BS EN 60601-2-66:2015 - Medical electrical equipment. Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems

BS EN 60601-2-66:2015

Medical electrical equipment. Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems

Status : Superseded, Withdrawn   Published : December 2015 Replaced By : BS EN IEC 60601-2-66:2020

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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.




Standard NumberBS EN 60601-2-66:2015
TitleMedical electrical equipment. Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems
StatusSuperseded, Withdrawn
Publication Date31 December 2015
Withdrawn Date06 April 2020
Normative References(Required to achieve compliance to this standard)IEC 60118-13, IEC 62366:2007, EN 62366:2008, EN 60950-1:2006+A1:2010, EN 60601-1:2006+A12:2014, EN 60601-1:2006, EN 60601-1:2006+A1/AC:2014, IEC 60601-1:2015+A1:2012, IEC 60601-1-11:2015, EN 60950-1:2006, IEC 60950-1:2005, IEC 60118-0:2015, EN 60950-1:2006+A2:2013, EN 60950-1:2006+AC:2011, IEC 60601-1:2015, EN 60950-1:2006+A11:2009, EN 60601-1-11:2015, IEC 60950-1:2005+A2:2013, EN 60601-1:2006+A1:2013, EN 60950-1:2006+A12:2011, IEC 60950-1:2005+A1:2009, EN 60118-0:2015, IEC 62304, EN 60118-13, EN 62304
Informative References(Provided for Information)No other standards are informatively referenced
Replaced ByBS EN IEC 60601-2-66:2020
ReplacesBS EN 60601-2-66:2013
International RelationshipsIEC 60601-2-66:2015,EN 60601-2-66:2015,EN 60191-6:2009
Draft Superseded By14/30315340 DC
DescriptorsSafety measures, Electronic equipment and components, Hearing aids, Electrical medical equipment, Electrical equipment, Acoustoelectric devices, Performance, Safety engineering, Electrical safety, Medical equipment, Acoustic equipment, Acoustic measurement
ICS17.140.50
11.180.15
Title in FrenchAppareils électromédicaux. Exigences particulières pour la sécurité de base et les performances essentielles des instruments d'audition et systèmes d'audition
Title in GermanMedizinische elektrische Geräte. Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Hörgeräten und Hörgerätesystemen
CommitteeEPL/29
ISBN978 0 580 88483 2
PublisherBSI
FormatA4
DeliveryYes
Pages64
File Size1.932 MB
Price£254.00


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