IEC TR 62809:2019

Summary of requirements and tests for products in the scope of IEC 60601-2-66

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

• Status: Published
• Publication Date: 21-Oct-2019
• ICS: 11.180.15 - Aids for deaf and hearing impaired people
• ICS: 17.140.50 - Electroacoustics
• Technical Committee: TC 29 - Electroacoustics
• Drafting Committee: WG 13 - TC 29/WG 13
• Current Stage: PPUB - Publication issued
• Start Date: 22-Oct-2019
• Completion Date: 05-Nov-2019

Relations

• Revises: IEC TR 62809:2013 - Summary of requirements and tests to products in the scope of IEC 60601-2-66
• Effective Date: 05-Sep-2023

Overview - IEC TR 62809:2019 (Summary of requirements and tests)

IEC TR 62809:2019 is a Technical Report published by the IEC that provides a concise overview of the requirements and tests from IEC 60601-2-66 (particular requirements for hearing instrument aids) together with applicable sections of IEC 60601-1 and the IEC 60601 collateral standards. This edition (Edition 2.0, 2019) is a redline/summary document intended to help stakeholders quickly understand the more common requirements and test topics without reading all full standard texts. It is not a substitute for the full standards and cannot be used alone to establish or assess compliance.

Key topics and technical requirements

The TR summarizes practical, commonly referenced requirements and tests, including:

• Accessories: Requirements for accessories (remote controls, chargers, power supplies, streamers) and when an accessory forms a hearing instrument aid system. Documentation and safety-standard compliance for accessories are highlighted.
• Type tests: Guidance on representative sampling, family testing strategies, and testing under least-favourable and reasonably foreseeable misuse conditions.
• Risk management: Requirement to apply a formal risk management process (ISO 14971). Where IEC 60601-2-66 addresses particular risks, alternative mitigations are acceptable if residual risk is justified.
• Essential performance: Identification of functions considered essential performance must be done via the manufacturer’s risk analysis.
• Expected service life: Manufacturers must state expected service life in the risk management file.
• Components and reliability: Use of components whose failure could create hazards must follow their ratings and relevant IEC/ISO safety requirements; means of protection must be assessed for reliability.
• Markings and durability: Markings must remain legible for expected service life and resist cleaning solvents and handling.
• Edition-specific changes called out in this TR include the introduction of FITTED OSPL90 (fitted maximum output sound pressure level) and that allowable output limits are based on fitted output; also that essential performance is determined by risk analysis.

Practical applications - who uses this TR

This Technical Report is aimed at:

• Designers and manufacturers of hearing instrument aids for early-stage product planning and design reviews.
• Suppliers and accessory vendors to understand interaction and system-level requirements.
• Test labs and regulatory assessors as an overview to focus testing and documentation efforts before consulting full standards.
• Quality and compliance teams preparing risk management files and technical documentation.

How to use this TR (and limitations)

• Use IEC TR 62809:2019 as a summary and roadmap to the relevant clauses of IEC 60601-2-66 and IEC 60601-1.
• Do not use the TR alone to write product requirements, test plans, or to certify compliance - always consult the full IEC 60601-2-66 and referenced standards.

Related standards (selected)

• IEC 60601-2-66 (particular requirements for hearing instrument aids)
• IEC 60601-1 (general medical electrical equipment)
• IEC 60601 collateral standards (IEC 60601-1-X)
• ISO 14971 (risk management for medical devices)
• IEC 60065 / IEC 60950-1 / IEC 62368-1 (safety standards relevant to accessories)

Keywords: IEC TR 62809:2019, IEC 60601-2-66, hearing instrument aids, medical electrical equipment, risk management, type tests, essential performance, FITTED OSPL90, compliance.

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.: [phone]
3, rue de Varembé [e-mail]
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: [e-mail].
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 will be referred to explicitly. Some detailed references, for example describing
tools, are placed in the text instead of in the reference column.

