IEC 60601-2-18

®
Edition 3.0 2009-08

INTERNATIONAL
STANDARD
NORME
INTERNATIONALE colour
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Medical electrical equipment –

iTeh STANDARD PREVIEW
Part 2-18: Particular requirements for the basic safety and essential performance
of endoscopic equipment (standards.iteh.ai)
IEC 60601-2-18:2009
Appareils électromédicaux –
https://standards.iteh.ai/catalog/standards/sist/e74a8019-9355-4b10-80f4-
Partie 2-18: Exigences particulières pour la sécurité de base et les performances
5c6d90afefd4/iec-60601-2-18-2009
essentielles des appareils d'endoscopie
IEC 60601-2-18:2009
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 IEC 60601-2-18
®
Edition 3.0 2009-08

INTERNATIONAL
STANDARD
NORME
INTERNATIONALE colour
inside

Medical electrical equipment – iTeh STANDARD PREVIEW

Part 2-18: Particular requirements for the basic safety and essential
performance of endoscopic equipment
(standards.iteh.ai)
IEC 60601-2-18:2009
Appareils électromédicaux –
https://standards.iteh.ai/catalog/standards/sist/e74a8019-9355-4b10-80f4-
Partie 2-18: Exigences particulières pour la sécurité de base et les
5c6d90afefd4/iec-60601-2-18-2009
performances essentielles des appareils d'endoscopie

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION

COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE PRICE CODE
CODE PRIX X
ICS 11.040.50 ISBN 978-2-88910-216-7

® Registered trademark of the International Electrotechnical Commission

Marque déposée de la Commission Electrotechnique Internationale
 –2– 60601-2-18 © IEC:2009

CONTENTS
FOREWORD...........................................................................................................................4
INTRODUCTION.....................................................................................................................6

201.1 Scope, object and related standards .........................................................................8

201.2 Normative references ................................................................................................9
201.3 Terms and definitions .............................................................................................. 10
201.4 General requirements.............................................................................................. 12
201.5 General requirements for testing of ME EQUIPMENT ................................................... 14
201.6 Classification of ME EQUIPMENT and ME SYSTEMS ...................................................... 14
201.7 M E EQUIPMENT identification, marking and documents .............................................. 14
201.8 Protection against electrical HAZARDS from ME EQUIPMENT ........................................ 18
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS .............. 19
201.10 Protection against unwanted and excessive radiation HAZARDS ................................ 20
201.11 Protection against excessive temperatures and other HAZARDS ................................ 21
201.12 Accuracy of controls and instruments and protection against hazardous
outputs .................................................................................................................... 24
201.13 H AZARDOUS SITUATIONS and fault conditions ............................................................. 25
201.14
iTeh STANDARD PREVIEW
P ROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS ( PEMS ) ............................................... 25
201.15 Construction of (standards.iteh.ai)
................................................................................. 25
ME EQUIPMENT

201.16 M E SYSTEMS ............................................................................................................ 26

IEC 60601-2-18:2009
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS ............................. 26
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202 Electromagnetic compatibility – Requirements and tests ......................................... 26
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Annexes ............................................................................................................................... 27
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS .................................................................................................................... 27
Annex D (informative) Symbols on marking .......................................................................... 29
Annex J (informative) Survey of insulation paths .................................................................. 31
Annex AA (informative) Particular guidance and rationale .................................................... 33
Annex BB (informative) Clauses of this standard addressing essential principles of
safety and performance of medical devices (GHTF/SG1/N41R9:2005) .................................. 43

Index of defined terms used in this particular standard.......................................................... 45

Figure 201.101 – Identification of LIGHT EMISSION PART .......................................................... 12

Figure 201.102 – Measurement of CAPACITIVELY - COUPLED HF CURRENT from conductive
parts of an ENDOSCOPE .......................................................................................................... 24
Figure 201.J.101 – Insulation example 101 ........................................................................... 31
Figure 201.J.102 – Insulation example 102 ........................................................................... 32
Figure 201.J.103 – Insulation example 103 ........................................................................... 32
Figure AA.101 – Illustration of typical CONFIGURATION FOR ENDOSCOPIC APPLICATION .............. 34

