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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.180 Aids for disabled or handicapped persons>11.180.15 Aids for deaf and hearing impaired people>BS EN IEC 60601-2-66:2020 Medical electrical equipment Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems
immediate downloadReleased: 2020-04-06
BS EN IEC 60601-2-66:2020 Medical electrical equipment Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems

BS EN IEC 60601-2-66:2020

Medical electrical equipment Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems

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Standard number:BS EN IEC 60601-2-66:2020
Pages:68
Released:2020-04-06
ISBN:978 0 580 97038 2
Status:Standard
DESCRIPTION

BS EN IEC 60601-2-66:2020


This standard BS EN IEC 60601-2-66:2020 Medical electrical equipment is classified in these ICS categories:
  • 17.140.50 Electroacoustics
  • 11.180.15 Aids for deaf and hearing impaired people
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:
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.