– 8 – IEC TR 62809:2019 © IEC 2019
Table 1 – Summary of requirements and tests
Reference Subject Requirements and tests
201.1.1 ACCESSORY Requirements:
201.8 ACCESSORIES TO HEARING AIDS (e.g. remote-control units, audio
streamers, battery chargers, power supplies) need to have documented
proof of compliance to IEC 60065, IEC 60950-1, IEC 62368-1 or other
applicable IEC safety standards. They form a HEARING AID SYSTEM when
connected to the HEARING AID. Wherever this connection has an
influence on the compliance to the requirements of IEC 60601-2-66, the
HEARING AID has to pass the requirements while being connected to the
ACCESSORY. If this connection results in additional requirements to the
ACCESSORY, these requirements shall be fulfilled beyond the applicable
IEC standards.
Programming interfaces or ACCESSORIES in a clinical application are
covered by IEC 60601 (all parts).
For HEARING AIDS that are supplied by an external power source: If a
particular separate power supply is specified, then the relevant tests
are performed with the HEARING AIDS connected to it. If a generic
separate power supply is specified, then the specification in the
ACCOMPANYING DOCUMENTS is inspected.
Tests:
ACCESSORY documentation, test configuration
Inspection of
201.4.1 Type tests TYPE TESTS are performed on a representative sample of the item being
tested. If multiple products are under consideration, which have a
201.4
similar mechanical and electrical architecture, then an engineering
analysis by the MANUFACTURER may justify a single representative
Clause 4
sample for a family of products.
Clause 5
Testing conditions shall consider not just NORMAL USE but also
reasonably foreseeable misuse. Misuse and faults shall be the subject
and results of the RISK ANALYSIS. The instructions for use shall be
considered in testing conditions.
The equipment is tested under the least favorable working conditions.
4.2 Risk management Requirements:
4.5 A RISK MANAGEMENT complying with ISO 14971 shall be performed.
ISO 14971 Where IEC 60601-2-66 specifies requirements addressing particular
RISKS, alternative means of addressing these RISKS are acceptable
provided that the MANUFACTURER can justify that the RESIDUAL RISKS are
the same or lower.
Tests:
Inspection of the RISK MANAGEMENT FILE.
201.4.3 Essential Requirements;
performance
4.3 After a careful consideration of the clauses within this document, it was
decided that they all deal with BASIC SAFETY as defined in the general
standard. Manufacturers have the ability to identify functions of HEARING
AIDS which are considered ESSENTIAL PERFORMANCE in accordance with
their RISK MANAGEMENT PROCESS.
Expected service
4.4 Requirements:
life
The MANUFACTURER shall state the EXPECTED SERVICE LIFE of the
HEARING AID in the RISK MANAGEMENT FILE.
Tests:
Inspection of the RISK MANAGEMENT FILE.
4.8 Components Requirements:
4.9 Components the failure of which could result in a HAZARDOUS SITUATION
shall be used in accordance with their specified ratings. The reliability
of components that are used as MEANS OF PROTECTION shall be
assessed. They shall comply with the applicable safety requirements of
a relevant IEC or ISO standard (options see 4.8).
Tests:
Inspection and, where necessary, test.

Reference Subject Requirements and tests
7.1.3 Durability of Requirements:
markings
Markings shall be removable only with a TOOL or by appreciable force
and shall be sufficiently durable to remain CLEARLY LEGIBLE during
EXPECTED SERVICE LIFE.
Tests:
Markings are rubbed by hand, without undue pressure, first for 15 s with
a cloth rag soaked with distilled water, then for 15 s with a cloth rag
soaked with methylated spirit and then for 15 s with a cloth rag soaked
with isopropyl alcohol.
201.7.1.2 Legibility of Requirements:
201.7.2.1 markings
Markings shall be CLEARLY LEGIBLE when it is placed in the hand.
The serial number and other markings shall be legible utilizing an
optical aid if necessary.
If the size of the HEARING AID does not allow affixation of all required
markings, the markings shall be recorded in full in the ACCOMPANYING
DOCUMENTS or instructions for use (IFU).
Tests:
Inspection and verification of the applicable requirements.
201.7.2.2 Markings Requirements:
7.3.3 HEARING AIDS shall be marked with:
– the name or trademark of the MANUFACTURER;
7.4.2
– a MODEL OR TYPE REFERENCE.
7.8.2
HEARING AIDS shall be marked visibly on the outside or at a user
accessible location (e.g. battery drawer), with:
– if needed: identification of right and left HEARING AID.
Right = red. Left = blue;
– serial number.
HEARING AIDS worn in the ear: The marking on the HEARING AID may be
reduced to the serial number and the identification of right and left.
The type of battery and the mode of insertion shall be marked on
HEARING AIDS unless the design of the battery compartment prevents
incorrect replacement of a battery
Different positions of control devices and switches shall be indicated by
figures, letters or other visual means.
If the change of setting of a control could result in a RISK, such controls
shall be provided with an indicating device or an indication of the
direction in which the magnitude of the function changes.
The color red shall be used only for emergency controls.
Tests:
Inspection and verification of the applicable requirements.
201.7.2.17 Protective Requirements:
packaging
If special handling measures have to be taken during transport or
storage, the packaging shall be marked accordingly.
Tests:
Inspection and verification of the applicable requirements.
201.7.8.1 ACCOMPANYING Requirements:
DOCUMENTS
201.7.9 HEARING AIDS shall be accompanied by instructions containing at least:
– the purpose and INTENDED USE of the HEARING AID;
7.6.1
– instructions for use, operating functions and a technical description;
– easily understood diagrams, illustrations, or photographs of the
fully assemble
...

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.: [phone]
3, rue de Varembé [e-mail]
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: [e-mail].
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 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 60601-2-66:20122019 and,
if applicable, the reference to IEC 60601-1:2005, or other documents. References to the
particular standard IEC 60601-2-66:20122019 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.

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Table 1 – Summary of requirements and tests
Reference Subject Requirements and tests
201.1.1 ACCESSORY Requirements:
201.8 ACCESSORIES TO HEARING INSTRUMENTS AIDS (e.g. remote-control units,
audio streamers, battery chargers, power supplies) need to have
documented proof of compliance to IEC 60065, IEC 60950-1,
IEC 60601-1 IEC 62368-1 or other applicable IEC safety standards.
They form a HEARING INSTRUMENT AID SYSTEM when connected to the
HEARING INSTRUMENT AID. Wherever this connection has an influence on
the compliance to the requirements of IEC 60601-2-66, the HEARING
INSTRUMENT AID 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 shall be fulfilled beyond the
applicable IEC standards.
Programming interfaces or ACCESSORIES in a clinical application are
covered by IEC 60601 (all parts).
For HEARING INSTRUMENTS AIDS that are supplied by an external power
source: If a particular separate power supply is specified, then the
relevant tests are performed with the HEARING INSTRUMENTS AIDS
connected to it. If a generic separate power supply is specified, then
the specification in the ACCOMPANYING DOCUMENTS is inspected.
Tests:
Inspection of ACCESSORY documentation, test configuration
201.4.1 Type tests TYPE TESTS are performed on a representative sample of the item being
tested. If multiple products are under consideration, which have a
201.4
similar mechanical and electrical architecture, then an engineering
analysis by the MANUFACTURER may justify a single representative
Clause 4
sample for a family of products.
Clause 5
Testing conditions shall consider not just NORMAL USE but also
reasonably foreseeable misuse. Misuse and faults shall be the subject
and results of the RISK ANALYSIS. The instructions for use have to shall
be considered in testing conditions.
The equipment is tested under the least favorable working conditions.
4.2 Risk Requirements:
management
4.5 A RISK MANAGEMENT complying with ISO 14971 shall be performed.
ISO 14971 Where IEC 60601-2-66 specifies requirements addressing particular
RISKS, alternative means of addressing these RISKS are acceptable
provided that the MANUFACTURER can justify that the RESIDUAL RISKS are
the same or lower.
Tests:
Inspection of the RISK MANAGEMENT FILE.
201.4.3 Essential Requirements;
performance
4.3 After a careful consideration of the clauses within this document, it was
decided that they all deal with BASIC SAFETY as defined in the general
standard. Manufacturers have the ability to identify functions of HEARING
AIDS which are considered ESSENTIAL PERFORMANCE in accordance with
their RISK MANAGEMENT PROCESS.
4.4 Expected Requirements:
service life
The MANUFACTURER shall state the EXPECTED SERVICE LIFE of the
HEARING INSTRUMENT AID in the RISK MANAGEMENT FILE.
Tests:
Inspection of the RISK MANAGEMENT FILE.

