BS EN 60601-2-66:2013 - Medical electrical equipment. Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems

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BS EN 60601-2-66:2013

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

Status : Revised, Superseded, Withdrawn   Published : February 2013 Replaced By : BS EN 60601-2-66:2015

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IEC 60601-2-66:2012 International Standard applies to the basic safety of hearing instruments and hearing instrument systems. Hazards inherent in the intended physiological function of hearing instruments or hearing instrument systems within the scope of this standard are not covered by specific requirements in this standard except in 201.7.9.2 and 201.9.6. Accessories to hearing instruments in the home healthcare environment (e.g. remote control units, audio streamers, battery chargers, power supplies) are covered by the most applicable standard, IEC 60065, IEC 60950-1 or other applicable IEC safety standards. Accessories connected to a hearing instrument may form a hearing instrument system. Only the hearing instrument and its detachable parts are subject to all applicable clauses of this particular standard. The remaining components of the hearing instrument system are subject to requirements of this particular standard that result from their connection to the hearing instrument system. This standard does not apply to:


- cochlear implants or other implanted hearing instruments;


- bone conduction hearing instruments;


- educational hearing instruments (i.e. group hearing instruments, auditory trainers etc.);


- the application of a hearing instrument for the measurement of hearing levels. IEC 60645-1 applies;


- audio-frequency induction-loop systems or their component parts, as described in IEC 60118-4 and IEC 62489-1;


- assisted hearing instrument systems using infra-red or radio;


- and the sound generating function of a tinnitus masker.




Standard NumberBS EN 60601-2-66:2013
TitleMedical electrical equipment. Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems
StatusRevised, Superseded, Withdrawn
Publication Date28 February 2013
Withdrawn Date31 December 2015
Cross ReferencesIEC 60950-1:2005, IEC 60065:2001, IEC 60118-7:2005, IEC 60118-13, IEC 60601-1-11:2010, IEC 62304, IEC 62366:2007, IEC 60118-4:2006, IEC 60318-5:2006, IEC 60601-1-4:1996, IEC 60645-1:2001, IEC 61672-1:2002, IEC 62489-1:2010, ISO/TR 25417:2007, ISO 80000-8:2007, EN 60950-1:2006, EN 60950-1:2006+AC:2011, EN 60950-1:2006+A11:2009, EN 60950-1:2006+A12:2011, EN 60065:2002, EN 60065:2002+ corr. August:2007, EN 60065:2002+A11:2008, EN 60065:2002+A12:2011, EN 60118-13, EN 60601-1-11:2010, EN 62304, EN 62366:2008
Replaced ByBS EN 60601-2-66:2015
International RelationshipsIEC 60601-2-66:2012,EN 60601-2-66:2013
Draft Superseded By10/30240267 DC
DescriptorsAcoustic equipment, Electrical equipment, Electronic equipment and components, Acoustic measurement, Hearing aids, Acoustoelectric devices, Safety engineering, Electrical safety, Performance, Safety measures, Electrical medical equipment, Medical equipment
ICS11.180.15
17.140.50
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 74148 7
PublisherBSI
FormatA4
DeliveryNo
Pages48
File Size687 KB
Price£232.00


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