BS 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems
Hardcopy , PDF
06-04-2020
English
31-12-2015
Important note : All end users must be registered with an Account prior to user licenses being assigned.| Committee |
EPL/29
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| DevelopmentNote |
Supersedes 10/30240267 DC. (02/2013) Supersedes 14/30315340 DC. (01/2016)
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| DocumentType |
Standard
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| Pages |
64
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| PublisherName |
British Standards Institution
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| Status |
Superseded
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| SupersededBy | |
| Supersedes |
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.
| Standards | Relationship |
| IEC 60601-2-66:2015 | Identical |
| EN 60601-2-66:2015 | Identical |
| EN 60191-6:2009 | 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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