EN 60601-2-66:2015

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.

Medizinische elektrische Geräte - Teil 2-66: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Hörgeräten und Hörgerätesystemen

Appareils électromédicaux - Partie 2-66: Exigences particulières pour la sécurité de base et les performances essentielles des instruments d'audition et systèmes d'audition

L'IEC 60601-2-66:2015 s'applique à la sécurité de base des instruments d'audition et des systèmes d'audition, également désignés ci-après par appareil EM ou système EM. Cette deuxième édition annule et remplace la première édition parue en 2012. Cette édition constitue une révision technique visant à adapter l'IEC 60601-2-66:2012 aux corrections techniques introduites par l'Amendement 1 (2012) à l'IEC 60601-1:2005, ainsi qu'à clarifier et à corriger la formulation de cette norme particulière, et à mettre en oeuvre les modifications mineures demandées par les parties intéressées.

Medicinska električna oprema - 2-66. del: Posebne zahteve za osnovno varnost in bistvene lastnosti slušnih pripomočkov in sistemov slušnih instrumentov

Standard se uporablja za OSNOVNO VARNOST SLUŠNIH PRIPOMOČKOV in SISTEMOV SLUŠNIH INSTRUMENTOV (v nadaljevanju tudi: ELEKTROMEDICINSKA OPREMA ali ELEKTROMEDICINSKI SISTEM). Če je poglavje ali podpoglavje namenjeno samo obravnavi SLUŠNIH PRIPOMOČKOV ali SISTEMOV SLUŠNIH INSTRUMENTOV, bo to navedeno v naslovu in besedilu poglavja ali podpoglavja. Če ni navedeno, poglavje ali podpoglavje obravnava SLUŠNE PRIPOMOČKE in SISTEME SLUŠNIH INSTRUMENTOV, kot je primerno. Temeljnih TVEGANJ pri nameravani fiziološki funkciji SLUŠNIH PRIPOMOČKOV ali SISTEMOV SLUŠNIH INSTRUMENTOV, ki spadajo na področje uporabe tega standarda, posebne zahteve tega standarda ne vključujejo, razen v točkah 201.7.9.2 in 201.9.6. PRIKLJUČKI k SLUŠNIM PRIPOMOČKOM, ki se uporabljajo v OKOLJU DOMAČE ZDRAVSTVENE OSKRBE (npr. enote za daljinsko vodenje, avdio pretočniki, polnilniki baterij, električno napajanje), so zajeti v najprimernejšem standardu, standardu IEC 60065, IEC 60950-1 ali drugih primernih varnostnih standardih IEC. Uporabi se lahko tudi splošni standard. SLUŠNI PRIPOMOČKI nimajo OMREŽNEGA DELA za povezavo z izmeničnim NAPAJALNIM OMREŽJEM. Povezava z NAPAJALNIM OMREŽJEM sistema SLUŠNIH INSTRUMENTOV se izvede prek električnega napajanja, polnilca ali drugih PRIKLJUČKOV. PRIKLJUČKI, povezani s SLUŠNIM PRIPOMOČKOM, lahko sestavljajo SISTEM SLUŠNIH INSTRUMENTOV. Vse točke tega standarda veljajo le za SLUŠNI PRIPOMOČEK s snemljivimi deli. Za ostale sestavne dele SISTEMA SLUŠNIH INSTRUMENTOV veljajo zahteve tega standarda, ki zadevajo povezavo s SISTEMOM SLUŠNIH INSTRUMENTOV. Programske vmesnike ali PRIKLJUČKE za klinično uporabo zajema splošni standard.

General Information

• Status: Withdrawn
• Publication Date: 26-Nov-2015
• Withdrawal Date: 30-Jul-2018
• ICS: 11.180.15 - Aids for deaf and hearing impaired people
• ICS: 17.140.50 - Electroacoustics
• Technical Committee: CLC/SR 29 - Electroacoustics
• Drafting Committee: IEC/TC 29 - IEC_TC_29
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 19-Feb-2023
• Completion Date: 19-Feb-2023
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 60601-2-66:2016 - Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems

Relations

• Replaces: EN 60601-2-66:2013 - Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems
• Effective Date: 01-Dec-2015
• Replaced By: EN IEC 60601-2-66:2020 - Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems
• Effective Date: 07-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-66:2016
01-marec-2016
1DGRPHãþD
SIST EN 60601-2-66:2013
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLVOXãQLKSULSRPRþNRYLQVLVWHPRYVOXãQLKLQVWUXPHQWRY
Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and
essential performance of hearing instruments and hearing instrument systems
Ta slovenski standard je istoveten z: EN 60601-2-66:2015
ICS:
11.180.15 3ULSRPRþNL]DJOXKHRVHEHLQ Aids for deaf and hearing
RVHEH]RNYDURVOXKD impaired people
SIST EN 60601-2-66:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-66:2016

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SIST EN 60601-2-66:2016


EUROPEAN STANDARD EN 60601-2-66

NORME EUROPÉENNE

EUROPÄISCHE NORM
November 2015
ICS 11.180.15; 17.140.50 Supersedes EN 60601-2-66:2013
English Version
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)
Appareils électromédicaux - Partie 2-66: Exigences Medizinische elektrische Geräte - Teil 2-66: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des instruments d'audition et systèmes wesentlichen Leistungsmerkmale von Hörgeräten und
d'audition Hörgerätesystemen
(IEC 60601-2-66:2015) (IEC 60601-2-66:2015)
This European Standard was approved by CENELEC on 2015-07-31. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.


European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 60601-2-66:2015 E

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SIST EN 60601-2-66:2016
EN 60601-2-66:2015
European foreword
The text of document 29/851/FDIS, future edition 2 of IEC 60601-2-66, prepared by
IEC/TC 29 "Electroacoustics" was submitted to the IEC-CENELEC parallel vote and approved by
CENELEC as EN 60601-2-66:2015.

The following dates are fixed:
• latest date by which the document has to be (dop) 2016-05-27
implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2018-07-31
• latest date by which the national
standards conflicting with the
document have to be withdrawn

This document supersedes EN 60601-2-66:2013.

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.

This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).

For the relationship with EU Directive(s) see informative Annex ZZ, which is an integral part of this
document.
Endorsement notice
The text of the International Standard IEC 60601-2-66:2015 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:

IEC 60118-4:2014 NOTE Harmonized as EN 60118-4:2015 (not modified).
IEC 60318-5:2006 NOTE Harmonized as EN 60318-5:2006 (not modified).
IEC 60601-1-4:1996 NOTE Harmonized as EN 60601-1-4:1996 (not modified).
IEC 60601-1-9 NOTE Harmonized as EN 60601-1-9.
IEC 60601-1-10 NOTE Harmonized as EN 60601-1-10.
...