EN IEC 60601-2-66:2020
(Main)Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
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
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 International Standard IEC 60601-2-66:2019 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 60601-1-9 NOTE Harmonized as EN 60601-1-9
IEC 60601-1-10 NOTE Harmonized as EN 60601-1-10
IEC 60645-1:2017 NOTE Harmonized as EN 60645-1:2017 (not modified)
IEC 61000-4-2 NOTE Harmonized as EN 61000-4-2
IEC 61000-4-8 NOTE Harmonized as EN 61000-4-8
IEC 62489-1:2010 NOTE Harmonized as EN 62489-1:2010 (not modified)
IEC 62489-1:2010/A1:2014 NOTE Harmonized as EN 62489-1:2010/A1:2015 (not modified)
IEC 62489-1:2010/A2:2017 NOTE Harmonized as EN 62489-1:2010/A2:2018 (not modified)
IEC 62366-1:2015 NOTE Harmonized as EN 62366-1:2015 (not modified)
CISPR 11 NOTE Harmonized as EN 55011
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu.
Clause 2 of the general standard applies except as follows:
Replacement:
Publication Year Title EN/HD Year
IEC 60950-1 (mod) 2005 Information technology equipment - Safety EN 60950-1 2006
- Part 1: General requirements
- - + A11 2009
+ A1 (mod) 2009 + A1 2010
- - + A12 2011
+ A2 (mod) 2013 + A2 2013
IEC 62368-1 (mod) 2014 Audio/video, information and EN 62368-1 2014
communication technology equipment -
Part 1: Safety requirements
- - + A11 2017
Addition:
Publication Year Title EN/HD Year
IEC 60118-0 2015 Electroacoustics - Hearing aids - Part 0: EN 60118-0 2015
Measurement of the performance
characteristics of hearing aids
IEC 60118-13 - Electroacoustics - Hearing aids - Part 13: EN 60118-13 2019
Electromagnetic compatibility (EMC)
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
+ A1 2012 + A1 2013
- - + A12 2014
Publication Year Title EN/HD Year
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
IEC 60601-1-11 2015 Medical electrical equipment - Part 1-11: EN 60601-1-11 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Requirements for medical
electrical equipment and medical electrical
systems used in the home healthcare
environment
IEC 62304 - Medical device software - Software life EN 62304 2006
cycle processes
+ A1 2015
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives
This European standard has been prepared under a Commission’s standardisation request M/023 and
M432 concerning the development of European Standards related to medical devices given to
CENELEC by the European Commission and the European Free Trade Association to provide a
means of conforming to the Essential Requirements given in Annex I of the EU Directives 93/42/EEC
as amended by 2007/47/EC.
General Guidance:
Once this standard will be cited in the Official Journal of the European Union under that Directive,
compliance with the clauses of this standard given in Table ZZ.1 confers, within the limits of the scope
of this standard, a presumption of conformity with the corresponding Essential Requirements (ERs) of
that Directive and associated EFTA regulations.
NOTE 1 This standard is intended to be applied in its entirety only. Selected clauses or
subclauses may be not applicable due to the specific type of equipment under consideration. It is
necessary to understand and apply Clauses 1 to 5. It is also recommended to understand and apply
those clauses which contain general requirements related to a specific subclause. Elements of the
standard that are not cited in Table ZZ.1 may be relevant for the appropriate fulfilment of certain
essential requirements through indirect reference, and for safety and performance aspects of the
device, that are not addressed through essential requirements.
NOTE 2 Where a reference from a clause of this standard to the risk management process is
made, the risk management process needs to be in compliance to the MDD (Directive 93/42/EEC
amended by 2007/47/EC). This means that risks have to be reduced "as far as possible", "to a
minimum", "to the lowest possible level", "minimized" or "removed", according to the wording of the
corresponding essential requirement.
NOTE 3 With respect to Note 4 of 4.2.2 General requirement for risk management, the
manufacturer’s policy for determining acceptable risk must be in compliance with essential
requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the directive.
