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CSA C22.2 No. 60601.2.18 : 20111

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MEDICAL ELECTRICAL EQUIPMENT - PART 2-18: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ENDOSCOPIC EQUIPMENT
Available format(s)

Hardcopy , PDF

Superseded date

07-09-2021

Language(s)

English

Published date

01-01-2016

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 labeling
        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)
Bibliography
Index of defined terms used in this particular standard

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ENDOSCOPIC EQUIPMENT together with its INTERCONNECTION CONDITIONS and INTERFACE CONDITIONS.

DocumentType
Standard
Pages
120
ProductNote
Reconfirmed EN
PublisherName
Canadian Standards Association
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
IEC 60601-2-18:2009 Identical

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
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
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

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