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14/30281087 DC : 0

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Status of Standard is Unknown

BS EN 80601-2-71 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-71: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF FUNCTIONAL NEAR-INFRARED SPECTROSCOPY (NIRS) EQUIPMENT
Available format(s)

Hardcopy , PDF

Language(s)

English

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
202 Medical electrical equipment - Part 1-2: General
    requirements for safety - Collateral standard:
    Electromagnetic compatibility - Requirements
    and tests
206 Medical electrical equipment - Part 1-6: General
    requirements for basic safety and essential
    performance - Collateral Standard: Usability
208 Medical electrical equipment - Part 1-8: General
    requirements for safety - Collateral Standard:
    General requirements, tests and guidance
    for alarm systems in medical electrical equipment
    and medical electrical systems
209 Medical electrical equipment - Part 1-9: General
    requirements for safety - Collateral Standard:
    Requirements for environmentally conscious
    design
Annex C (informative) - Guide to marking and labeling
        requirements for ME EQUIPMENT and ME SYSTEMS
Annex AA (informative) - Particular guidance and rationale
Annex BB (Normative) - Evaluating me equipment performance
         using the phantom
Annex CC (informative) - Reference to the essential principles
Bibliography
Index of defined terms

BS EN 80601-2-71.

Committee
CH/62/4
DocumentType
Draft
Pages
41
PublisherName
British Standards Institution
Status
NA

IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-9:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

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