Table 201.101 – List of ESSENTIAL PERFORMANCE requirements ............................................. 13

60601-2-18 © IEC:2009 –3–

Table 201.C.101 – Marking on the outside of ENDOSCOPIC EQUIPMENT or its parts .................. 27
Table 201.C.102 – Marking on the inside of ENDOSCOPIC EQUIPMENT or its parts .................... 27
Table 201.C.104 – A CCOMPANYING DOCUMENTS , general ........................................................ 28
Table 201.C.105 – A CCOMPANYING DOCUMENTS , instructions for use ...................................... 28
Table 201.D.101 – Symbols for marking ENDOSCOPIC EQUIPMENT or its parts.......................... 29
Table BB.1 – Correspondence between this standard and GHTF/SG1/N41R9:2005 .............. 43

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 –4– 60601-2-18 © IEC:2009

INTERNATIONAL ELECTROTECHNICAL COMMISSION

____________

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-18: Particular requirements for the basic safety

and essential performance of endoscopic equipment

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to
technical committees; any IEC National Committee interested in the subject dealt with may participate in this
preparatory work. International, governmental and non-governmental organizations liaising with the IEC also
participate in this preparation. IEC collaborates closely with the International Organization for Standardization
(ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
iTeh STANDARD PREVIEW
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Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
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4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
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between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
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5) IEC provides no marking procedure5c6d90afefd4/iec-60601-2-18-2009
to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

International standard IEC 60601-2-18 has been prepared by IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62, Electrical equipment in medical
practice.

This third edition cancels and replaces the second edition, published in 1996, and its
Amendment 1 (2000). This edition constitutes a technical revision and has been aligned or
harmonized with IEC 60601-1:2005.

The main changes with respect to the previous edition include:

a) alignment of requirements with IEC 60601-1:2005;

b) inclusion of essential performance requirements;
c) the inclusion of energized endoscopes and energized endotherapy devices used through
second and subsequent punctures within the scope of the standard;
d) reference to IEC 60601-2-2 for the dielectric strength testing of HF energized endotherapy
devices, rather than defining different tests.
60601-2-18 © IEC:2009 –5–

The text of this particular standard is based on the following documents:

Enquiry draft Report on voting

62D/682/CDV 62D/743/RVC

Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

In this standard, the following print types are used:

– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.

– T ERMS DEFINED IN C LAUSE 3 OF THE GENERAL STANDARD , IN THIS PARTICULAR STANDARD OR AS

NOTED : SMALL CAPITALS .

In referring to the structure of this standard, the term

– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
–
iTeh STANDARD PREVIEW
“subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7). (standards.iteh.ai)
References to clauses within this standard are preceded by the term “Clause” followed by the
IEC 60601-2-18:2009
clause number. References to subclauses within this collateral standard are by number only.
https://standards.iteh.ai/catalog/standards/sist/e74a8019-9355-4b10-80f4-
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In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.

The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:

– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.

A list of all parts of the IEC 60601 series, published under the general title: Medical electrical
equipment, can be found on the IEC website.
 –6– 60601-2-18 © IEC:2009

The committee has decided that the contents of this publication will remain unchanged until
the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in
the data related to the specific publication. At this date, the publication will be

• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

IMPORTANT – The “colour inside” logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this publication using a colour printer.

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60601-2-18 © IEC:2009 –7–

INTRODUCTION

The minimum safety requirements specified in this particular standard are considered to
provide for a practical degree of safety in the operation of endoscopic equipment.

This particular standard amends and supplements IEC 60601-1 (third edition, 2005): Medical
electrical equipment – Part 1: General requirements for basic safety and essential
performance, hereinafter referred to as ‘the general standard’.

The requirements are followed by specifications for the relevant tests.

iTeh STANDARD PREVIEW

(standards.iteh.ai)
IEC 60601-2-18:2009
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 –8– 60601-2-18 © IEC:2009

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-18: Particular requirements for the basic safety

and essential performance of endoscopic equipment

201.1 Scope, object and related standards

Clause 1 of the general standard 1) applies, except as follows:

201.1.1 * Scope

Replacement:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
ENDOSCOPIC EQUIPMENT together with its INTERCONNECTION CONDITIONS and INTERFACE
CONDITIONS .

