Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems

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.

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 appareils de correction auditive et des systèmes de correction auditive

IEC 60601-2-66:2019 est disponible sous forme de IEC 60601-2-66:2019 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.L'IEC 60601-2-66:2019 s'applique à la SECURITE DE BASE des APPAREILS DE CORRECTION AUDITIVE et des SYSTEMES DE CORRECTION AUDITIVE, également appelés ci-après "APPAREILS EM" ou "SYSTEMES EM". L'IEC 60601-2-66:2019 annule et remplace la deuxième édition parue en 2015. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: a) révision de la définition des PERFORMANCES ESSENTIELLES; b) révision de l'application de l'IEC 60601-1-2:2014 pour les perturbations électromagnétiques; c) correction de la tension utilisée pour les APPAREILS DE CORRECTION AUDITIVE de 1,6 V à 4,5 V; d) correction du niveau d'essai de chute de 1,5 m à 1,0 m; e) correction de la formulation de l'IEC 60601-2-66:2015.

Medicinska električna oprema - 2-66. del: Posebne zahteve za osnovno varnost in bistvene lastnosti slušnih pripomočkov in sistemov (IEC 60601-2-66:2019)

General Information

Status
Published
Publication Date
02-Apr-2020
Withdrawal Date
18-Feb-2023
Technical Committee
Drafting Committee
Current Stage
6060 - Document made available - Publishing
Start Date
03-Apr-2020
Completion Date
03-Apr-2020

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN IEC 60601-2-66:2020
01-julij-2020
Nadomešča:
SIST EN 60601-2-66:2016
Medicinska električna oprema - 2-66. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti slušnih pripomočkov in sistemov (IEC 60601-2-66:2019)
Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and
essential performance of hearing aids and hearing aid systems (IEC 60601-2-66:2019)
Medizinische elektrische Geräte - Teil 2-66: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Hörgeräten und
Hörgerätesystemen (IEC 60601-2-66:2019)
Appareils électromédicaux - Partie 2-66: Exigences particulières pour la sécurité de base
et les performances essentielles des instruments d'audition et systèmes d'audition (IEC
60601-2-66:2019)
Ta slovenski standard je istoveten z: EN IEC 60601-2-66:2020
ICS:
11.180.15 Pripomočki za gluhe osebe in Aids for deaf and hearing
osebe z okvaro sluha impaired people
SIST EN IEC 60601-2-66:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 60601-2-66:2020

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SIST EN IEC 60601-2-66:2020


EUROPEAN STANDARD EN IEC 60601-2-66

NORME EUROPÉENNE

EUROPÄISCHE NORM
April 2020
ICS 11.180.15; 17.140.50 Supersedes EN 60601-2-66:2015 and all of its
amendments and corrigenda (if any)
English Version
Medical electrical equipment - Part 2-66: Particular requirements
for the basic safety and essential performance of hearing aids
and hearing aid systems
(IEC 60601-2-66:2019)
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 appareils de correction auditive et des wesentlichen Leistungsmerkmale von Hörgeräten und
systèmes de correction auditive Hörgerätesystemen
(IEC 60601-2-66:2019) (IEC 60601-2-66:2019)
This European Standard was approved by CENELEC on 2020-02-19. 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2020 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN IEC 60601-2-66:2020 E

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SIST EN IEC 60601-2-66:2020
EN IEC 60601-2-66:2020 (E)
European foreword
The text of document 29/1023/FDIS, future edition 3 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 IEC 60601-2-66:2020.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2020-11-19
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2023-02-19
document have to be withdrawn
This document supersedes EN 60601-2-66:2015 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC 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 Internat
...

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