IEC 60601-2-66:2019
(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.
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.
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IEC 60601-2-66 ®
Edition 3.0 2019-10
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-66: Particular requirements for the basic safety and essential
performance of hearing instruments aids and hearing instrument aids systems
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
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3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.
IEC publications search - webstore.iec.ch/advsearchform Electropedia - www.electropedia.org
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variety of criteria (reference number, text, technical containing more than 22 000 terminological entries in English
committee,…). It also gives information on projects, replaced and French, with equivalent terms in 16 additional languages.
and withdrawn publications. Also known as the International Electrotechnical Vocabulary
(IEV) online.
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IEC 60601-2-66 ®
Edition 3.0 2019-10
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-66: Particular requirements for the basic safety and essential
performance of hearing instruments aids and hearing instrument aids systems
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.180.15; 17.140.50 ISBN 978-2-8322-7543-6
– 2 – IEC 60601-2-66:2019 RLV © IEC 2019
CONTENTS
FOREWORD . 4
INTRODUCTION . 2
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions . 11
201.4 General requirements . 13
201.5 General requirements for testing ME EQUIPMENT . 14
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 15
201.7 ME EQUIPMENT identification, marking and documents . 16
201.8 * Protection against electrical HAZARDS from ME EQUIPMENT . 21
201.9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 24
201.10 * Protection against unwanted and excessive radiation HAZARDS . 26
201.11 * Protection against excessive temperatures and other HAZARDS . 26
201.12 * Accuracy of controls and instruments and protection against hazardous
outputs. 28
201.13 * HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 29
201.14 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 32
201.15 * Construction of ME EQUIPMENT . 32
201.16 * ME SYSTEMS . 34
201.17 * Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 35
Annexes . 36
Annex E (informative) Examples of the connection of the measuring device (MD) for
measurement of the PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT . 37
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 38
Annex H (informative) PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE and
documentation . 39
Annex I (informative) ME SYSTEMS aspects . 40
Annex J (informative) Survey of insulation paths . 41
Annex K (informative) Simplified PATIENT LEAKAGE CURRENT diagrams . 42
Annex L (normative) Insulated winding wires for use without interleaved insulation . 43
Annex AA (informative) Particular guidance and rationale . 44
Annex BB (informative) Abbreviations . 50
Annex CC (informative) Essential performance . 51
Annex DD (informative) Electromagnetic compatibility of ME EQUIPMENT . 52
Bibliography . 54
Index of defined terms used in this particular standard . 56
Figure 201.101 – Measuring circuit for LEAKAGE CURRENT (see 201.8.7.4.7) . 23
Table 201.101 – MECHANICAL HAZARDS to be considered . 25
Table AA.101 – Summary of the approach of this document . 45
Table DD.101 – Example of applicable standards for HEARING AID specific setting for
RF radiated emissions . 52
Table DD.102 – Example of applicable tests . 53
– 4 – IEC 60601-2-66:2019 RLV © IEC 2019
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-66: Particular requirements for the basic safety and essential
performance of hearing instruments aids
and hearing instrument aid 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.
This redline version of the official IEC Standard allows the user to identify the changes
made to the previous edition. A vertical bar appears in the margin wherever a change has
been made. Additions are in green text, deletions are in strikethrough red text.
International Standard IEC 60601-2-66 has been prepared by IEC technical committee 29:
Electroacoustics.
This third edition 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.
The text of this International Standard is based on the following documents:
FDIS Report on voting
29/1023/FDIS 29/1030/RVD
Full information on the voting for the approval of this International Standard can be found in the
report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document, 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 document, 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 document are preceded by the term "Clause" followed by the
clause number. References to subclauses within this particular standard are by number only.
In this document, 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 document conform to usage described in Clause 7 of the ISO/IEC
Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance with
this document;
– "should" means that compliance with a requirement or a test is recommended but is not
ma
...
IEC 60601-2-66 ®
Edition 3.0 2019-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-66: Particular requirements for the basic safety and essential
performance of hearing aids and hearing aid systems
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
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.
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ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.
IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.
IEC publications search - webstore.iec.ch/advsearchform Electropedia - www.electropedia.org
The advanced search enables to find IEC publications by a The world's leading online dictionary on electrotechnology,
variety of criteria (reference number, text, technical containing more than 22 000 terminological entries in English
committee,…). It also gives information on projects, replaced and French, with equivalent terms in 16 additional languages.
and withdrawn publications. Also known as the International Electrotechnical Vocabulary
(IEV) online.
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published IEC Glossary - std.iec.ch/glossary
details all new publications released. Available online and 67 000 electrotechnical terminology entries in English and
once a month by email. French extracted from the Terms and Definitions clause of
IEC publications issued since 2002. Some entries have been
IEC Customer Service Centre - webstore.iec.ch/csc collected from earlier publications of IEC TC 37, 77, 86 and
If you wish to give us your feedback on this publication or CISPR.
need further assistance, please contact the Customer Service
Centre: sales@iec.ch.
A propos de l'IEC
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Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.
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IEC 60601-2-66 ®
Edition 3.0 2019-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-66: Particular requirements for the basic safety and essential
performance of hearing aids and hearing aid systems
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
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.180.15; 17.140.50 ISBN 978-2-8322-7350-0
– 2 – IEC 60601-2-66:2019 © IEC 2019
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions . 11
201.4 General requirements . 12
201.5 General requirements for testing ME EQUIPMENT . 13
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 15
201.7 ME EQUIPMENT identification, marking and documents . 15
201.8 * Protection against electrical HAZARDS from ME EQUIPMENT . 21
201.9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 23
201.10 * Protection against unwanted and excessive radiation HAZARDS . 25
201.11 * Protection against excessive temperatures and other HAZARDS . 25
201.12 * Accuracy of controls and instruments and protection against hazardous
outputs. 27
201.13 * HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 28
201.14 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 30
201.15 * Construction of ME EQUIPMENT . 31
201.16 * ME SYSTEMS . 33
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 33
Annexes . 35
Annex E (informative) Examples of the connection of the measuring device (MD) for
measurement of the PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT . 36
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 37
Annex H (informative) PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE and
documentation . 38
Annex I (informative) ME SYSTEMS aspects . 39
Annex J (informative) Survey of insulation paths . 40
Annex K (informative) Simplified PATIENT LEAKAGE CURRENT diagrams . 41
Annex L (normative) Insulated winding wires for use without interleaved insulation . 42
Annex AA (informative) Particular guidance and rationale . 43
Annex BB (informative) Abbreviations . 48
Annex CC (informative) Essential performance . 49
Annex DD (informative) Electromagnetic compatibility of ME EQUIPMENT . 50
Bibliography . 52
Index of defined terms used in this particular standard . 54
Figure 201.101 – Measuring circuit for LEAKAGE CURRENT (see 201.8.7.4.7) . 22
Table 201.101 – MECHANICAL HAZARDS to be considered . 24
Table AA.101 – Summary of the approach of this document . 44
Table DD.101 – Example of applicable standards for HEARING AID specific setting for
RF radiated emissions . 50
Table DD.102 – Example of applicable tests . 51
– 4 – IEC 60601-2-66:2019 © IEC 2019
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-66: Particular requirements for the basic safety and essential
performance of hearing aids and hearing aid 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
...
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