EN 60601-2-18:2015

Medical electrical equipment - Part 2-18: Particular requirements for the 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 électromédicaux - 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: 22-Oct-2015
• Withdrawal Date: 14-Sep-2018
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 23-Oct-2015
• Completion Date: 23-Oct-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 60601-2-18:2015 - Medical electrical equipment -- Part 2-18: Particular requirements for basic safety and essential performance of endoscopic equipment

Relations

• Replaces: EN 60601-2-18:1996 - Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment
• Effective Date: 29-Jan-2023
• Replaces: EN 60601-2-18:1996/A1:2000 - Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment
• Effective Date: 29-Jan-2023

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
...