SRPS EN 60601-2-66:2017

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

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

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.