CSA C22.2 No. 60601-2-66 : 2015

Superseded

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Superseded date

11-16-2019

Language(s)

English

Published date

01-01-2015

Publisher

Canadian Standards Association

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

Pertains to the BASIC SAFETY of HEARING INSTRUMENTS and HEARING INSTRUMENT SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM.

DocumentType	Standard
Pages	114
PublisherName	Canadian Standards Association
Status	Superseded
SupersededBy	CSA C22.2 No. 60601-2-66 : 2015(R2019)

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
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
C22.1-15	Canadian Electrical Code, Part I (23rd Edition), Safety Standard for Electrical Installations
ISO/TR 25417:2007	Acoustics Definitions of basic quantities and terms
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 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 60601-1-4:1996+AMD1:1999 CSV	Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems