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10/30240267 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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

BS EN 60601-2-66 ED.1 - ELECTROACOUSTICS - PART 2-66: HEARING INSTRUMENTS AND HEARING SYSTEMS - GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE

Available format(s)

Hardcopy , PDF

Superseded date

28-02-2013

Superseded by

BS EN 60601-2-66:2015

Language(s)

English

€23.37
Excluding VAT

201.1 Scope, object and related standards
201.2 Normative references
201.3 Terminology 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
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT and ME SYSTEMS
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
203 Medical electrical equipment - Part 1: General
    requirements for safety - 3 Collateral standard: General
    requirements for radiation protection in diagnostic Xray
    equipment
206 Medical electrical equipment - Part 1-6: General
    requirements for safety - 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: Medical electrical
    equipment - General requirements for basic safety and
    essential performance - Collateral Standard: Requirements
    for the reduction of environmental impacts
210 Medical electrical equipment - Part 1-10: Medical electrical
    equipment - General requirements for basic safety and
    essential performance - Collateral Standard: Process
    requirements for the development of therapeutic closed-loop
    controllers
211 Medical electrical equipment - Part 1-11: General
    requirements for basic safety and essential performance -
    Collateral Standard: Process Requirements for medical
    electrical equipment and medical electrical systems used
    in the home healthcare environment
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Abbreviations
Index of defined terms used in this particular standard

BS EN 60601-2-66 ED.1

Committee
EPL/29
DocumentType
Draft
Pages
41
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

IEC 60318-4:2010 Electroacoustics - Simulators of human head and ear - Part 4: Occluded-ear simulator for the measurement of earphones coupled to the ear by means of ear inserts
IEC 60118-7:2005 Electroacoustics - Hearing aids - Part 7: Measurement of the performance characteristics of hearing aids for production, supply and delivery quality assurance purposes
IEC 60118-13:2016 Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC)
IEC 60645-1:2017 Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone and speech audiometry
IEC 60711:1981 Occluded-ear simulator for the measurement of earphones coupled to the ear by ear inserts
IEC 62368-1:2014 Audio/video, information and communication technology equipment - Part 1: Safety requirements

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