IEC 60601-2-18:2009

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.

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.

General Information

• Status: Published
• Publication Date: 11-Aug-2009
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: MT 16 - TC 62/SC 62D/MT 16
• Current Stage: PPUB - Publication issued
• Start Date: 31-Oct-2009
• Completion Date: 12-Aug-2009

Relations

• Revises: IEC 60601-2-18:1996 - Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-18:1996/AMD1:2000 - Amendment 1 - Medical electrical equipment - Part 2-18: Particular requirements for the safety of endoscopic equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

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

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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
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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.

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