IEC TR 62809:2019

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

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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
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– 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
...