201.1.2 Object

Replacement:
iTeh STANDARD PREVIEW
The object of this particular standard is to establish particular and
BASIC SAFETY ESSENTIAL
PERFORMANCE requirements for (standards.iteh.ai) [as defined in 201.3.204].
ENDOSCOPIC EQUIPMENT

NOTE This object includes endoscopic intense IEC 60601-2-18:2009

light source equipment which is part of the ENDOSCOPIC
EQUIPMENT including https://standards.iteh.ai/catalog/standards/sist/e74a8019-9355-4b10-80f4-
its supply unit, therefore IEC 60601-2-57 does not apply.
5c6d90afefd4/iec-60601-2-18-2009
201.1.3 Collateral standards

Addition:

This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.

IEC 60601-1-2 applies as modified in Clause 202. IEC 60601-1-3 does not apply. All other
published collateral standards in the IEC 60601-1 series apply as published.

201.1.4 Particular standards

Replacement:

In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.

A requirement of a particular standard takes priority over the general standard.

For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.

—————————
1) The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance.
60601-2-18 © IEC:2009 –9–

The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are
specified by the use of the following words:

"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.

"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.

"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.

Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.

iTeh STANDARD PREVIEW

Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
(standards.iteh.ai)
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.

The term "this standard" is used to make IEC 60601-2-18:2009

reference to the general standard, any applicable
https://standards.iteh.ai/catalog/standards/sist/e74a8019-9355-4b10-80f4-
collateral standards and this particular standard taken together.
5c6d90afefd4/iec-60601-2-18-2009
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.

201.2 Normative references

Clause 2 of the general standard applies, except as follows:

Amendment:

IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests

Addition:

IEC 60601-2-2:2009, Medical electrical equipment – Part 2-2: Particular requirements for the
basic safety and essential performance of high frequency surgical equipment and high
frequency surgical accessories

IEC 60601-2-37, Medical electrical equipment – Part 2-37: Particular requirements for the
basic safety and essential performance of ultrasonic medical diagnostic and monitoring
equipment
 – 10 – 60601-2-18 © IEC:2009

ISO 8600-1, Optics and photonics – Medical endoscopes and endotherapy devices – Part 1:
General requirements

201.3 Terms and definitions

For the purposes of this document, the terms and definitions given in IEC 60601-1:2005
apply, except as follows:

NOTE An index of defined terms is found beginning on page 45.

Addition:

201.3.201
* CAPACITIVELY COUPLED HF CURRENT
unavoidable HIGH FREQUENCY current flowing due to capacitive coupling from an ENERGIZED
ENDOTHERAPY DEVICE that is the APPLIED PART of HF SURGICAL EQUIPMENT to the ENDOSCOPE

201.3.202
* CONFIGURATION FOR ENDOSCOPIC APPLICATION
combination of ENDOSCOPIC EQUIPMENT by means of INTERFACE CONDITIONS and/or
INTERCONNECTION CONDITIONS with one or more of the following:

– ENERGIZED ENDOTHERAPY DEVICE ( S )

– iTeh STANDARD PREVIEW

MEDICAL ELECTRICAL EQUIPMENT

– non- MEDICAL ELECTRICAL EQUIPMENT

– MEDICAL ELECTRICAL SYSTEM
(standards.iteh.ai)
NOTE Not all of the items in the CONFIGURATION FOR ENDOSCOPIC APPLICATION are included in the scope of this
IEC 60601-2-18:2009
particular standard. Seehttps://standards.iteh.ai/catalog/standards/sist/e74a8019-9355-4b10-80f4-
Figure AA.101 in Annex AA for a diagrammatic explanation.
5c6d90afefd4/iec-60601-2-18-2009
201.3.203
ENDOSCOPE
medical instrument having viewing means, with or without optics, introduced into a body cavity
through a natural or surgically created body opening for examination, diagnosis or therapy

[ISO 8600-1, definition 3.1]

NOTE 1 ENDOSCOPES may be of rigid, flexible or capsule type, each of which may have different image pick-up
systems (e.g. via lenses or electronic/ultrasonic sensors) and different image transmission systems (e.g. optical
(via lenses or fiber bundles), or electrical/electronic).

