IEC 60601-2-66:2019

IEC 60601-2-66 ®
Edition 3.0 2019-10
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-66: Particular requirements for the basic safety and essential
performance of hearing instruments aids and hearing instrument aids systems

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
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and withdrawn publications.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 60601-2-66 ®
Edition 3.0 2019-10
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –

Part 2-66: Particular requirements for the basic safety and essential

performance of hearing instruments aids and hearing instrument aids systems

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.180.15; 17.140.50 ISBN 978-2-8322-7543-6

– 2 – IEC 60601-2-66:2019 RLV © IEC 2019
CONTENTS
FOREWORD . 4
INTRODUCTION . 2
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions . 11
201.4 General requirements . 13
201.5 General requirements for testing ME EQUIPMENT . 14
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 15
201.7 ME EQUIPMENT identification, marking and documents . 16
201.8 * Protection against electrical HAZARDS from ME EQUIPMENT . 21
201.9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 24
201.10 * Protection against unwanted and excessive radiation HAZARDS . 26
201.11 * Protection against excessive temperatures and other HAZARDS . 26
201.12 * Accuracy of controls and instruments and protection against hazardous
outputs. 28
201.13 * HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 29
201.14 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 32
201.15 * Construction of ME EQUIPMENT . 32
201.16 * ME SYSTEMS . 34
201.17 * Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 35
Annexes . 36
Annex E (informative) Examples of the connection of the measuring device (MD) for
measurement of the PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT . 37
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 38
Annex H (informative) PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE and
documentation . 39
Annex I (informative) ME SYSTEMS aspects . 40
Annex J (informative) Survey of insulation paths . 41
Annex K (informative) Simplified PATIENT LEAKAGE CURRENT diagrams . 42
Annex L (normative) Insulated winding wires for use without interleaved insulation . 43
Annex AA (informative) Particular guidance and rationale . 44
Annex BB (informative) Abbreviations . 50
Annex CC (informative) Essential performance . 51
Annex DD (informative) Electromagnetic compatibility of ME EQUIPMENT . 52
Bibliography . 54
Index of defined terms used in this particular standard . 56

Figure 201.101 – Measuring circuit for LEAKAGE CURRENT (see 201.8.7.4.7) . 23

Table 201.101 – MECHANICAL HAZARDS to be considered . 25
Table AA.101 – Summary of the approach of this document . 45

Table DD.101 – Example of applicable standards for HEARING AID specific setting for
RF radiated emissions . 52
Table DD.102 – Example of applicable tests . 53

– 4 – IEC 60601-2-66:2019 RLV © IEC 2019
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-66: Particular requirements for the basic safety and essential
performance of hearing instruments aids
and hearing instrument aid systems

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC Publication(s)"). Their
preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
may participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
rights. IEC shall not be held responsible for identifying any or all such patent rights.
This redline version of the official IEC Standard allows the user to identify the changes
made to the previous edition. A vertical bar appears in the margin wherever a change has
been made. Additions are in green text, deletions are in strikethrough red text.

International Standard IEC 60601-2-66 has been prepared by IEC technical committee 29:
Electroacoustics.
This third edition cancels and replaces the second edition published in 2015. It constitutes a
technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) revision of the definition about ESSENTIAL PERFORMANCE;
b) revision of the application of IEC 60601-1-2:2014 for electromagnetic disturbances;
c) correction of the used voltage for HEARING AIDS from 1,6 V to 4,5 V;
d) correction of the drop test level from 1,5 m to 1,0 m;
e) correction of the wording of IEC 60601-2-66:2015.
The text of this International Standard is based on the following documents:
FDIS Report on voting
29/1023/FDIS 29/1030/RVD
Full information on the voting for the approval of this International Standard can be found in the
report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document, the following print types are used:
– requirements and definitions: roman type;
– test specifications: italic type;
– informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type;
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term
– "clause" means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this document are preceded by the term "Clause" followed by the
clause number. References to subclauses within this particular standard are by number only.
In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in Clause 7 of the ISO/IEC
Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance with
this document;
– "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;

– 6 – IEC 60601-2-66:2019 RLV © IEC 2019
– "may" is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC publication in
which to make products in accordance with the new requirements and to equip themselves for conducting new or
revised tests. It is the recommendation of the committee that the content of this publication be adopted for
implementation nationally not earlier than 3 years from the date of publication.

