I.S. EN 60601-2-66:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
02-05-2020
English
01-01-2015
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National Foreword
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
Pertains to the BASIC SAFETY of HEARING INSTRUMENTS and HEARING INSTRUMENT SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM.
| DevelopmentNote |
For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
|
| DocumentType |
Standard
|
| Pages |
118
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| EN 60601-2-66:2015 | Identical |
| 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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