SIST EN 60601-2-18:2015

Medical electrical equipment -- Part 2-18: Particular requirements for basic safety and essential performance of endoscopic equipment

IEC 60601-2-18:2009 establishes particular basic safety and essential performance requirements for endoscopic equipment. 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. IEC 60601-2-18:2009 amends and supplements IEC 60601-1:2005. 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:  - alignment of requirements with IEC 60601-1:2005;  - inclusion of essential performance requirements;  - the inclusion of energized endoscopes and energized endotherapy devices used through second and subsequent punctures within the scope of the standard;  - reference to IEC 60601-2-2 for the dielectric strength testing of HF energized endotherapy devices, rather than defining different tests.

Medizinische elektrische Geräte - Teil 2-18: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von endoskopischen Geräten

Appareils électromedicaux -- Partie 2-18: Exigences particulières pour la sécurité de base et les performances essentielles des appareils d’endoscopie

La CEI 60601-2-18:2009 établit les exigences particulières pour la sécurité de base et les performances essentielles des appareils d'endoscopie. Les exigences de sécurité minimales spécifiées dans la présente norme particulière fournissent un degré de sécurité pratique pour le fonctionnement des appareils d'endoscopie. La CEI 60601-2-18:2009 modifie et complète la CEI 60601-1:2005. Cette troisième édition annule et remplace la deuxième édition, publiée en 1996 et son Amendement 1 (2000). Cette édition constitue une révision technique et est alignée ou harmonisée avec la CEI 60601-1:2005. Les modifications principales par rapport à l'édition précédente sont les suivantes:  - l'alignement des exigences avec la CEI 60601-1-2005;  - l'inclusion des exigences relatives aux performances essentielles;  - l'inclusion des endoscopes alimentés et des appareils d'endothérapie alimentés utilisés pour des ponctions secondaires et ultérieures dans le cadre du domaine d'application de la norme;  - la référence à la CEI 60601-2-2 pour les essais de tension de tenue des appareils d'endothérapie alimentés par courant HF, plutôt que la définition d'essais différents.

Medicinska električna oprema - 2-18. del: Posebne zahteve za osnovno varnost in bistvene lastnosti endoskopske opreme

IEC 60601-2-18:2009 vzpostavlja posebne zahteve glede osnovne varnosti in bistvenih lastnosti endoskopske opreme. Minimalne varnostne zahteve, navedene v tem standardu, se uporabljajo za določitev praktične stopnje varnosti pri upravljanju endoskopske opreme. IEC 60601-2-18:2009 dopolnjuje in izpolnjuje IEC 60601-1:2005. Ta tretja izdaja razveljavlja in nadomešča drugo izdajo, objavljeno leta 1996, ter njeno dopolnilo 1 (2000). Ta izdaja tvori tehnično popravljeno izdajo in je usklajena ali harmonizirana s standardom IEC 60601-1:2005. Glavne spremembe glede na predhodno različico: – uskladitev zahtev s standardom IEC 60601-1:2005; – vključitev zahtev glede bistvenih lastnosti; –vključitev endoskopov z napajanjem ter endoterapevtskih naprav z napajanjem, ki se uporabljajo pri sekundarnem predrtju in naslednjih predrtjih znotraj področja uporabe tega standarda; – sklic na IEC 60601-2-2 za preskušanje dielektrične moči endoterapevtskih naprav HF z napajanjem namesto določevanja različnih preskusov.

General Information

• Status: Published
• Publication Date: 09-Nov-2015
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 05-Nov-2015
• Due Date: 10-Jan-2016
• Completion Date: 10-Nov-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: TRRTP129 - Tehnična smernica TSG-12640-001:2008 Zdravstveni objekti
• Ref Project: EN 60601-2-18:2015 - Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

Relations

• Replaces: SIST EN 60601-2-18:1998 - Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment (IEC 60601-2-18:1996)
• Effective Date: 01-Dec-2015
• Replaces: SIST EN 60601-2-18:1998/A1:2002 - Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment (IEC 60601-2-18:1996/A1:2000)
• Effective Date: 01-Dec-2015

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2015
1DGRPHãþD
SIST EN 60601-2-18:1998
SIST EN 60601-2-18:1998/A1:2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLHQGRVNRSVNHRSUHPH
Medical electrical equipment -- Part 2-18: Particular requirements for basic safety and
essential performance of endoscopic equipment
Medizinische elektrische Geräte - Teil 2-18: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von endoskopischen Geräten
Appareils électromedicaux -- Partie 2-18: Exigences particulières pour la sécurité de
base et les performances essentielles des appareils d’endoscopie
Ta slovenski standard je istoveten z: EN 60601-2-18:2015
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-2-18

NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2015
ICS 11.040.50 Supersedes EN 60601-2-18:1996
English Version
Medical electrical equipment - Part 2-18: Particular requirements
for the basic safety and essential performance of endoscopic
equipment
(IEC 60601-2-18:2009)
Appareils électromédicaux - Partie 2-18: Exigences Medizinische elektrische Geräte - Teil 2-18: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils d'endoscopie wesentlichen Leistungsmerkmale von endoskopischen
(IEC 60601-2-18:2009) Geräten
(IEC 60601-2-18:2009)
This European Standard was approved by CENELEC on 2015-09-15. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-18:2015 E
European foreword
The text of document 62D/682/CDV, future edition 3 of IEC 60601-2-18, prepared by SC 62D
"Electromedical equipment", of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-18:2015.
The following dates are fixed:
(dop) 2016-06-15
• latest date by which the document has to be implemented at
national level by publication of an identical national
standard or by endorsement
(dow) 2018-09-15
• latest date by which the national standards conflicting with
the document have to be withdrawn

This document supersedes EN 60601-2-18:1996.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part
of this document.
Endorsement notice
The text of the International Standard IEC 60601-2-18:2009 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standard indicated :
IEC 60601-2-57 NOTE Harmonized as EN 60601-2-57.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
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.
NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is
available here: www.cenelec.eu.

Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Replacement in Annex ZA of EN 60601-1:2006:
IEC 60601-1-2 (mod) 2007 Medical electrical equipment - EN 60601-1-2 2007
Part 1-2: General requirements for basic
- -  + corrigendum Mar. 2010
safety and essential performance -
Collateral standard: Electromagnetic
compatibility - Requirements and tests
Addition to Annex ZA of EN 60601-1:2006:
IEC 60601-2-2 2009 Medical electrical equipment - EN 60601-2-2 2009
Part 2-2: Particular requirements for the
- -  + A11 2011
basic safety and essential performance
of high frequency surgical equipment and
high frequency surgical accessories
IEC 60601-2-37 -  Medical electrical equipment - EN 60601-2-37 -
Part 2-37: Particular requirements for the
basic safety and essential performance
of ultrasonic medical diagnostic and
monitoring equipment
ISO 8600-1 -  Optics and photonics - Medical - -
endoscopes and endotherapy devices -
Part 1: General requirements
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and within its scope the Standard covers all
relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993
concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling within
the scope of this standard.
IEC 60601-2-18 ®
Edition 3.0 2009-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-18: Particular requirements for the basic safety and essential
performance of endoscopic equipment

Appareils électromédicaux –
Partie 2-18: Exigences particulières pour la sécurité de base et les
performances essentielles des appareils d'endoscopie
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
X
CODE PRIX
ICS 11.040.50 ISBN 978-2-88910-216-7
– 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 ME 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 HAZARDOUS SITUATIONS and fault conditions.25
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .25
201.15 Construction of ME EQUIPMENT .25
201.16 ME SYSTEMS .26
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .26
202 Electromagnetic compatibility – Requirements and tests .26

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 – ACCOMPANYING DOCUMENTS, general .28
Table 201.C.105 – ACCOMPANYING 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

– 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
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure 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.
– TERMS DEFINED IN CLAUSE 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.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this collateral standard are by number only.
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.

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.

– 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
1)
Clause 1 of the general standard 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:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for ENDOSCOPIC EQUIPMENT [as defined in 201.3.204].
NOTE This object includes endoscopic intense light source equipment which is part of the ENDOSCOPIC
EQUIPMENT including its supply unit, therefore IEC 60601-2-57 does not apply.
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.
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
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
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)
– MEDICAL ELECTRICAL EQUIPMENT
– non-MEDICAL ELECTRICAL EQUIPMENT
– MEDICAL ELECTRICAL SYSTEM
NOTE Not all of the items in the CONFIGURATION FOR ENDOSCOPIC APPLICATION are included in the scope of this
particular standard. See Figure AA.101 in Annex AA for a diagrammatic explanation.
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
[IEC 60601-2-2:2009, definition 201.3.222]
201.3.210
INTERCONNECTION CONDITIONS
conditions that shall be fulfilled to achieve BASIC SAFETY when one or more ENERGIZED
ENDOSCOPES are used simultaneously with one or more ENERGIZED ENDOTHERAPY DEVICES
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
D
Light Side viewing ENDOSCOPES
L = 3 × D
emission
window
L = 10 mm
L
min
L = 25 mm
max
LIGHT EMISSION PART
D
is shown by shading
Forward viewing ENDOSCOPES
IEC  1483/09
Figure 201.101 – Identification of LIGHT EMISSION PART
201.3.213
NEUTRAL ELECTRODE
NE
electrode of a relatively large area for connection to the body of the PATIENT, intended to
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 as plate, plate electrode, passive, return or dispersive electrode.
[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 * SUPPLY 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 ESSENTIAL PERFORMANCE
Addition:
201.4.3.101 * Additional ESSENTIAL PERFORMANCE requirements
Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in
Table 201.101.
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.

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

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201.4.7 SINGLE FAULT CONDITION for ME EQUIPMENT
Addition:
To be SINGLE FAULT SAFE, the INTERCONNECTION CONDITIONS and INTERFACE CONDITIONS as
defined by the MANUFACTURER shall be taken into account as part of the RISK MANAGEMENT
process.
Compliance is checked by inspection of the RISK MANAGEMENT FILE.
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.1 TYPE TESTS
Addition:
The definition of ENERGIZED ENDOSCOPE necessarily includes ENDOSCOPES that are energized
only by light energy and for which the required F-TYPE APPLIED part isolation is provided in the
SUPPLY UNIT. Under these conditions, there is no unacceptable electrical RISK for the PATIENT
or OPERATOR. Therefore there is no need to conduct electrical safety TYPE TESTS, such as
those detailed in Clause 8.
201.5.7 * Humidity preconditioning treatment
Addition:
ACCESS COVERS of ENDOSCOPIC EQUIPMENT which can be opened without the use of a TOOL,
but which inactivate the EQUIPMENT (e.g. by an interlock) once opened, may remain closed
and/or attached during humidity preconditioning unless the RISK MANAGEMENT process
suggests that the ENDOSCOPIC EQUIPMENT can be exposed to high humidity during the periods
ACCESS COVERS are opened.
when
ENERGIZED ENDOSCOPES and ENERGIZED ENDOTHERAPY DEVICES which according to their
intended use or instructions for use are subject to disinfection and/or sterilization processes
prior to use are excluded from humidity preconditioning treatment according to this subclause,
but shall instead be subjected to subclauses 11.6.6 and/or 11.6.7 of the general standard, as
appropriate, prior to any relevant tests.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies, except as follows:
201.6.2 Protection against electric shock
Replacement of final paragraph:
APPLIED PARTS of ENDOSCOPIC EQUIPMENT shall be classified as TYPE BF APPLIED PARTS or TYPE
CF APPLIED PARTS (see 8.3). These APPLIED PARTS may be classified as DEFIBRILLATION-PROOF
APPLIED PARTS.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:

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201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
201.7.2.1 Minimum requirements for marking on ME EQUIPMENT and on
interchangeable parts
Replacement:
If the size of the ME EQUIPMENT, an ME EQUIPMENT part or an ACCESSORY, or the nature of its
ENCLOSURE, does not allow affixation of all markings specified in 7.2.2 to 7.2.20 (inclusive) of
the general standard, then at least the markings as indicated in 7.2.2, 7.2.5, 7.2.6 (not for
PERMANENTLY INSTALLED ME EQUIPMENT), 7.2.10 and 7.2.13 (if applicable) of the general
standard shall be affixed and the remaining markings shall be recorded in full in the
ACCOMPANYING DOCUMENTS. Where no marking of the ME EQUIPMENT or ACCESSORY is
practicable, these markings may be affixed to the individual packaging.
Any material, component, ACCESSORY or ME EQUIPMENT that is intended for a single use or its
packaging shall be marked “Do Not Reuse” or with symbol ISO 7000-1051 (2004-01) (see
Table D.1, symbol 28 of the general standard).
201.7.2.9 * IP classification
Addition:
ENERGIZED ENDOSCOPES and ENERGIZED ENDOTHERAPY DEVICES supplied with specific
instructions detailing allowable reprocessing methods and parameters are excluded from this
requirement. No symbol is required to identify the reprocessing procedure by this particular
standard. See also subclause 7.9.2.12 of the general standard.
201.7.2.10 APPLIED PARTS
Addition:
Where no marking of an APPLIED PART is practicable, the required marking may be affixed to
the individual packaging.
Compliance is checked by inspection.
Additional subclauses:
201.7.2.101 Alternative marking
Information, which is accessible by the user on an output device (e.g. display) of ENDOSCOPIC
EQUIPMENT is considered equivalent to marking on the EQUIPMENT for requirements 7.2.3,
7.2.5, 7.2.11 and 7.2.13 of the general standard, as long as the marking is visible at the time
the information is required.
Compliance is checked by inspection of the results of the USABILITY ENGINEERING process
and / or by inspection of the ACCOMPANYING DOCUMENTS.
201.7.2.102 * Illumination lamps
SUPPLY UNITS having replaceable illumination lamps accessible without the use of a TOOL shall
be provided with permanently affixed and clearly legible markings near the lamps, either
inside or outside the SUPPLY UNIT, giving the MODEL OR TYPE REFERENCE (preferably by use of
the symbol 111 of Table 201.D.101).
For replaceable illumination lamps built into the distal end of ENDOSCOPES, the MODEL OR TYPE
REFERENCE shall be stated in the ACCOMPANYING DOCUMENTS as a minimum.

– 16 – 60601-2-18 © IEC:2009
For replaceable illumination lamps accessible only by SERVICE PERSONNEL with the use of a
TOOL, the MODEL OR TYPE REFERENCE shall be stated in the ACCOMPANYING DOCUMENTS as a
minimum.
201.7.4 Marking of controls and instruments
201.7.4.3 Units of measure
Addition:
For ENDOSCOPES and ENDOTHERAPY DEVICES, the measure 'French' or 'Charrière', symbol F
,
r
may be used to indicate the size of certain circular or non-circular cross-sections, defined as:
F = 3u/π
r
where u is the perimeter of the cross-section, expressed in mm.
NOTE Taken from ISO 8600-1.
201.7.6 Symbols
201.7.6.2 Symbols from Annex D
Addition:
At the option of the MANUFACTURER, symbols to denote certain functions of ENDOSCOPIC
EQUIPMENT may be used, but if used shall be explained in the instructions for use. If symbols
are used, Appendix D lists those preferred symbols, which may be used to denote the
functions described.
201.7.9 ACCOMPANYING DOCUMENTS
201.7.9.2 Instructions for use
201.7.9.2.2 * Warning and safety notices
Addition:
The instructions for use of ENDOSCOPIC EQUIPMENT shall include the following warning and
safety notices where appropriate:
Warning and safety notices regarding ENDOSCOPIC EQUIPMENT:
APPLIED PART are likely to exceed 41 ºC (see also
a) Warnings if surface temperatures on an
201.11.1.2.2).
b) Warnings that high energy radiated light may be transmitted from the light emission
window of the ENDOSCOPE, giving rise to high temperatures in front of the light emission
RISKS.
window, and advice on how to minimize associated
c) Prevention of unacceptable RISKS if ENDOSCOPIC EQUIPMENT loses functions.
HAZARDOUS SITUATIONS, WHICH MAY CAUSE HARM, SUCH AS, burns and eye
d) Prevention of
damage, by the replacement of the illumination lamp.
e) Warning that the TYPE F APPLIED PART status of ENERGIZED ENDOSCOPES intended for use
with a multiplicity of SUPPLY UNITS and/or light guide cables is ensured by, for instance,
SUPPLY UNITS having isolated light guide output sockets.
using only
f) That before each use, the outer surface of the portions of ENERGIZED ENDOSCOPES which
are intended to be inserted into a PATIENT should be checked to ensure there are no
unintended rough surfaces, sharp edges or protrusions which may cause HARM.

60601-2-18 © IEC:2009 – 17 –
g) That before each use or after a change of viewing modes / settings, the OPERATOR should
check to ensure the view observed through the ENDOSCOPE provides a live image (rather
than a stored one) and has the correct image orientation.
Warning and safety notices regarding INTERCONNECTIONS CONDITIONS:
h) Warning that INTERCONNECTIONS CONDITIONS require the APPLIED PARTS of other ME
EQUIPMENT used within the CONFIGURATION FOR ENDOSCOPIC APPLICATION to be TYPE BF
APPLIED PARTS or TYPE CF APPLIED PARTS.
i) Warnings regarding RISKS resulting from gas embolism caused by, for example, over-
insufflation of air, inert gas prior to HIGH FREQUENCY surgery, or laser assist gas.
j) Warnings that when ENERGIZED ENDOSCOPES are used with ENERGIZED ENDOTHERAPY
DEVICES, PATIENT LEAKAGE CURRENTS may be additive. It should be noted that this is
particularly important if a TYPE CF APPLIED PART ENDOSCOPE is used, in which case a TYPE
CF APPLIED PART ENERGIZED ENDOTHERAPY DEVICE should be used in order to minimize total
PATIENT LEAKAGE CURRENT.
k) Avoidance of risks in the event of explosive gas concentrations being present in the area
of use of HF ENERGIZED ENDOTHERAPY DEVICES.
l) When ENERGIZED ENDOSCOPES and/or ENERGIZED ENDOTHERAPY DEVICEs is/are used with
laser equipment, advice concerning their safe use shall be given, including avoidance of
potential eye damage to the OPERATOR by, for example, wearing suitable protective
filtering spectacles, or by inserting a suitable filter in the eyepiece of the ENERGIZED
ENDOSCOPE.
m) That before each use, the compatibility of the ENDOSCOPIC EQUIPMENt with any
ACCESSORIES and/or ENERGIZED ENDOTHERAPY DEVICES should be checked according to any
criteria for safe use defined in the instructions for use.
n) That before each use, the outer surface of the portions of any ENERGIZED ENDOTHERAPY
DEVICES which are intended to be inserted into a PATIENT should be
...