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EN 60601-2-18:2015

Current
Current

The latest, up-to-date edition.

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

10-23-2015

Publisher

European Committee for Standards - Electrical

FOREWORD
INTRODUCTION
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and
       documents
201.8 Protection against electrical HAZARDS from
       ME EQUIPMENT
201.9 Protection against MECHANICAL HAZARDS of
       ME EQUIPMENT and ME SYSTEMS
201.10 Protection against unwanted and excessive
       radiation HAZARDS
201.11 Protection against excessive temperatures and
       other HAZARDS
201.12 Accuracy of controls and instruments and protection
       against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL
       SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT
       and ME SYSTEMS
202 Electromagnetic compatibility - Requirements and tests
Annexes
Annex C (informative) - Guide to marking and labelling
        requirements for ME EQUIPMENT and ME SYSTEMS
Annex D (informative) - Symbols on marking
Annex J (informative) - Survey of insulation paths
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Clauses of this standard
         addressing essential principles of safety and
         performance of medical devices
         (GHTF/SG1/N41R9:2005)
Index of defined terms used in this particular standard
Annex ZA (normative) - Normative references to
         international publications with their
         corresponding European publications
Annex ZZ (informative) - Coverage of Essential
         Requirements of EU Directives

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.

Committee
CLC/TC 62
DocumentType
Standard
PublisherName
European Committee for Standards - Electrical
Status
Current

BS EN 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 60601-2-37:2007+AMD1:2015 CSV Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
IEC 60601-2-57:2011 Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
ISO 8600-1:2015 Endoscopes — Medical endoscopes and endotherapy devices — Part 1: General requirements
EN 60601-2-57:2011 Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-2-2:2017 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
EN 60601-2-37:2008/A1:2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

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