NOTE 4 References in the Clauses 3 to 17 or in the Annexes of this standard specify whether
the normative references listed in Clause 2 as cited in Annex ZA are to be applied in whole or in part.
NOTE 5 This Annex ZZ is based on Normative References according to Annex ZA, replacing
the references in the core text.
NOTE 6 According to the scope of this standard the coverage in Table ZZ.1 only applies to the
design and construction of HEARING AIDS and HEARING AID SYSTEMS. This European Standard
lists in Table ZZ.1 only the essential requirements covered.
WARNING: Other requirements and other EU Directives and Regulations may be applicable to the
product(s) falling within the scope of this standard.
Table ZZ.1 – Relationship between Essential Requirements of Directive 93/42/EEC
amended by 2007/47/EC, and clauses and subclauses of this standard
Remarks/Notes
Essential Requirements of Clause(s)/sub-
Directive 93/42/EEC clause(s) of this EN
201.7.9.1
1, second indent This document (201.7.9.1, 201.7.9.2.1,
201.7.9.2.1
201.7.9.2.2) covers requirements related to
201.7.9.2.2
instructions for use, including safety
warnings and notices by considering the
technical knowledge, experience, education
and training and where applicable the
medical and physical conditions of intended
users (design for lay, professional, disabled
or other users).
201.7.2.17
5 Covered by requirements to design and
201.7.9.2.2
packaging (201.7.2.17) to withstand
201.15.3
transport and storage with regards of
201.15.3.7
mechanical strength (201.15.3), resistance
to environmental conditions (201.15.3.7) and
the necessary instructions (201.7.9.2.2).
201.7.9.2.1
6 The reduction of unintentional exposure to
201.9.6
excessive acoustic noise is covered in
201.9.6 regarding the design.
201.7.9.2.1 covers information and
instructions for the user related to side
effects.
201.11.1.1
7.1, first indent Covered for risks of fire and high
201.13.1.2
temperatures.
201.11.6.6
7.3 This document covers (201.15.3.7,
201.15.3.7
201.11.6.6) the design of devices in such a
way that they can be used safely with the
materials, substances and gases with which
they enter into contact during their normal
use or during routine procedures.
Requirements for HEARING AIDS that are
intended to be used in explosive and
oxygenenriched atmospheres are not
contained in this standard (see 201.11.2).
7.5, first sentence of first 201.7.9.2.4 Covered for the risk of leakage from the
paragraph only battery in situ.
7.6 201.11.6.5 Covered in 201.11.6.5.
8.1, first sentence only 201.7.9.2.12 Design covered in 201.12.2, 201.11.6.6 and
instruction covered in 201.7.9.2.12.
201.11.6.6
201.12.2
9.1 201.5.5 c)
201.6.2
201.7.9.2.5
201.7.9.2.9
201.8.1
201.8.2.1
201.8.4.2
Remarks/Notes
Essential Requirements of Clause(s)/sub-
Directive 93/42/EEC clause(s) of this EN
9.2, first indent 201.9 Mechanical risks (e.g. ‘entanglement’) are
covered by 201.9.
9.2, second indent 201.5.3 Covered in respect of environmental
temperatures, humidity or variations in
201.5.7
pressure: 201.5.3, 201.5.7, 201.7.2.17,
201.7.2.17
201.7.9.2.1, 201.7.9.2.2, 201.15.3.7 of this
201.7.9.2.1
document provide design and test
201.7.9.2.2 requirements with regards to climatic
environmental conditions which are suitable
201.15.3.7
to remove or minimize as far as possible
these risks.
9.2, third indent 201.7.9.2.2 To fully cover this ER, risks must be
removed or minimised as far as possible.
201.17
Covered for the serviceability of hearing aids
9.2, fourth indent 201.15.2
subject to mechanical wear, electrical
degradation or ageing.
9.3 201.11.1.1 Risks of fire and high temperatures covered
in 201.11.1.1, 201.13.1.2.
201.13.1.2
HEARING AIDS are normally not exposed to
flammable substances or to substances
which could cause combustion.
The requirements for HEARING AIDS
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.