Reference Subject Requirements and tests
4.8 Components Requirements:
4.9 Components the failure of which could result in a HAZARDOUS SITUATION
shall be used in accordance with their specified ratings. The reliability
of components that are used as MEANS OF PROTECTION shall be
assessed. They shall comply with the applicable safety requirements of
a relevant IEC or ISO standard (options see 4.8).
Tests:
Inspection and, where necessary, test.
7.1.3 Durability of Requirements:
markings
Markings shall be removable only with a TOOL or by appreciable force
and shall be sufficiently durable to remain CLEARLY LEGIBLE during
EXPECTED SERVICE LIFE.
Tests:
Markings are rubbed by hand, without undue pressure, first for 15 s with
a cloth rag soaked with distilled water, then for 15 s with a cloth rag
soaked with methylated spirit and then for 15 s with a cloth rag soaked
with isopropyl alcohol.
201.7.1.2 201.7.2.1 Legibility of Requirements:
markings
Markings shall be CLEARLY LEGIBLE when it is placed in the hand.
The serial number and other markings shall be legible utilizing an
optical aid if necessary.
If the size of the HEARING INSTRUMENT AID does not allow affixation of all
required markings, the markings shall be recorded in full in the
ACCOMPANYING DOCUMENTS or instructions for use (IFU).
Tests:
Inspection and verification of the applicable requirements.
201.7.2.2 Markings Requirements:
7.3.3 HEARING INSTRUMENTS AIDS shall be marked with:
– the name or trademark of the MANUFACTURER;
7.4.2
– a MODEL OR TYPE REFERENCE.
7.8.2
HEARING INSTRUMENTS AIDS shall be marked visibly on the outside or
inside when the battery drawer is open at a user accessible location
(e.g. battery drawer), with:
– if needed: identification of right and left HEARING INSTRUMENT AID.
Right = red. Left = blue;
– serial number.
HEARING INSTRUMENTS AIDS worn in the ear: The marking on the
instrument HEARING AID may be reduced to the serial number and the
identification of right and left.
The type of battery and the mode of insertion shall be marked on
HEARING INSTRUMENTS AIDS unless the design of the battery
compartment prevents incorrect replacement of a battery
Different positions of control devices and switches shall be indicated by
figures, letters or other visual means.
RISK, such controls
If the change of setting of a control could result in a
shall be provided with an indicating device or an indication of the
direction in which the magnitude of the function changes.
The color red shall be used only for emergency controls.
Tests:
Inspection and verification of the applicable requirements.

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Reference Subject Requirements and tests
201.7.2.17 Protective Requirements:
packaging
If special handling measures have to be taken during transport or
storage, the packaging shall be marked accordingly.
Tests:
Inspection and verification of the applicable requirements.
201.7.8.1 ACCOMPANYING Requirements:
DOCUMENTS
201.7.9 HEARING INSTRUMENTS AIDS shall be accompanied by instructions
containing at least:
7.6.1
– the purpose and INTENDED USE of the HEARING INSTRUMENT AID;
– instructions for use, operating functions and a technical description;
– easily understood diagrams, illustrations, or photographs of the
fully assembled and ready-to-operate HEARING INSTRUMENT AID
including all controls, visual information signals, and indicators,
proper connection of the PATIENT to the HEARING INSTRUMENT AID,
ACCESSORIES and other equipment;
– identification of the HEARING INSTRUMENT AID:
• name or trade name of the MANUFACTURER and an address to
which the PATIENT can refer;
• MODEL OR TYPE REFERENCE;
– a list of detachable and replaceable parts as well as ACCESSORIES;
– any restrictions on locations or environments in which the HEARING
INSTRUMENT AID can be used;
– identification of any known side effects associated with the use of
HEARING INSTRUMENT AID that may warrant consultation with a
physician e.g. accumulation of cerumen;
– advice to the PATIENT to contact the MANUFACTURER or the
MANUFACTURER's representative:
• for assistance, if needed, in setting up, using or maintaining
the HEARING INSTRUMENT AID or HEARING INSTRUMENTS AID
SYSTEM;
• to report unexpected operation or events;
– a description and illustration on how to replace and/or recharge
batteries;
– colors of indicator lights and their meanings;
– the meanings of the symbols used for marking (symbols see 7.6.2).
– how to dispose of batteries of the HEARING INSTRUMENTS AIDS and of
any part that may provide a RISK associated with the disposal;
– information about cleaning and maintenance, where applicable:
• the procedure to follow for washing the ear mould;
• replacing tubing, filters and other replaceable parts;
• storing the HEARING INSTRUMENT AID;
• special adequate maintenance for rechargeable batteries;
• information on how and where to obtain repair service;
– if a HEARING INSTRUMENTS AIDS is difficult to retrieve from the ear
canal a method to detect its location and to retrieve it shall be
provided;
– warning and safety notices in a specifically identified section of the
instructions for use; if a warning or safety notice applies only to a
specific instruction or action it should precede the instruction to
which it applies;
• for HEARING INSTRUMENTS AIDS in pediatric applications:
Warning to keep small parts (HEARING INSTRUMENTS AIDS,
batteries and detachable parts) that can be swallowed out of
children’s reach;
• for HEARING INSTRUMENTS able to provide more than 132 dB
SPL: warning to the professional OPERATOR fitting the HEARING
INSTRUMENT that there may be a RISK of impairing the
remaining hearing of the PATIENT;
• for HEARING INSTRUMENTS AIDS that do not comply with
requirements for explosive or oxygen-enriched atmospheres:
warning not to use the HEARING INSTRUMENTS AIDS in such
areas where there is danger of explosion;

