IEC TR 62809:2013
(Main)Summary of requirements and tests to products in the scope of IEC 60601-2-66
Summary of requirements and tests to products in the scope of IEC 60601-2-66
IEC/TR 62809:2013(E) 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. 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. There was also concern that groups in the hearing instrument 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. 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 itself. This Technical Report alone cannot be used to establish or assess compliance to the standard. Keywords: hearing instruments, hearing aids, hearing
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IEC/TR 62809 ®
Edition 1.0 2013-01
TECHNICAL
REPORT
Summary of requirements and tests for products in the scope of IEC 60601-2-66
IEC/TR 62809:2013(E)
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IEC/TR 62809 ®
Edition 1.0 2013-01
TECHNICAL
REPORT
Summary of requirements and tests for products in the scope of IEC 60601-2-66
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
Q
ICS 11.180.15; 17.140.50 ISBN 978-2-83220-618-8
– 2 – TR 62809 © IEC:2013(E)
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
1 Scope . 6
2 Normative references . 6
3 Summary of requirements and tests . 6
Bibliography . 17
Table 1 – Summary of requirements and tests . 7
TR 62809 © IEC:2013(E) – 3 –
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
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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.
The text of this technical report is based on the following documents:
Enquiry draft Report on voting
29/776/DTR 29/791/RVC
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.
– 4 – TR 62809 © IEC:2013(E)
In this standard, 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.
A bilingual version of this publication may be issued at a later date.
TR 62809 © IEC:2013(E) – 5 –
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 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, and it is entitled “Particular requirements for the basic safety and essential
performance of hearing instruments and hearing instruments 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.
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. This Technical Report contains all the requirements from IEC 60601-2-66 which
relate to hearing instruments, and reduces discussion with those that do not relate to hearing
instruments.
It includes specific references to the applicable requirements within IEC 60601-1, and it is
suggested that hearing instrument designers and manufacturers along with test and
regulatory organizations read this Technical Report as an overview of IEC 60601-2-66.
– 6 – TR 62809 © IEC:2013(E)
SUMMARY OF REQUIREMENTS AND TESTS FOR
PRODUCTS IN THE SCOPE OF IEC 60601-2-66
1 Scope
This 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
itself. This Technical Report alone cannot be used to establish or assess compliance to the
standard.
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
and hearing instrument 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 60601-2-66:2012, Medical electrical equipment – Part 2-66: Particular requirements for
the basic safety and essential performance of hearing instruments and hearing instrument
systems
3 Summary of requirements and tests
The reference column in Table 1 shows the clause number of IEC 60601-2-66:2012 and, if
applicable the reference to IEC 60601-1:2005, or other documents. References to the
particular standard, IEC 60601-2-66:2012 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 will be referred to explicitly. Some detailed references, for example
describing tools, are placed in the text instead of in the reference column.
TR 62809 © IEC:2013(E) – 7 –
Table 1 – Summary of requirements and tests
Reference Subject Requirements and tests
201.1.1 ACCESSORY Requirements:
201.8 ACCESSORIES to HEARING INSTRUMENTS (e.g. remote control units,
audio streamers, battery chargers, power supplies) need to have
documented proof of compliance to IEC 60065, IEC 60950-1, the
IEC 60601-1 or other applicable IEC safety standards. They form a
HEARING INSTRUMENT SYSTEM when connected to the HEARING
INSTRUMENT. Wherever this connection has an influence on the
compliance to the requirements of IEC 60601-2-66 the HEARING
INSTRUMENT has to pass the requirements while being connected to
the ACCESSORY. If this connection results in additional requirements
to the ACCESSORY, these requirements have to be fulfilled beyond the
applicable IEC standards.
Programming interfaces or ACCESSORIES in a clinic
...
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