SIST EN 60601-2-66:2013
(Main)Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems
Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems
This International Standard applies to the BASIC SAFETY of HEARING INSTRUMENTS and HEARING INSTRUMENT SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. If a clause or subclause is specifically intended to be applicable to HEARING INSTRUMENTS only, or to HEARING INSTRUMENT SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to HEARING INSTRUMENTS and to HEARING INSTRUMENT SYSTEMS, as relevant. 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. Alternatively the general standard may be applied. HEARING INSTRUMENTS do not have a MAINS PART intended for connection to a.c. SUPPLY MAINS. The connection to the SUPPLY MAINS of a HEARING INSTRUMENT system is covered by power supply, charger or other types of ACCESSORIES. 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. Programming interfaces or ACCESSORIES in a clinical application are covered by the general standard.
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
La CEI 60601-2-66:2012 s'applique à la sécurité de base des instruments d'audition et des systèmes d'audition. Les dangers inhérents à la fonction physiologique prévue des instruments d'audition ou des systèmes d'audition dans le cadre du domaine d'application de la présente norme ne sont pas couverts par des exigences spécifiques contenues dans la présente norme, à l'exception de 201.7.9.2 et de 201.9.6. Les accessoires des instruments d'audition dans l'environnement des soins à domicile (par exemple, unités de commande à distance, diffuseurs de flux audio, chargeurs de batteries, alimentations) sont couverts par la norme qui s'applique le plus, la CEI 60065, la CEI 60950-1 ou d'autres normes de sécurité CEI applicables. Les accessoires connectés aux instruments d'audition peuvent former des systèmes d'audition. Seuls les instruments d'audition et leurs parties amovibles sont soumis à tous les articles applicables de cette norme particulière. Les autres éléments des systèmes d'audition sont soumis aux exigences de cette norme particulière de par leur connexion aux systèmes d'audition. La présente norme ne s'applique pas: - aux implants cochléaires ou autres instruments d'audition implantés; - aux instruments d'audition à conduction osseuse; - aux instruments d'audition de formation (c'est-à-dire les instruments auditifs de groupe, les dispositifs d'entraînement auditif, etc.); - à l'application d'un instrument d'audition à la mesure des niveaux d'audition. La CEI 60645-1 s'applique; - aux systèmes de boucles d'induction audiofréquences ou à leurs composants, tels que décrits dans la CEI 60118-4 et la CEI 62489-1; - aux systèmes d'audition à assistance fonctionnant par infrarouge ou radio; - et à la fonction de génération acoustique d'un masqueur d'acouphène.
Medicinska električna oprema - 2-66. del: Zahteve za osnovno varnost in bistvene lastnosti slušnih pripomočkov in sistemov slušnih instrumentov
Ta mednarodni 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 z 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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 60601-2-66:2013
01-marec-2013
0HGLFLQVNDHOHNWULþQDRSUHPDGHO =DKWHYH]DRVQRYQRYDUQRVWLQELVWYHQH
ODVWQRVWLVOXãQLKSULSRPRþNRYLQVLVWHPRYVOXãQLKLQVWUXPHQWRY
Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and
essential performance of hearing instruments and hearing instrument systems
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
Ta slovenski standard je istoveten z: EN 60601-2-66:2013
ICS:
11.180.15 3ULSRPRþNL]DJOXKHRVHEHLQ Aids for deaf and hearing
RVHEH]RNYDURVOXKD impaired people
SIST EN 60601-2-66:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 60601-2-66:2013
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SIST EN 60601-2-66:2013
EUROPEAN STANDARD
EN 60601-2-66
NORME EUROPÉENNE
January 2013
EUROPÄISCHE NORM
ICS 11.180.15; 17.140.50
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 60601-2-66:2012)
Appareils électromédicaux - Medizinische elektrische Geräte -
Partie 2-66: Exigences particulières pour Teil 2-66: Besondere Festlegungen für die
la sécurité de base et les performances Sicherheit einschließlich der wesentlichen
essentielles des instruments d'audition Leistungsmerkmale von Hörgeräten
et systèmes d'audition und Hörgerätesystemen
(CEI 60601-2-66:2012) (IEC 60601-2-66:2012)
This European Standard was approved by CENELEC on 2012-11-06. 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.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Management Centre: Avenue Marnix 17, B - 1000 Brussels
© 2013 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-66:2013 E
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SIST EN 60601-2-66:2013
EN 60601-2-66:2013 - 2 -
Foreword
The text of document 29/777/FDIS, future edition 1 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 60601-2-66:2013.
