IEC 60601-2-66 Ed. 3.0 b:2019

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

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

PUBLISH DATE 2019
PAGES 118

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

IEC 60601-2-66:2019 is available as IEC 60601-2-66:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.

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:

  • Revision of the definition about ESSENTIAL PERFORMANCE;
  • Revision of the application of IEC 60601-1-2:2014 for electromagnetic disturbances;
  • Correction of the used voltage for HEARING AIDS from 1,6 V to 4,5 V;
  • Correction of the drop test level from 1,5 m to 1,0 m;
  • Correction of the wording of IEC 60601-2-66:2015.
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