09/30165797 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN 60601-2-57 ED.1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-57: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF NON-LASER LIGHT SOURCE EQUIPMENT INTENDED FOR THERAPEUTIC, DIAGNOSTIC, MONITORING AND COSMETIC/AESTHETIC USE
Hardcopy , PDF
30-06-2011
English
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
206 Usability
Annex AA (informative) - Description of risk groups of LS
Equipment Rationale
Annex BB (normative) - Exposure Limit Values
Annex CC (informative) - Protective eyewear for LS Equipment
Rationale
Annex DD (informative) - Table DD.1 - Summary of
manufacturer's requirements
Annex EE (informative) - Symbols on marking
Bibliography
Index of defined terms used in this particular standard
BS EN 60601-2-57 ED.1
Committee |
EPL/76
|
DocumentType |
Draft
|
Pages |
35
|
PublisherName |
British Standards Institution
|
Status |
Superseded
|
SupersededBy |
EN 14255-2:2005 | Measurement and assessment of personal exposures to incoherent optical radiation - Part 2: Visible and infrared radiation emitted by artificial sources in the workplace |
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 60825-1:2014 | Safety of laser products - Part 1: Equipment classification and requirements |
EN 165:2005 | Personal eye-protection - Vocabulary |
EN 166:2001 | Personal eye-protection - Specifications |
EN 14255-1:2005 | Measurement and assessment of personal exposures to incoherent optical radiation - Part 1: Ultraviolet radiation emitted by artificial sources in the workplace |
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 |
ISO 3864-1:2011 | Graphical symbols Safety colours and safety signs Part 1: Design principles for safety signs and safety markings |
EN 12198-1:2000+A1:2008 | Safety of machinery - Assessment and reduction of risks arising from radiation emitted by machinery - Part 1: General principles |
ANSI Z87.1 : 2015 | OCCUPATIONAL AND EDUCATIONAL PERSONAL EYE AND FACE PROTECTION DEVICES |
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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