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

IEC 60601-2-66:2012 International Standard applies to the basic safety of hearing instruments and hearing instrument systems. 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. 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. This standard does not apply to: - cochlear implants or other implanted hearing instruments; - bone conduction hearing instruments; - 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; - and the sound generating function of a tinnitus masker.

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

• Status: Withdrawn
• Publication Date: 17-Jan-2013
• Withdrawal Date: 05-Nov-2015
• 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: 31-Jul-2018
• Completion Date: 31-Jul-2018
• 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 60601-2-66:2013 - Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems

Relations

• Replaced By: 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
• Effective Date: 01-Dec-2015

Standards Content (Sample)

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

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
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
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.

- 3 - 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 60601-2-66:2012 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).

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

- 5 - EN 60601-2-66:2013
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.

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

– 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 .
...