NOTE 2 NOTE 1 differs from NOTE 1 of definition 3.1 in ISO 8600-1 in order to include 'capsule' endoscopes.

201.3.204
ENDOSCOPIC EQUIPMENT
an ENERGIZED ENDOSCOPE together with its SUPPLY UNIT (s), as required for its INTENDED USE

201.3.205
ENDOTHERAPY DEVICE
medical device intended to be inserted into a natural or surgically created body opening
during endoscopic procedures, whether through the same or a different orifice from the
ENDOSCOPE , for examination, diagnosis or therapy

NOTE ENDOTHERAPY DEVICES include the instrument through which an ENDOSCOPE or ENDOTHERAPY DEVICE is
inserted, such as a guide tube, trocar tube or sliding tube, etc. ENDOTHERAPY DEVICES include the devices to be
inserted through openings other than the opening for an ENDOSCOPE , to ensure the safety of the devices for the
intended use under the endoscopic view.

[ISO 8600-1, definition 3.2]

60601-2-18 © IEC:2009 – 11 –

201.3.206
* ENERGIZED ENDOSCOPE
an ENDOSCOPE that is an APPLIED PART of ME EQUIPMENT using energy for producing the
internal view or image, for example illumination and signal processing

201.3.207
* ENERGIZED ENDOTHERAPY DEVICE
an ENDOTHERAPY DEVICE that is an APPLIED PART of ME EQUIPMENT , which may or may not be
ENDOSCOPIC EQUIPMENT , introduced into a PATIENT through the same orifice as the ENDOSCOPE ,
or through a second or subsequent orifice, using energy for providing its INTENDED USE , for
example HF currency, ultrasound and laser

201.3.208
HIGH FREQUENCY
HF
frequencies generally greater than 200 kHz

[IEC 60601-2-2:2009, definition 201.3.218]

201.3.209
HF SURGICAL EQUIPMENT
MEDICAL ELECTRICAL EQUIPMENT , including associated ACCESSORIES , intended for the
performance of surgical operations, such as the CUTTING or COAGULATION of biological tissue
by means of HIGH FREQUENCY currents
iTeh STANDARD PREVIEW
[IEC 60601-2-2:2009, definition 201.3.222]

201.3.210
(standards.iteh.ai)
INTERCONNECTION CONDITIONS
conditions that shall be fulfilled to IEC 60601-2-18:2009
achieve BASIC SAFETY when one or more ENERGIZED
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ENDOSCOPES are used simultaneously with one or more ENERGIZED ENDOTHERAPY DEVICES
5c6d90afefd4/iec-60601-2-18-2009
201.3.211
INTERFACE CONDITIONS
conditions that shall be fulfilled to achieve BASIC SAFETY for any FUNCTIONAL CONNECTION
between ENDOSCOPIC EQUIPMENT and other ME EQUIPMENT or non- ME EQUIPMENT in the
CONFIGURATION FOR ENDOSCOPIC EQUIPMENT

201.3.212
LIGHT EMISSION PART
that part of the insertion portion of an ENERGIZED ENDOSCOPE surrounding the light emission
window, delineated as follows:

the area of the surface of the insertion portion within three times the maximum diameter of the
insertion portion, measured at the tip (distal cover removed) for forward viewing ENERGIZED
ENDOSCOPES or the centre of the light emission window for side viewing ENERGIZED
ENDOSCOPES , measured in both longitudinal directions from the centre of the light emission
window, but with a minimum of 10 mm and a maximum of 25 mm. See also Figure 201.101.
 – 12 – 60601-2-18 © IEC:2009

L L D

Light Side viewing ENDOSCOPES

emission L=3×D
window
L Lmin = 10 mm

Lmax = 25 mm

D LIGHT EMISSION PART

is shown by shading

Forward viewing ENDOSCOPES

IEC 1483/09

Figure 201.101 – Identification of LIGHT EMISSION PART

201.3.213
NEUTRAL ELECTRODE
NE iTeh STANDARD PREVIEW
electrode of a relatively large area for connection to the body of the PATIENT , intended to
(standards.iteh.ai)
provide a return path for the HIGH FREQUENCY current with such a low current density in the
body tissue that physical effects such as unwanted burns are avoided
NOTE The NEUTRAL ELECTRODE is also known IEC 60601-2-18:2009
as plate, plate electrode, passive, return or dispersive electrode.
https://standards.iteh.ai/catalog/standards/sist/e74a8019-9355-4b10-80f4-
5c6d90afefd4/iec-60601-2-18-2009
[IEC 60601-2-2:2009, definition 201.3.227]

201.3.214
RATED ACCESSORY VOLTAGE
maximum peak HF output voltage which may be applied to a MONOPOLAR HF SURGICAL
ACCESSORY with respect to an NE connected to the PATIENT . For a BIPOLAR HF SURGICAL
ACCESSORY , the maximum peak HF output voltage which may be applied to pairs of opposite
polarity.

[IEC 60601-2-2:2009, definition 201.3.228]

201.3.215
* SUPPLY UNIT
that part of ME EQUIPMENT , directly connected to an ENDOSCOPE , supplying necessary functions
forming the ENERGIZED ENDOSCOPE

201.3.216
ULTRSONIC DIAGNOSTIC EQUIPMENT
MEDICAL ELECTRICAL EQUIPMENT that is intended for ultrasonic medical examination

[IEC 60601-2-37, definition 201.3.217]

201.4 General requirements

Clause 4 of the general standard applies, except as follows:

60601-2-18 © IEC:2009 – 13 –

201.4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS

Addition:

201.4.1.101 * Energized endotherapy devices

Where requirements for ENDOTHERAPY DEVICES given in other applicable particular standards
conflict with the requirements for INTERCONNECTION CONDITIONS of this particular standard, the
requirements of this particular standard shall take precedence.

201.4.1.102 Ultrasonic diagnostic equipment

For the ultrasonic safety aspects of ENDOSCOPIC EQUIPMENT which is also ULTRASONIC
DIAGNOSTIC EQUIPMENT , that part which is intended for ultrasonic diagnosis shall comply with
the requirements of IEC 60601-2-37 and the other parts shall comply with the requirements of
this particular standard.

201.4.1.103 * S UPPLY UNITS

For SUPPLY UNITS providing a plurality of functions where different particular standards apply,
the appropriate parts of these shall comply with the requirements of the relevant particular
standards.

201.4.3 E SSENTIAL PERFORMANCE

Addition: iTeh STANDARD PREVIEW

201.4.3.101 * Additional
(standards.iteh.ai)
requirements
ESSENTIAL PERFORMANCE

Additional ESSENTIAL PERFORMANCE requirementsIEC 60601-2-18:2009 are found in the subclauses listed in
Table 201.101. https://standards.iteh.ai/catalog/standards/sist/e74a8019-9355-4b10-80f4-
5c6d90afefd4/iec-60601-2-18-2009
Table 201.101 – List of ESSENTIAL PERFORMANCE requirements

Requirement Subclause
To that there is no unacceptable RISK if the view observed by the Applicability
OPERATOR has an unexpected image orientation. and condition
as defined by
manufacturer
To ensure that there is no unacceptable RISK , if there is a lack of, or 201.12.4.4
significant error in, provision of a particular spectral output or frequency
necessary to provide accurate diagnosis or therapy, which is not identifiable
by a trained OPERATOR.
To ensure that there is no unacceptable RISK that the OPERATOR is viewing 201.13.1.101
the live image during an endoscopic procedure, rather than a recorded
image.

NOTE See 201.7.9.2.2 g) for warning and safety notices related to the ESSENTIAL PERFORMANCE requirements.

201.4.6 * M E EQUIPMENT or ME SYSTEM PARTS that contact the PATIENT

Addition:

Light guide cables are treated as ME SYSTEM parts that CONTACT the PATIENT for the purposes
of this particular standard, unless the RISK MANAGEMENT FILE indicates otherwise for specific
configurations.

Compliance is checked by inspection of the RISK MANAGEMENT FILE .