Reference Subject Requirements and tests
• warning that the specific HEARING INSTRUMENT must AID shall
only be used by the intended person and not by others;
• for HEARING INSTRUMENTS AIDS with wireless transmission:
warning to check first before using the HEARING AID SYSTEM in
areas where electronics or wireless devices are restricted;
• statement required about the special needs of particular
PATIENT groups e.g. small children or mentally disabled
persons;
• warning about common conditions that could damage the
HEARING INSTRUMENT AID such as dropping, immersing in liquid,
strong electromagnetic fields or excessive heat;
• other warnings that may result from the risk assessment, e.g. a
warning if parts could remain in the ear and what to do;
• the permissible environmental conditions of transport and
storage of a HEARING AID after it has been removed from its
protective packaging and subsequently between uses;
• for each warning and safety sign, the nature of the HAZARD,
likely consequences that could occur if the advice is not
followed, and the precautions for reducing the RISK;
• if leakage from a battery would result in a RISK, a warning to
remove the battery;
• if the HEARING INSTRUMENT AID can be externally connected, a
warning only to connect to equipment that conforms to relevant
international safety standards;
– permissible environmental conditions of transport and storage of a
HEARING INSTRUMENT AID after it has been removed from its
protective packaging and subsequently between uses;
– the ACCOMPANYING DOCUMENTS shall be written at a level consistent
with the education, training and any special needs of the person(s)
for whom they are intended;
– the instructions for use shall be in a language that is acceptable to
the intended PATIENT;
– Warning to the HEARING AID PROFESSIONAL;
• for HEARING AIDS able to provide more than 132 dB SPL:
warning to the professional OPERATOR fitting the HEARING AID
that there may be a RISK of impairing the remaining hearing of
the PATIENT;
• the developed SPL in the ears of children can be substantially
higher than in average adults. RECD measured to correct
target of fitted OSPL90 is recommended;
Parts of the ACCOMPANYING DOCUMENTS may be provided electronically.
If so, the RISK MANAGEMENT PROCESS shall include consideration of
which information also needs to be provided as hard copy.
Tests:
Inspection and verification of the applicable requirements.
201.8 Protection Requirements:
against
201.8.7 HEARING INSTRUMENTS AIDS that are normally used in a HOME
electrical
HEALTHCARE ENVIRONMENT with connections to electrical equipment in
HAZARDS
201.5.7
compliance with the relevant standard IEC 60065, IEC 60950-1,
IEC 62368-1 or other applicable IEC safety standards shall pass the
PATIENT LEAKAGE CURRENT requirements of 100 µA RMS at 275 V AC, as
described in 201.8.7.
Tests:
PATIENT LEAKAGE CURRENT of 201.8.7, measurement after the humidity
treatment of 201.5.7 and the drop test of 201.15.3.4.

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Reference Subject Requirements and tests
201.16 ACCESSIBLE Requirements:
PARTS
201.5.9.2.1 The voltage to earth or to ACCESSIBLE PARTS other than HEARING
INSTRUMENTS AIDS shall not exceed 42,4 V peak AC or 60 V DC in
NORMAL CONDITION or in SINGLE FAULT CONDITION. The DC limit of 60 V
applies to DC with not more than 10 % peak-to-peak ripple. If the ripple
exceeds that amount, the 42,4 V peak limit applies. The energy power
shall not exceed 240 VA for longer than 60 s or the stored energy
available shall not exceed 20 J at a potential up of to 2 V or more.
Tests:
Inspection of product documentation in case this inspection is not
conclusive: measurement.
If internal parts exceed these limits, access is tested by test finger
(201.5.9.2.1); small finger probe (Figure 1of IEC 60601-1-11:2010.),
test pin (Figure 8 of IEC 60601-1:2005) and/or metal test rod (8.4.2).
201.8.4.2 Accessible Requirements:
contacts
201.8.7.4.8 If an internally supplied HEARING INSTRUMENTS AIDS rated at 1,6 4,5 V
DC or less has ACCESSIBLE PARTS, the DC current flowing in a realistic
worst-case configuration between those contacts shall not exceed 10
µA and the RISK ASSESSMENT shall cover the particular design and
application.
Tests:
Measurement and inspection of the RISK ASSESSMENT
201.9 Mechanical Requirements:
hazards
Rough surfaces, sharp corners and edges of HEARING INSTRUMENT AID
and HEARING INSTRUMENT AID SYSTEMS (e.g. moulded edges, battery
doors and connector flanges) that could cause injury of damage shall
be avoided or covered.
Test: inspection of the HEARING INSTRUMENT AID, HEARING INSTRUMENT
AID SYSTEMS and the RISK MANAGEMENT FILE.
201.9.6 Acoustic energy Requirements:
201.13 HEARING INSTRUMENTS AIDS shall be designed in a way that users cannot
be unintentionally exposed to a sound pressure level above 132 dB in
IEC 60118-7:2005
NORMAL and SINGLE FAULT CONDITION SPL above the fitted OSPL90 in
NORMAL CONDITION.
IEC 60118-0
The acceptable level increase in SINGLE FAULT condition, which shall be
evaluated in the RISK MANAGEMENT FILE.