The following dates are fixed:
(dop) 2013-08-06
• latest date by which the document has
to be implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2015-11-06
• latest date by which the national
standards conflicting with the
document have to be withdrawn
This standard is to be read in conjunction with EN 60601-1:2006.
In this standard, the following print types are used:
- Requirements and definitions: roman type.
- Test specifications: italic type.
- Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of
tables is also in a smaller type.
- TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED:
SMALL CAPITALS.
In referring to the structure of this standard, the term
- “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of
all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.),
- “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses
of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the clause
number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the
ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb:
- “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
- “should” means that compliance with a requirement or a test is recommended but is not mandatory
for compliance with this standard;
- “may” is used to describe a permissible way to achieve compliance with a requirement or test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
that there is guidance or rationale related to that item in Annex AA.
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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 60601-2-66:2012 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 60118-4:2006 NOTE Harmonised as EN 60118-4:2006 (not modified).
IEC 60318-5:2006 NOTE Harmonised as EN 60318-5:2006 (not modified).
IEC 60601-1-4:1996 NOTE Harmonised as EN 60601-1-4:1996 (not modified).
IEC 60645-1:2001 NOTE Harmonised as EN 60645-1:2001 (not modified).
IEC 61672-1:2002 NOTE Harmonised as EN 61672-1:2003 (not modified).
IEC 62489-1:2010 NOTE Harmonised as EN 62489-1:2010 (not modified).
ISO 80000-8:2007 NOTE Harmonised as EN ISO 80000-8:2007 (not modified).
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SIST EN 60601-2-66:2013
EN 60601-2-66:2013 - 4 -
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
Annex ZA of EN 60601-1:2006 applies, except as follows:
In Annex ZA of EN 60601-1:2006 replace the introductory paragraph by the following:
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 When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Publication Year Title EN/HD Year
In Annex ZA of EN 60601-1:2006 replace IEC 60950-1:2001 by:
IEC 60950-1 (mod) 2005 Information technology equipment - Safety - EN 60950-1 2006
+ corr. August 2006 Part 1: General requirements + AC:2011 2011
+ A11 2009
+ A12 2011
Add to Annex ZA of EN 60601-1:2006 the following new references:
IEC 60065 (mod) 2001 Audio, video and similar electronic apparatus EN 60065 2002
+ corr. August 2002 - Safety requirements + corr. August 2007
+ A11 2008
+ A12 2011
IEC 60118-7 2005 Electroacoustics - Hearing aids - EN 60118-7 2005
Part 7: Measurement of the performance
characteristics of hearing aids for production,
supply and delivery quality assurance
purposes
IEC 60118-13 - Electroacoustics - Hearing aids - EN 60118-13 -
Part 13: Electromagnetic compatibility (EMC)
IEC 60601-1-11 2010 Medical electrical equipment - EN 60601-1-11 2010
+ corr. April 2011 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 EN 62304 -
life-cycle processes
IEC 62366 2007 Medical devices - Application of usability EN 62366 2008
engineering to medical devices
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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 and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EU Directive 93/42/EEC except the
following:
– Essential Requirements 1 to 7.1
– Essential Requirement 7.4
– Essential Requirement 7.5, Paragraphs 2 and 3
– Essential Requirement 13.6 (q)
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives may be applicable to the products falling
within the scope of this standard.
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SIST EN 60601-2-66:2013
IEC 60601-2-66
®
Edition 1.0 2012-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-66: Particular requirements for the basic safety and essential performance
of hearing instruments and hearing instrument systems
Appareils électromédicaux –
Partie 2-66: Exigences particulières pour la sécurité de base et les performances
essentielles des instruments d'audition et systèmes d'audition
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX X
ICS 11.180.15; 17.140.50 ISBN 978-2-83220-381-1
Warning! Make sure that you obtained this publication from an authorized distributor.
Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
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SIST EN 60601-2-66:2013
– 2 – 60601-2-66 © IEC:2012
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 6
201.2 Normative references . 8
201.3 Terms and definitions . 9
201.4 General requirements . 10
201.5 General requirements for testing ME EQUIPMENT . 11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 13
201.8 *Protection against electrical HAZARDS from ME EQUIPMENT . 18
201.9 *Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 21
201.10 Protection against unwanted and excessive radiation HAZARDS . 23
201.11 *Protection against excessive temperatures and other HAZARDS . 23
201.12 *Accuracy of controls and instruments and protection against hazardous
outputs . 24
201.13 *HAZARDOUS SITUATIONS and fault conditions . 25
201.14 *PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 28
201.15 *Construction of ME EQUIPMENT . 28
201.16 *ME SYSTEMS . 30
201.17 *Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 31
Annexes . 32
Annex E (informative) Examples of the connection of the measuring device (MD) for
measurement of the PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT . 32
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 32
Annex H (informative) PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE and
documentation . 32
Annex I (informative) ME SYSTEMS aspects . 32
Annex J (informative) Survey of insulation paths . 33
Annex K (informative) Simplified PATIENT LEAKAGE CURRENT diagrams . 33
Annex L (normative) Insulated winding wires for use without interleaved insulation . 33
Annex AA (informative) Particular guidance and rationale . 34
Annex BB (informative) Abbreviations . 39
Bibliography . 40
Index of defined terms used in this particular standard . 41
Figure 201.101 – Measuring circuit for the LEAKAGE CURRENT . 20
Table 201.102 – MECHANICAL HAZARDS to be considered . 21
Table AA.101 – Summary of the approach of this standard . 35
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SIST EN 60601-2-66:2013
60601-2-66 © IEC:2012 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-66: Particular requirements for the basic safety and essential
performance of hearing instruments and hearing instrument systems
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-66 has been prepared by IEC technical committee 29:
Electroacoustics.
The text of this particular standard is based on the following documents:
FDIS Report on voting
29/777/FDIS 29/792/RVD
Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
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SIST EN 60601-2-66:2013
– 4 – 60601-2-66 © IEC:2012
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
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SIST EN 60601-2-66:2013
60601-2-66 © IEC:2012 – 5 –
INTRODUCTION
In 1998 the HEARING INSTRUMENT industry represented by the EHIMA attempted to establish a
standard with the main purpose of providing manufacturers with a guide to demonstrate
conformity with the European Medical Devices Directive 93/42/EEC.
The document prEN 50220 failed CENELEC vote and was published as “EHIMA standard” in
June 1998 with almost identical content. EHIMA concluded in 2009 that the requirements of
that standard were no longer up to date and an internationally accepted standard for HEARING
INSTRUMENT safety published by IEC or ISO to demonstrate compliance with regulatory
requirements should be produced.
This resulting IEC standard amends and supplements IEC 60601-1 (third edition, 2005):
Medical electrical equipment – Part 1: General requirements for safety and essential
performance, hereinafter referred to as ‘the general standard’.
Figures in square brackets refer to the Bibliography.
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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
201.1 Scope, object and related standards
1
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This International Standard applies to the BASIC SAFETY of HEARING INSTRUMENTS and HEARING
INSTRUMENT SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM.
If a clause or subclause is specifically intended to be applicable to HEARING INSTRUMENTS only,
or to HEARING INSTRUMENT SYSTEMS only, the title and content of that clause or subclause will
say so. If that is not the case, the clause or subclause applies both to HEARING INSTRUMENTS
and to HEARING INSTRUMENT SYSTEMS, as relevant.
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.
NOTE See also 201.4.2. (RISK MANAGEMENT).
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.
Alternatively the general standard may be applied. HEARING INSTRUMENTS do not have a MAINS
PART intended for connection to a.c. SUPPLY MAINS. The connection to the SUPPLY MAINS of a
HEARING INSTRUMENT system is covered by power supply, charger or other types of
ACCESSORIES.
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.
Programming interfaces or ACCESSORIES in a clinical application are covered by the general
standard.
NOTE Detachable parts of HEARING INSTRUMENTS even if supplied separately (e.g. ear hooks, domes, wax guards
etc.), are not regarded as ACCESSORIES.
This standard does not apply to:
– cochlear implants or other implanted HEARING INSTRUMENTS;
– bone conduction HEARING INSTRUMENTS;
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1
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance.
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60601-2-66 © IEC:2012 – 7 –
– 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;
– the sound generating function of a tinnitus masker.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY requirements for
HEARING INSTRUMENTS and HEARING INSTRUMENT SYSTEMS as defined in 201.3.202 and
201.3.203.
201.1.3 * Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard.
IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-9, IEC 60601-1-10, and IEC 60601-1-11 do not
apply. All other published collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are
specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
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"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make referenc
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