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

Status : Current   Published : April 2020

Format
PDF

Format
HARDCOPY



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.




Standard NumberBS EN IEC 60601-2-66:2020
TitleMedical electrical equipment. Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems
StatusCurrent
Publication Date06 April 2020
Normative References(Required to achieve compliance to this standard)IEC 62368-1:2018, EN 60950-1:2006, IEC 60950-1:2005/AMD2:2013, EN 60118-0:2015, EN 62368-1:2014/A11:2017, IEC 60601-1-11:2015, IEC 60118-0:2015, EN 60950-1:2006/A2:2013, IEC 60601-1-2:2014, IEC 60950-1:2005, IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60950-1:2005/AMD1:2009, EN 60950-1:2006/A11:2009, EN 62368-1:2014, IEC 62304, EN 60118-13:2019, IEC 60118-13
Informative References(Provided for Information)EN 60601-1:2006, IEC 62489-1:2010/AMD1:2014, EN 60318-5:2006, IEC 62489-1:2010, EN 62366-1:2015, EN 60601-1-11:2015, ISO/TR 25417:2007, IEC 60601-1:2005, IEC 60645-1:2017, EN 62489-1:2010/A1:2015, EN 62489-1:2010/A2:2018, IEC 60318-5:2006, EN 60118-4:2015, IEC 62489-1:2010/AMD2:2017, EN 60601-1:2006/A12:2014, IEC 60601-1-2:2014, ISO/FDIS 80000-8:2019, EN 61000-4-2, IEC 61000-4-8, ANSI C63.19, CISPR 11, EN 55011, EN 60601-1-9, EN 60601-1-10, IEC 61000-4-2, IEC 60601-1-9, EN 61000-4-8, IEC 60601-1-10, IEC 60601-1-4, FDA guidance 21 CFR 801.420, EN 62489-1:2010, IEC 60601-1-11:2015, EN 60601-1:2006/A1:2013, IEC 60118-4:2014, IEC 60118-0:2015, EN 60645-1:2017, IEC 62366-1:2015, EN 60118-0:2015
ReplacesBS EN 60601-2-66:2015
International RelationshipsEN IEC 60601-2-66:2020,IEC 60601-2-66:2019
Draft Superseded By18/30354316 DC
DescriptorsMedical equipment, Acoustic measurement, Performance, Acoustoelectric devices, Safety engineering, Hearing aids, Electronic equipment and components, Electrical safety, Acoustic equipment, Electrical medical equipment, Electrical equipment, Safety measures
ICS11.180.15
17.140.50
Title in FrenchAppareils électromédicaux Exigences particulières pour la sécurité de base et les performances essentielles des appareils de correction auditive et des systèmes de correction auditive
Title in GermanMedizinische elektrische Geräte Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Hörgeräten und Hörgerätesystemen
CommitteeEPL/29
ISBN978 0 580 97038 2
PublisherBSI
FormatA4
DeliveryYes
Pages68
File Size1.361 MB
Price£254.00


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