The fitted OSPL90 shall be indicated on either the HEARING AID or the
fitting software or otherwise. The maximum deviation shall be evaluated
in the RISK MANAGEMENT FILE.
HEARING AIDS with a possible MAXIMUM OUTPUT SOUND PRESSURE LEVEL of
132 dB SPL require a special warning notice for the HEARING AID
PROFESSIONAL (see 201.7).
Tests:
Inspection of circuitry, firmware and software as applicable. Test in
normal use and under SINGLE FAULT CONDITION.
Measurements of sound pressure level are described in IEC 60118-
7:2005
Inspection of the RISK MANAGEMENT FILE
201.9.101 Entanglement Requirements:
Cables and lanyards of HEARING INSTRUMENTS AIDS or ACCESSORIES
worn by the PATIENT around the neck shall not pose a RISK of injury or
strangulation. The disconnection force shall be no greater than 30 N.
Tests:
Application of the pull force.

Reference Subject Requirements and tests
201.9.102 Parts remaining Requirements:
in the ear canal
A HEARING INSTRUMENT AID that can be worn in the ear canal shall be
safely retrievable by the PATIENT.
HEARING INSTRUMENTS AIDS shall be designed in a way that parts do not
come loose during use, insertion and retrieval from the ear canal.
Any part which is exposed to a pull force during the removal of a
HEARING INSTRUMENT AID from the ear canal shall resist a force of at
least 3 N without coming loose from the instrument HEARING AID.
Tests:
Application of the pull force test, inspection of user instructions.
201.10 LED Requirements:
10.4 LEDs shall be class I according to IEC 60825-1.
Tests:
Inspection of the component specification and the circuitry.
201.11 Maximum Requirements:
temperature
201.13 Maximum temperature of the HEARING INSTRUMENTS AIDS shall not
exceed 41 °C in normal use (in case of higher temperature, see
201.11.1.1) and 50 48 °C under fault conditions. If the hearing aid can
operate in ambient temperatures above 43 °C, the maximum case
temperature is permitted to be equal to the ambient temperature.
Tests:
Inspection of energy source and circuitry causing self-heating of the
hearing aid. In case of doubt, a measurement shall be performed: the
maximum temperature of the HEARING AID shall not exceed 43 °C, when
tested in ambient temperature of 25 °C to 35 °C.
201.11.6.5 Ingress of water Requirements: If the RISK ASSESSMENT requires protection against
harmful ingress of water or particulate matter, the IP class of the
HEARING INSTRUMENT AID shall be not less than the level required for
safe operation as detailed in IEC 60529.
Tests:
Apply IEC 60529.
201.11.6.6 Cleaning Requirements:
HEARING INSTRUMENTS AIDS and HEARING INSTRUMENT AID SYSTEMS and
their parts and ACCESSORIES shall be capable of withstanding, without
damage or deterioration, the cleaning or disinfection processes (such
as cerumen removal), as specified in the instructions for use.
Tests:
Evaluate the effects of multiple cleanings during the EXPECTED SERVICE
LIFE of the HEARING INSTRUMENTS AIDS and HEARING INSTRUMENTS AID
SYSTEMS, their parts and ACCESSORIES and assure that no unacceptable
RISK will occur. The results of the evaluation shall be documented in the
RISK MANAGEMENT FILE.
11.6.8 Compatibility Requirements:
with substances
When applicable, the MANUFACTURER shall address in the RISK
MANAGEMENT PROCESS the RISKS associated with compatibility with
substances used with the HEARING INSTRUMENT AID.
Tests:
Inspection of the RISK MANAGEMENT FILE.
11.7 Biocompatibility Requirements:
HEARING INSTRUMENTS AIDS shall be biocompatible.
Tests:
Assessment and documentation according to the guidance and
principles given in ISO 10993 series (all parts).

