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IEC 60601-2-66:2012

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by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

Available format(s)

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

Superseded date

31-12-2021

Superseded by

IEC 60601-2-66:2015

Language(s)

English - French, Spanish, Castilian

Published date

02-10-2012

€280.71
Excluding VAT

IEC 60601-2-66:2012 International Standard applies to the basic safety of hearing instruments and hearing instrument systems. Hazards inherent in the intended physiological function of hearing instruments or hearing instrument systems within the scope of this standard are not covered by specific requirements in this standard except in 201.7.9.2 and 201.9.6. Accessories to hearing instruments in the home healthcare environment (e.g. remote control units, audio streamers, battery chargers, power supplies) are covered by the most applicable standard, IEC 60065, IEC 60950-1 or other applicable IEC safety standards. Accessories connected to a hearing instrument may form a hearing instrument system. Only the hearing instrument and its detachable parts are subject to all applicable clauses of this particular standard. The remaining components of the hearing instrument system are subject to requirements of this particular standard that result from their connection to the hearing instrument system. This standard does not apply to:
- cochlear implants or other implanted hearing instruments;
- bone conduction hearing instruments;
- educational hearing instruments (i.e. group hearing instruments, auditory trainers etc.);
- the application of a hearing instrument for the measurement of hearing levels. IEC 60645-1 applies;
- audio-frequency induction-loop systems or their component parts, as described in IEC 60118-4 and IEC 62489-1;
- assisted hearing instrument systems using infra-red or radio;
- and the sound generating function of a tinnitus masker.

DocumentType
Standard
Pages
86
PublisherName
International Electrotechnical Committee
Status
Superseded
SupersededBy

Standards Relationship
UNE-EN 60601-2-66:2013 Identical
BS EN 60601-2-66:2013 Identical

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