BS EN 60601-2-16 ED 5.0 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT

Available format(s)

Hardcopy , PDF

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 for ME EQUIPMENT
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
208 General requirements, tests and guidance for
    ALARM SYSTEMS in MEDICAL ELECTRICAL
    EQUIPMENT and MEDICAL ELECTRICAL
    SYSTEMS
209 Requirements for environmentally conscious
    design
210 Process requirements for the development of
    PHYSIOLOGIC CLOSED-LOOP CONTROLLERS
211 Requirements for MEDICAL ELECTRICAL
    EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS
    used in the HOME HEALTHCARE ENVIRONMENT
Annexes
Annex G (normative) - Protection against HAZARDS
        of ignition of flammable anaesthetic mixtures
Annex AA (informative) - Particular guidance and
         rationale
Annex BB (informative) - Examples of HAZARDS,
         foreseeable sequences of events, and HAZARDOUS
         SITUATIONS in HAEMODIALYSIS EQUIPMENT
Bibliography
Index of defined terms used in this particular standard

BS EN 60601-2-16 Ed 5.0.

Committee	CH/150/2
DocumentType	Draft
Pages	74
PublisherName	British Standards Institution
Status	NA

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