– 14 – IEC TR 62809:2019 RLV © IEC 2019
Reference Subject Requirements and tests
201.7.1.1 Usability Requirements:
201.12.2 USABILITY ENGINEERING PROCESS according to IEC 60601-1-6 and IEC
62366 shall be performed. The results have to be considered in the
12.2
design of a product, the labelling and instructions.
IEC 60601-1-6
HEARING INSTRUMENTS AIDS should be designed to be simple to use and
not require reference to complex instructions.
Typical PRIMARY OPERATING FUNCTIONS are:
– critical functions:
• placing and removing the HEARING INSTRUMENT AID;
• fitting a HEARING INSTRUMENT AID;
• testing of essential physical HEARING INSTRUMENT AID
parameters;
– frequently used functions:
• changing battery;
• cleaning;
• switching on /off;
• adjust volume, program and other essential parameters.
Tests:
Inspection of the results of the USABILITY ENGINEERING PROCESS and the
instructions; trial test the product if necessary.
201.12.4.4 Incorrect output Requirements:
When a control adjusts the intended maximum power output, output
power shall not increase if the control is disconnected or defective.
Software controlled maximum power settings shall not exceed the
selected value as a result of corrupt data transfer between programmer
and HEARING INSTRUMENT AID.
Tests:
Inspection of circuitry, firmware, software and the RISK MANAGEMENT
FILE; trial test where necessary.
12.4.3 Incorrect output Requirements:
The MANUFACTURER shall address in the RISK MANAGEMENT
PROCESS the RISKS associated with accidental selection of an
excessive output value.
Tests:
Inspection of the RISK MANAGEMENT FILE.

Reference Subject Requirements and tests
201.13 HAZARDOUS Requirements:
SITUATIONS and
13 The following HAZARDOUS SITUATIONS shall not occur:
fault conditions
– emission of flames, molten metal, poisonous or ignitable substance
11.3
in hazardous quantities;
– deformation of ENCLOSURES to such an extent that risks result;
– temperatures of HEARING INSTRUMENTS AIDS that are likely to be
touched, exceeding 50 °C when measured and adjusted as
described in 201.11.1.3 of the general standard shall not exceed
43 °C.
- exceeding the allowable values for “other components and
materials” identified in Table 22 of the general standard times 1,5
minus 12,5 °C.
Tests:
Inspection of circuit, application of faults.
Faults need not be applied if
a) the construction or the supply circuit limits the power dissipation in
SINGLE FAULT CONDITION to less than 15 W or the energy dissipation
to less than 900 J,
or
b) if parts are completely contained within a fire enclosure according
to the general standard.
See 201.13.2.1 for the description of SINGLE FAULT and NORMAL
CONDITIONS.
NOTE The requirements to HEARING INSTRUMENTS AIDS that are intended
to be used in oxygen enriched or explosive atmospheres are not
contained in this particular standard IEC 60601-2-66.

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Reference Subject Requirements and tests
201.14 Software Requirements:
– Embedded and fitting software shall conform to IEC 62304.
– The classification of software according to IEC 62304 shall be the
result of the RISK ASSESSMENT.
Aspects to be considered beyond the requirements of IEC 62304:
14.2 Documentation
The required processes for RISK MANAGEMENT and software
development have to shall be correctly implemented and maintained.
Documentation that the PROCESS steps have been performed needs to
be filed in the RISK MANAGEMENT FILE.
A document control system needs to be in place.
14.3 RISK MANAGEMENT plan
In addition to elements of the RISK MANAGEMENT plan required by
ISO 14971, a PEMS VALIDATION plan is required.
14.6.1 Identification of known and foreseeable HAZARDS
PEMS have extra initiating causes for HAZARDS.
14.11 PEMS VALIDATION
PEMS VALIDATION is intended to assure that the right product is built.
Unexpected interactions between functions might occur that can only be
discovered by validation. It can include tests for a high volume of data,
heavy loads or stresses, human factors, security, performance,
configuration compatibility, fault testing, documentation and safety.
Independence is needed to avoid conflicts of interest and because the
assumptions of the designer should not influence or limit the extent of
the PEMS VALIDATION. Examples of level of independence include:
– separate person;
– separate management;
– separate organization.
Tests:
Application of the requirements in Clause 201.14.2 to 201.14.13
(inclusive), by inspection of the RISK MANAGEMENT FILE. Compliance with
the IEC 62304 software design and the RISK MANAGEMENT PROCESS by
inspection of external or internal audit reports or certificates.
201.15.2 Serviceability Requirements:
HEARING INSTRUMENTS AIDS subject to mechanical wear,
Parts of
electrical and environmental degradation or ageing that could result in
an unacceptable RISK if allowed to continue unchecked for too long a
period shall be accessible for inspection, replacement and
maintenance.
Tests:
Inspection of such parts and their location.

