SRPS EN IEC 60601-2-66:2020

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

Scope

<!-- NEW! -->IEC 60601-2-66:2019 is available as <a href="https://webstore.iec.ch/publication/65931">IEC 60601-2-66:2019 RLV</a> which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.</br></br>IEC 60601-2-66:2019 applies to the BASIC SAFETY of HEARING AIDS and HEARING AID SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. IEC 60601-2-66:2019 cancels and replaces the second edition published in 2015. It constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:

a) revision of the definition about ESSENTIAL PERFORMANCE;

b) revision of the application of IEC 60601-1-2:2014 for electromagnetic disturbances;

c) correction of the used voltage for HEARING AIDS from 1,6 V to 4,5 V;

d) correction of the drop test level from 1,5 m to 1,0 m;

e) correction of the wording of IEC 60601-2-66:2015.

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.