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BS EN ISO 80601-2-72 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS

Available format(s)

Hardcopy , PDF

Superseded date

09-30-2015

Language(s)

English

Publisher

British Standards Institution

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
201.101 Gas connections
201.102 Requirements for the VBS and ACCESSORIES
201.103 Spontaneous breathing during loss of power supply
201.104 Training
201.105 Indication of duration of operation
201.106 FUNCTIONAL CONNECTION
201.107 Display loops
201.108 POWER SUPPLY CORDS
201.109 VENTILATOR security
202 Medical electrical equipment - Part 1-2: General
   requirements for basic safety and essential performance -
    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 basic safety and essential performance -
    Collateral Standard: General requirements, tests and
    guidance for alarm systems in medical electrical equipment
    and medical electrical systems
211 Medical electrical equipment - Part 1-11: General
    requirements for basic safety and essential performance -
    Collateral Standard: Requirements for medical electrical
    equipment and medical electrical systems used in the home
    healthcare environment
Annex C (informative) - Guide to marking and labeling
        requirements for ME EQUIPMENT and ME SYSTEMS
Annex D (informative) - Symbols on marking
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Data interface requirements
Annex CC (informative) - Reference to the Essential Principles
Bibliography
Alphabetized index of defined terms used in this particular
standard
Annex ZA (informative) - Relationship between this Document
         and the Essential Requirements of EU Directive
         93/42/EEC

BS EN ISO 80601-2-72

Committee	CH/121/5
DocumentType	Draft
Pages	95
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN ISO 80601-2-72:2015

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