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BS EN 60601-2-66 ED.2 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS

Available format(s)

Hardcopy , PDF

Superseded date

12-31-2015

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 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
Annexes
Annex E (informative) - Examples of the connection of the
        measuring device (MD) for measurement of the
        PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT
Annex G (normative) - Protection against HAZARDS of
        ignition of flammable anaesthetic mixtures
Annex H (informative) - PEMS structure, PEMS
        DEVELOPMENT LIFE-CYCLE and documentation
Annex I (informative) - ME SYSTEMS aspects
Annex J (informative) - Survey of insulation paths
Annex K (informative) - Simplified PATIENT LEAKAGE
        CURRENT diagrams
Annex L (normative) - Insulated winding wires for use
        without interleaved insulation
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Abbreviations
Bibliography
Index of defined terms used in this particular standard

BS EN 60601-2-66 Ed.2.

Committee	EPL/29
DocumentType	Draft
Pages	43
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN 60601-2-66:2015

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