical Laboratory Professionals
From A Biomedical Scientist to A Clinical Scientist The UK Science Training Programme via Equivalence (STPE) Step-by-Step Process: Continuing Professional Development in Pathology For Medical Laboratory Professionals
