CSA C22.2 No. 60601-2-57:2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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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
Hardcopy , PDF
28-07-2021
English
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 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Superseded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 |
| 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 |
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