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I.S. EN 60601-2-22:2013

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 2-22: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SURGICAL, COSMETIC, THERAPEUTIC AND DIAGNOSTIC LASER EQUIPMENT (IEC 60601-2-22:2007 (EQV) + A1:2012 (EQV))
Available format(s)

Hardcopy , PDF

Superseded date

11-24-2020

Language(s)

English

Published date

02-26-2013

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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 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
Annexes
Annex D (informative) - Symbols on marking
Annex AA (informative) - Particular guidance and rationale
Bibliography
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

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of laser equipment for either surgical, therapeutic, medical diagnostic, cosmetic, or veterinary applications, intended for its use on humans or animals, classified as a CLASS 3B or CLASS 4 LASER PRODUCT as defined by 3.22 and 3.23 in IEC 60825-1, hereafter referred to as LASER EQUIPMENT.

Committee
TC 76
DevelopmentNote
For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
DocumentType
Standard
Pages
34
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
NF EN 60601-2-22 : 2013 Identical
DIN EN 60601-2-22 : 2015 Identical
SN EN 60601-2-22 : 1996 Identical
EN 60601-2-22:2013 Identical
UNE-EN 60601-2-22:1997 Identical
BS EN 60601-2-22:2013 Identical

EN 60825-1:2014/AC:2017-06 SAFETY OF LASER PRODUCTS - PART 1: EQUIPMENT CLASSIFICATION AND REQUIREMENTS (IEC 60825-1:2014)
IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
EN 60947-3:2009/A2:2015 LOW-VOLTAGE SWITCHGEAR AND CONTROLGEAR - PART 3: SWITCHES, DISCONNECTORS, SWITCH-DISCONNECTORS AND FUSE-COMBINATION UNITS (IEC 60947-3:2008/A2:2015)
IEC TR 60825-14:2004 Safety of laser products - Part 14: A user's guide
IEC 60664-3:2016 Insulation coordination for equipment within low-voltage systems - Part 3: Use of coating, potting or moulding for protection against pollution
IEC 60947-3:2008+AMD1:2012+AMD2:2015 CSV Low-voltage switchgear and controlgear - Part 3: Switches, disconnectors, switch-disconnectors and fuse-combination units
EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements

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