IEC TR 62809:2019
(Main)Summary of requirements and tests for products in the scope of IEC 60601-2-66
Summary of requirements and tests for products in the scope of IEC 60601-2-66
IEC TR 62809:2019 is available as IEC TR 62809:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC TR 62809:2019 provides an overview of the requirements and tests of IEC 60601-2-66 in combination with the applicable sections of IEC 60601-1, and the collateral standards of the IEC 60601 series. It is intended to assist various groups involved in the product lifecycles process - like designers and suppliers - to get an overview of the basic requirements without studying all involved standard documents in detail. The table includes not all but just the more common requirements and tests. It is crucial to understand that the summary in this document cannot serve as an input for a product requirement specification or as a test plan without consulting IEC 60601-2-66 itself. This document alone cannot be used to establish or assess compliance to IEC 60601-2-66.
General Information
Relations
Buy Standard
Standards Content (Sample)
IEC TR 62809 ®
Edition 2.0 2019-10
TECHNICAL
REPORT
Summary of requirements and tests to products in the scope of IEC 60601-2-66
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.
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.
IEC TR 62809 ®
Edition 2.0 2019-10
TECHNICAL
REPORT
Summary of requirements and tests to products in the scope of IEC 60601-2-66
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.180.15; 17.140.50 ISBN 978-2-8322-7523-8
– 2 – IEC TR 62809:2019 © IEC 2019
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Summary of requirements and tests . 7
Bibliography . 18
Table 1 – Summary of requirements and tests . 8
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
SUMMARY OF REQUIREMENTS AND TESTS FOR
PRODUCTS IN THE SCOPE OF IEC 60601-2-66
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.
The main task of IEC technical committees is to prepare International Standards. However, a
technical committee may propose the publication of a Technical Report when it has collected
data of a different kind from that which is normally published as an International Standard, for
example "state of the art".
IEC 62809, which is a Technical Report, has been prepared by IEC technical committee 29:
Electroacoustics.
This second edition cancels and replaces the first edition published in 2013. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) introduction of the term FITTED OSPL90 (FITTED MAXIMUM OUTPUT SOUND PRESSURE LEVEL)
(201.3.206 of IEC 60601-2-66:2019);
b) the allowable maximum output sound pressure level is now based on FITTED MAXIMUM
OUTPUT SOUND PRESSURE LEVEL (201.9.6 of IEC 60601-2-66:2019).
c) ESSENTIAL PERFORMANCE is based on risk analysis (201.4.3).
– 4 – IEC TR 62809:2019 © IEC 2019
The text of this Technical Report is based on the following documents:
Draft TR Report on voting
29/1015/DTR 29/1019/RVDTR
Full information on the voting for the approval of this Technical Report 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 document, the following print types are used:
– requirements and definitions: roman type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
: SMALL CAPITALS.
NOTED
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.
A bilingual version of this publication may be issued at a later date.
INTRODUCTION
During the preparation of IEC 60601-2-66, members of the involved technical committee and
working group voiced concerns about the complexity of the document and its structure as part
of the IEC 60601 series. Members felt distracted from the technical content by this complexity
during reviews of the document stages. There was also concern that groups in the hearing aid
community would have problems to understand and apply the standard and that this could be
an issue with its acceptability.
In order to have a broad consensus for the new standard, it was agreed that the standard should
be supported by this Technical Report, which should enable members of the community and
the industry to have a basic understanding of the requirements of the standard, without the
need to study the complete standard document and the documents that are referenced in it.
IEC 60601-2-66 was published to address the specific requirements for safety of hearing aids,
and it is entitled “Particular requirements for the basic safety and essential performance of
hearing aids and hearing aid systems”. It was published because IEC 60601-1 is a general
standard intended to address a wide range of medical electrical equipment – including large
scale facilities such as MRI machines, for example – and thus has large sections that are not
relevant to low-voltage, low power, subminiature hearing aids.
If IEC 60601-2-66 was not published, test and regulatory organizations would probably have
difficulty applying IEC 60601-1, because it does not contain specific guidance for hearing aids.
This Technical Report contains all the requirements from IEC 60601-2-66 which relate to
hearing aids and reduces discussion with those that do not relate to hearing aids.
It includes specific references to the applicable requirements within IEC 60601-1, and it is
suggested that hearing aid designers and manufacturers along with test and regulatory
organizations read this Technical Report as an overview of IEC 60601-2-66.
– 6 – IEC TR 62809:2019 © IEC 2019
SUMMARY OF REQUIREMENTS AND TESTS FOR
PRODUCTS IN THE SCOPE OF IEC 60601-2-66
1 Scope
This document, which is a Technical Report, provides an overview of the requirements and tests
of IEC 60601-2-66 in combination with the applicable sections of IEC 60601-1, and the
collateral standards of the IEC 60601 series.
NOTE The IEC 60601 series consists of three levels of standards: IEC 60601-1, known as the general standard,
several IEC 60601-1-X documents, known as the collateral standards, and a series of particular standards covering
requirements for specific types of equipment (IEC 60601-2-X).
It is intended to assist various groups involved in the product lifecycles process – like designers
and suppliers – to get an overview of the basic requirements without studying all involved
standard documents in detail. The table includes not all but just the more common requirements
and tests.
It is crucial to understand that the summary in this document cannot serve as an input for a
product requirement specification or as a test plan without consulting IEC 60601-2-66 itself.
This document alone cannot be used to establish or assess compliance to IEC 60601-2-66.
The summary in Table 1 below does not preclude the user from reading the referenced
standards in their entirety for a thorough knowledge of the basic safety of hearing aids and
hearing aid systems.
