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

Publication date:   Apr 18, 2016

General information

99.60 Withdrawal effective   Feb 19, 2023

CENELEC

CLC/SR 29 Electroacoustics

European Norm

11.180.15   Aids for deaf and hearing impaired people | 17.140.50   Electroacoustics

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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 legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
EN 60601-2-66:2013

NOW

WITHDRAWN
EN 60601-2-66:2015
99.60 Withdrawal effective
Feb 19, 2023

REVISED BY

PUBLISHED
EN IEC 60601-2-66:2020