EN 60601-2-66:2015

SLOVENSKI STANDARD
01-marec-2016
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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.
IEC 60645-1:2012 NOTE Harmonized as EN 60645-1:2015 (not modified).
IEC 62489-1:2010 NOTE Harmonized as EN 62489-1:2010 (not modified).
ISO 80000-8:2007 NOTE Harmonized as EN ISO 80000-8:2007 (not modified).

Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When 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.

Annex ZA of EN 60601-1:2006 applies except as follows:

Publication Year Title EN/HD Year
Replacement:
IEC 60950-1 2005 Information technology equipment - EN 60950-1 2006
(mod) Safety - Part 1: General requirements +AC 2011
+A11 2009
+A1 (mod) 2009 +A1 2010
+A12 2011
+A2 (mod) 2013 +A2 2013
Addition:
IEC 60118-0 2015 Electroacoustics - Hearing aids - EN 60118-0 2015
Part 0: Measurement of the performance
characteristics of hearing aids
IEC 60118-13 -  Electroacoustics - Hearing aids - EN 60118-13 -
Part 13: Electromagnetic compatibility
(EMC)
IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic + corr. March 2010
safety and essential performance
+A1 2012 +A1 2013
+A1/AC 2014
+A12 2014
Publication Year Title EN/HD Year
IEC 60601-1-11 2015 Medical electrical equipment - EN 60601-1-11 2015
Part 1-11: 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 -
cycle processes
IEC 62366 2007 Medical devices - Application of usability EN 62366 2008
engineering to medical devices
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate 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 INSTRUMENTS or HEARING INSTRUMENT 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
No. Essential Requirements Coverage of EN 60601-2-66
I. GENERAL REQUIREMENTS
1 General Guidance note 2 and 3 shall be observed
1 The devices must be designed and manufactured in The application of EN 60601-2-66
such a way that, when used under the conditions and and the documents referenced in
for the purposes intended, they will not compromise the there (below referenced as “this
clinical condition or the safety of patients, or the safety document” or “this standard”)
and health of users or, where applicable, other support a manufacturer to design
persons, provided that any risks which may be HEARING INSTRUMENTS and HEARING
associated with their intended use constitute INSTRUMENT SYSTEMS (below
acceptable risks when weighed against the benefits to “devices”) in such a way that, when
the patient and are compatible with a high level of used under the conditions and for
protection of health and safety. the purposes intended, they will not
compromise the clinical condition
This shall include:
or the safety of patients, or the
safety and health of users or,
where applicable, other persons,
while accepting only risks
associated with their intended use
that constitute acceptable risks
when weighed against the benefits
to the patient and are compatible
with a high level of protection of
health and safety.
Details and exclusions supporting
this general statement follow in
order of the essential requirements
below.
Where the intended use of devices
exceeds the scope of this
document, the manufacturer may
need to apply additional methods to
achieve conformity to the essential
requirements.
Manufacturing aspects are not
covered by this document! This
statement applies to several
essential requirements below but
will not be repeated at each line, in
order to provide for a better
usability of this document.
– reducing, as far as possible, the risk of use error The application of this document
due to the ergonomic features of the device and (201.7.1.1, 201.12.2 with reference
the environment in which the device is intended to to EN 62366) reduces, as far as
be used (design for patient safety), and possible, the risk of use error due
to the ergonomic features of the
device and the environment in
which the device is intended to be
used.
No. Essential Requirements Coverage of EN 60601-2-66
– consideration of the technical knowledge, This document (201.7.9.1,
experience, education and training and where 201.7.9.2.2) puts consideration of
applicable the medical and physical conditions of the technical knowledge,
intended users (design for lay, professional, experience, education and training
disabled or other users). and where applicable the medical
and physical conditions of intended
users (design for lay, professional,
disabled or other users).
2 General Guidance note 2 and 3 shall be observed
2 The solutions adopted by the manufacturer for the The requirements of this document
design and construction of the devices must conform to for the design and construction of
safety principles, taking account of the generally the devices conform to safety
acknowledged state of the art. principles, taking account of the
generally acknowledged state of

the art at the time it has been
In selecting the most appropriate solutions, the
released (2014).
manufacturer must apply the following principles in the
This document references
following order:
EN ISO 14971, the application of
which (4.3) does provide for the
coverage of potential developments
and new conclusions in hearing aid
safety that became known after the
release of this particular standard.
The requirements of this document
have been established by selecting
the most appropriate solutions to
the particular devices and their
risks, by applying the following
principles in the following order:
– eliminate or reduce risks as far as possible
(inherently safe design and construction),
– where appropriate take adequate protection
measures including alarms if necessary, in relation
to risks that cannot be eliminated,
– inform users of the residual risks due to any
shortcomings of the protection measures adopted.
3 The devices must achieve the performances intended The performance aspect (clinical
by the man
...