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09/30165797 DC : 0

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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
Available format(s)

Hardcopy , PDF

Superseded date

06-30-2011

Language(s)

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Superseded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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