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EN 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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems

Superseded date

09-04-2020

Superseded by

EN IEC 60601-2-66:2020

Published date

27-11-2015

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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
       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
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
Annex ZA (normative) - Normative references to
         international publications with their
         corresponding European publications
Annex ZZ (informative) - Coverage of Essential Requirements
         of EU Directives

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
CLC/SR 29
DocumentType
Standard
PublisherName
European Committee for Standards - Electrical
Status
Superseded
SupersededBy

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
EN 60118-0:2015 Electroacoustics - Hearing aids - Part 0: Measurement of the performance characteristics of hearing aids
EN 60118-13:2011 Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC)
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
EN 60950-1:2006/A2:2013 INFORMATION TECHNOLOGY EQUIPMENT - SAFETY - PART 1: GENERAL REQUIREMENTS (IEC 60950-1:2005/A2:2013, MODIFIED)
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
EN 62304:2006/A1:2015 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015)
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
EN 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
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
EN 60601-1-11:2015 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

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