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I.S. EN 60601-2-57:2011

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Current

The latest, up-to-date edition.

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
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2011

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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 AA (informative) - Particular guidance and
         rationale
Annex BB (informative) - Exposure limit values
Annex CC (informative) - Protective eyewear for LS
         EQUIPMENT
Annex DD (informative) - Summary of MANUFACTURER'S
         requirements
Annex EE (informative) - Symbols on marking
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

Applicable to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment incorporating one or more sources of OPTICAL RADIATION in the wavelength range 200 nm to 3000 nm, with the exception of laser radiation, and intended to create non-visual photobiological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment (LS 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
43
PublisherName
National Standards Authority of Ireland
Status
Current

Standards Relationship
IEC 60601-2-57:2011 Identical
EN 60601-2-57:2011 Identical

BS 8497-1:2008 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications Specification for products
ISO 3864-2:2016 Graphical symbols — Safety colours and safety signs — Part 2: Design principles for product safety labels
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 60878:2015 Graphical symbols for electrical equipment in medical practice
IEC 62471:2006 Photobiological safety of lamps and lamp systems
BS 8497-2:2008 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications Guidance on use
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 62471:2008 Photobiological safety of lamps and lamp systems

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