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IEC 60601-2-66-ed.3.0
Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems
Translate name
STANDARD published on 16.10.2019
The information about the standard:
Designation standards: IEC 60601-2-66-ed.3.0
Publication date standards: 16.10.2019
SKU: NS-974455
The number of pages: 115
Approximate weight : 376 g (0.83 lbs)
Country: International technical standard
Category: Technical standards IEC
The category - similar standards:
Annotation of standard text IEC 60601-2-66-ed.3.0 :
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. LIEC 60601-2-66:2019 sapplique a la SECURITE DE BASE des APPAREILS DE CORRECTION AUDITIVE et des SYSTEMES DE CORRECTION AUDITIVE, egalement appeles ci-apres "APPAREILS EM" ou "SYSTEMES EM". LIEC 60601-2-66:2019 annule et remplace la deuxieme edition parue en 2015. Cette edition constitue une revision technique. Cette edition inclut les modifications techniques majeures suivantes par rapport a ledition precedente: a) revision de la definition des PERFORMANCES ESSENTIELLES; b) revision de lapplication de lIEC 60601-1-2:2014 pour les perturbations electromagnetiques; c) correction de la tension utilisee pour les APPAREILS DE CORRECTION AUDITIVE de 1,6 V a 4,5 V; d) correction du niveau dessai de chute de 1,5 m a 1,0 m; e) correction de la formulation de lIEC 60601-2-66:2015.
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