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IEC 60601-2-66:2015

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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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 , PDF 3 Users , PDF 5 Users , PDF 9 Users

Superseded date

31-12-2021

Language(s)

English - French, Spanish, Castilian

Published date

26-06-2015

€280.71
Excluding VAT

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

IEC 60601-2-66:2015 applies to the basic safety of hearing instruments and hearing instrument systems, hereafter also referred to as ME equipment or ME system. This second edition cancels and replaces the first edition published in 2012. It constitutes a technical revision to adapt IEC 60601-2-66:2012 to the technical corrections introduced by Amendment 1 (2012) to IEC 60601-1:2005, as well as to clarify and correct the wording of this particular standard and to implement minor changes requested by interested parties.

Committee
TC 29
DevelopmentNote
Stability Date: 2017. (07/2015)
DocumentType
Standard
Pages
88
PublisherName
International Electrotechnical Committee
Status
Superseded
SupersededBy
Supersedes

ANSI/AAMI CI86:2017 COCHLEAR IMPLANT SYSTEMS: REQUIREMENTS FOR SAFETY, FUNCTIONAL VERIFICATION, LABELING AND RELIABILITY REPORTING
PD IEC/TR 60601-4-1:2017 Medical electrical equipment Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy
IEC 60118-13:2016 Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC)
IEC TR 60601-4-1:2017 Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
PD IEC/TR 62809:2013 Summary of requirements and tests for products in the scope of IEC 60601-2-66
IEC TR 62809:2013 Summary of requirements and tests to products in the scope of IEC 60601-2-66

IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV Information technology equipment - Safety - Part 1: General requirements
IEC 62489-1:2010+AMD1:2014 CSV Electroacoustics - Audio-frequency induction loop systems for assisted hearing - Part 1: Methods of measuring and specifying theperformance of system components
ISO/TR 25417:2007 Acoustics Definitions of basic quantities and terms
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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 60601-1-10:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
ISO 80000-8:2007 Quantities and units Part 8: Acoustics
IEC 60318-5:2006 Electroacoustics - Simulators of human head and ear - Part 5: 2 cm<sup>3</sup> coupler for the measurement of hearing aids and earphones coupled to the ear by means of ear inserts
IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
IEC 60118-4:2014+AMD1:2017 CSV Electroacoustics - Hearing aids - Part 4: Induction-loop systems for hearing aid purposes - System performance requirements
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
IEC 60118-0:2015 Electroacoustics - Hearing aids - Part 0: Measurement of the performance characteristics of hearing aids
IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems

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