CSA C22.2 No. 60601-2-57:2011

Name: CSA C22.2 No. 60601-2-57:2011
Brand: CSA

Superseded

View Superseded by

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

Superseded date

07-28-2021

Language(s)

English

Published date

01-01-2016

Publisher

Canadian Standards Association

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

Pertains 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).

DocumentType	Standard
Pages	94
ProductNote	Reconfirmed EN
PublisherName	Canadian Standards Association
Status	Superseded
SupersededBy	CSA C22.2 No. 60601-2-57 : 2011 : R2016

Standards	Relationship
IEC 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
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