Reference Subject Requirements and tests
201.15.3 Mechanical Requirements:
strength
HEARING INSTRUMENTS AIDS or its parts shall have adequate mechanical
strength and shall not result in an unacceptable RISK due to moulding
stress or when subjected to mechanical stress caused by pushing,
impact, dropping, and rough handling.
Mechanical design requirements for instruments HEARING AIDS intended
for use by infants under 36 months:
a) battery doors shall be constructed to:
• require a TOOL to remove the battery, or
• require a force of at least 10 N in the least favorable direction
to remove the battery,
b) any detachable part of the HEARING INSTRUMENT AID (e.g. ear hook,
tube, type plate, programming cover) shall not be removable:
• without a TOOL, or
• with a force lower than 10 N in the direction of least resistance.
Tests:
Inspection of the product and the application of the described forces.
201.15.3.4 Drop test Requirement:
HEARING INSTRUMENTS AIDS shall not result in an unacceptable RISK as a
result of a free fall, such as increased LEAKAGE CURRENT or mechanical
hazards.
Test:
The sample to be tested is allowed to fall freely once from each of six
different starting orientations from 1,5 1,0 m height onto a hard wood
surface.
201.15.3.7 Environmental Requirements:
influences
The selection and treatment of materials used in the construction of
HEARING INSTRUMENTS AIDS shall take account of the INTENDED USE, the
EXPECTED SERVICE LIFE and the conditions for transport and storage.
The HEARING INSTRUMENTS AIDS shall be so designed and constructed
that during its EXPECTED SERVICE LIFE any corrosion, ageing, mechanical
wear, or degradation of biological materials due to the influence of
moisture, sweat, humidity, hair care products or toiletries shall not
reduce its mechanical properties in a way that results in an
unacceptable RISK.
Tests:
Inspection of HEARING INSTRUMENTS AIDS, the ACCOMPANYING
DOCUMENTS and of the specifications of materials used, of the
processing specifications for these materials and relevant tests or
calculations.
201.15.4.3.1 Housing Requirements:
Battery compartments shall be designed to prevent accidental short
circuiting of the battery where such short circuits could result in a
HAZARDOUS SITUATION.
HAZARDOUS SITUATION might develop by the incorrect connection or
If a
replacement of a battery, the equipment shall be fitted with a means of
preventing incorrect polarity.
Tests:
Inspection of circuit and construction.
15.4.3.3 Overcharging Requirements:
Where overcharging of any battery could result in an unacceptable RISK,
the design shall prevent overcharging.
Tests:
Inspection of the design documentation.

– 18 – IEC TR 62809:2019 RLV © IEC 2019
Reference Subject Requirements and tests
201.15.4.3.101 Batteries Requirements:
Batteries, used to supply HEARING INSTRUMENTS AIDS, shall comply with
the relevant international standards. The design of the electronic circuit
shall avoid overheating of a wrongly inserted battery above 50 °C.
Tests:
Inspection of circuit and construction, if necessary, testing. Inspection
of the instructions for use.
201.17 Electromagnetic Requirements:
compatibility
The MANUFACTURER shall address in the RISK MANAGEMENT PROCESS the
RISKS associated with the introduction by the HEARING INSTRUMENT AID
of electromagnetic phenomena into the environment that might degrade
the performance of other devices, electrical equipment and systems.
Tests:
Electromagnetic compatibility is tested according to IEC 60118-13. If
the HEARING INSTRUMENT has a wireless transmitter, emissions are
furthermore tested according to relevant international radio standards.
Electromagnetic compatibility shall be tested in accordance with
IEC 60601-1-2. For HEARING AIDS, additional testing for immunity to
digital wireless interference shall be tested according to IEC 60118-13.
Pass/fail criteria shall be defined according to the generic standard
IEC 60601-1-2.
Inspection of the RISK MANAGEMENT FILE.

Bibliography
IEC 60065:20012014, Audio, video and similar electronic apparatus – Safety requirements
IEC 60118-7:2005, Electroacoustics – Hearing aids – Part 7: Measurement of the performance
characteristics of hearing aids for production, supply and delivery quality assurance purposes
IEC 60118-0:2015, Electroacoustics – Hearing aids – Part 0: Measurement of the performance
characteristics of hearing aids
IEC 60118-13:20112016, Electroacoustics – Hearing aids – Part 13: Electromagnetic
compatibility (EMC)
IEC 60529, Degrees of protection provided by enclosures (IP Code)
IEC 60601 (all parts), Medical electrical equipment
IEC 60601-1-1:2000, Medical electrical equipment – Part 1-1: General requirements for safety
– Collateral standard: Safety requirements for medical electrical systems
IEC 60601-1-2, Medical electrical equipment – Part 1-2: General requirements for basic safety
and essential performance – Collateral Standard: Electromag
...