2 Normative references
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.
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
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
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
4 Summary of requirements and tests
The reference column in Table 1 shows the clause number of IEC 60601-2-66:2019 and, if
applicable, the reference to IEC 60601-1:2005, or other documents. References to the
particular standard IEC 60601-2-66:2019 start with the number 201, while references to the
general standard, IEC 60601-1:2005, start directly with the clause or subclause number.
Other documents
...
IEC TR 62809 ®
Edition 2.0 2019-10
REDLINE VERSION
TECHNICAL
REPORT
colour
inside
Summary of requirements and tests to products in the scope of IEC 60601-2-66
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.
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.
IEC TR 62809 ®
Edition 2.0 2019-10
REDLINE VERSION
TECHNICAL
REPORT
colour
inside
Summary of requirements and tests to products in the scope of IEC 60601-2-66
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.180.15; 17.140.50 ISBN 978-2-8322-7556-6
– 2 – IEC TR 62809:2019 RLV © IEC 2019
CONTENTS
FOREWORD . 3
INTRODUCTION . 2
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Summary of requirements and tests . 7
Bibliography . 19
Table 1 – Summary of requirements and tests . 8
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
SUMMARY OF REQUIREMENTS AND TESTS FOR
PRODUCTS IN THE SCOPE OF IEC 60601-2-66
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.
– 4 – IEC TR 62809:2019 RLV © IEC 2019
The main task of IEC technical committees is to prepare International Standards. However, a
technical committee may propose the publication of a Technical Report when it has collected
data of a different kind from that which is normally published as an International Standard, for
example "state of the art".
IEC 62809, which is a Technical Report, has been prepared by IEC technical committee 29:
Electroacoustics.
This second edition cancels and replaces the first edition published in 2013. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) introduction of the term FITTED OSPL90 (FITTED MAXIMUM OUTPUT SOUND PRESSURE LEVEL)
(201.3.206 of IEC 60601-2-66:2019);
b) the allowable maximum output sound pressure level is now based on FITTED MAXIMUM
OUTPUT SOUND PRESSURE LEVEL (201.9.6 of IEC 60601-2-66:2019).
c) ESSENTIAL PERFORMANCE is based on risk analysis (201.4.3).
The text of this Technical Report is based on the following documents:
Draft TR Report on voting
29/1015/DTR 29/1019/RVDTR
Full information on the voting for the approval of this Technical Report 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 document, the following print types are used:
– requirements and definitions: roman type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
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.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this document using a colour printer.
INTRODUCTION
During the preparation of IEC 60601-2-66, members of the involved technical committee and
working group voiced concerns about the complexity of the document and its structure as part
of the IEC 60601 series. Members felt distracted from the technical content by this complexity
during reviews of the document stages. There was also concern that groups in the hearing
instrument aid community would have problems to understand and apply the standard and that
this could be an issue with its acceptability.
In order to have a broad consensus for the new standard, it was agreed that the standard should
be supported by this Technical Report, which should enable members of the community and
the industry to have a basic understanding of the requirements of the standard, without the
need to study the complete standard document and the documents that are referenced in it.
IEC 60601-2-66 was published to address the specific requirements for safety of hearing
instruments aids, and it is entitled “Particular requirements for the basic safety and essential
performance of hearing instruments aids and hearing instruments aid systems”. It was published
because IEC 60601-1 is a general standard intended to address a wide range of medical
electrical equipment – including large scale facilities such as MRI machines, for example – and
thus has large sections that are not relevant to low-voltage, low power, subminiature hearing
instruments aids.
If IEC 60601-2-66 was not published, test and regulatory organizations would probably have
difficulty applying IEC 60601-1, because it does not contain specific guidance for hearing
instruments aids. This Technical Report contains all the requirements from IEC 60601-2-66
which relate to hearing instruments aids and reduces discussion with those that do not relate
to hearing instruments aids.
It includes specific references to the applicable requirements within IEC 60601-1, and it is
suggested that hearing instrument aid designers and manufacturers along with test and
regulatory organizations read this Technical Report as an overview of IEC 60601-2-66.
– 6 – IEC TR 62809:2019 RLV © IEC 2019
SUMMARY OF REQUIREMENTS AND TESTS FOR
PRODUCTS IN THE SCOPE OF IEC 60601-2-66
1 Scope
This document, which is a Technical Report, provides an overview of the requirements and tests
of IEC 60601-2-66 in combination with the applicable sections of IEC 60601-1, and the
collateral standards of the IEC 60601 series.
NOTE The IEC 60601 series consists of three levels of standards: IEC 60601-1, known as the general standard,
several IEC 60601-1-X documents, known as the collateral standards, and a series of particular standards covering
requirements for specific types of equipment (IEC 60601-2-X).
It is intended to assist various groups involved in the product lifecycles process – like designers
and suppliers – to get an overview of the basic requirements without studying all involved
standard documents in detail. The table includes not all but just the more common requirements
and tests.
It is crucial to understand that the summary in this document cannot serve as an input for a
product requirement specification or as a test plan without consulting the standard document
IEC 60601-2-66 itself. This document alone cannot be used to establish or assess compliance
to the standard IEC 60601-2-66.
The summary in Table 1 below does not preclude the user from reading the referenced
standards in their entirety for a thorough knowledge of the basic safety of hearing instruments
aids and hearing instrument aid systems.
2 Normative references
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.
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-2-66:20122019, Medical electrical equipment – Part 2-66: Particular requirements
for the basic safety and essential performance of hearing instruments aids and hearing
instrument aid systems
3 Terms and definitions
No terms and definitions are listed in this
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.