IEC 60601-2-66:2019
Collections
International IEC standards
Publication date
October 2019
Number of pages
115 p.
Reference
IEC 60601-2-66:2019
IEC 60601-2-66:2019
October 2019
International standard
Current
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 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.
Main informations
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Sumary
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 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.
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.
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Replaced standards
(1)
IEC 60601-2-66:2015
June 2015
International standard
Cancelled
Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems
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.
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