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SSH EN 60601-2-66:2015

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

Sep 27, 2016

General information

60.60     Jul 29, 2016

DPS

DPS/KT 6

European Norm

11.180.15     17.140.50  

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Scope

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.

Related directives

Directives related to this standards.

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN 60601-2-66:2013

NOW

PUBLISHED
SSH EN 60601-2-66:2015
60.60 Standard published
Jul 29, 2016

Related project

Adopted from EN 60601-2-66:2015

Adopted from IEC 60601-2-66 Ed. 2.0 b