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
In 1998, the HEARING INSTRUMENT AID industry represented by the European hearing instrument
manufacturers association (EHIMA) attempted to establish a standard with the main purpose of
providing MANUFACTURERS with a guide to demonstrate conformity with the European Medical
Devices Directive 93/42/EEC.
The draft document prEN 50220 failed CENELEC vote and was published as "EHIMA standard"
in June 1998 with almost identical content. EHIMA concluded in 2009 that the requirements of
that standard were no longer up to date and an internationally accepted standard for HEARING
INSTRUMENT AID safety published by IEC or ISO to demonstrate compliance with regulatory
requirements should be produced.
This resulting IEC standard amends and supplements IEC 60601-1 (third edition, 2005):
Medical electrical equipment – Part 1: General requirements for safety and essential
performance, hereinafter referred to as ‘the general standard’.
Figures in square brackets refer to the Bibliography.
This particular standard amends and supplements IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012, hereinafter referred to as the "general standard".
A general guidance and rationale for the requirements of this particular standard are given in
Annex AA. It is considered that knowledge of the reasons for these requirements will not only
facilitate the proper application of this particular standard but will, in due course, expedite any
revision necessitated by changes in clinical practice or as a result of developments in
technology. However, Annex AA does not form part of the requirements of this document.

– 8 – IEC 60601-2-66:2019 RLV © IEC 2019
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-66: Particular requirements for the basic safety and essential
performance of hearing instruments aids
and hearing instrument aid systems

201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This part of IEC 60601 applies to the BASIC SAFETY of HEARING INSTRUMENTS AIDS and HEARING
INSTRUMENT AID SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM.
If a clause or subclause is specifically intended to be applicable to HEARING INSTRUMENTS AIDS
only, or to HEARING INSTRUMENT AID SYSTEMS only, the title and content of that clause or
subclause will say so. If that is not the case, the clause or subclause applies both to HEARING
INSTRUMENTS AIDS and to HEARING INSTRUMENT AID SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of HEARING INSTRUMENTS AIDS or HEARING
INSTRUMENT AID SYSTEMS within the scope of this document are not covered by specific
requirements in this document except in 201.7.9.2 and 201.9.6.
NOTE See also 201.4.2. (RISK MANAGEMENT) 4.2 of the general standard.
ACCESSORIES to HEARING INSTRUMENTS AIDS in the HOME HEALTHCARE ENVIRONMENT (e.g. remote
control units, audio streamers, battery chargers, power supplies) are covered by the most can
be tested according to the applicable standard, IEC 60065, IEC 60950-1, IEC 62368-1 or other
applicable IEC safety standards. Alternatively, the general standard may be applied. HEARING
INSTRUMENTS AIDS do not have a MAINS PART intended for connection to AC SUPPLY MAINS. The
connection to the SUPPLY MAINS of a HEARING INSTRUMENT AID SYSTEM is covered by power supply,
charger or other types of ACCESSORIES.
ACCESSORIES connected to a HEARING INSTRUMENT may form a HEARING INSTRUMENT SYSTEM.
Only the HEARING INSTRUMENT and its detachable parts are subject to all applicable clauses of
this particular standard. The remaining components of the HEARING INSTRUMENT SYSTEM are
subject to requirements of this particular standard that result from their connection to the
HEARING INSTRUMENT SYSTEM.
Programming interfaces or ACCESSORIES in a clinical application are covered by the general
standard.
ACCESSORIES with FUNCTIONAL CONNECTION to a HEARING AID may form a HEARING AID SYSTEM.
HEARING AID related ACCESSORIES that are not physically connected to the HEARING AID during
NORMAL USE are not considered to be APPLIED PART, because they do not directly contribute to
the INTENDED USE of the HEARING AID.
___________
The general standard is IEC 60601-1 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment – Part 1:
General requirements for basic safety and essential performance.

Wireless programming interfaces are covered by the applicable standard IEC 60065,
IEC 60950-1, IEC 62368-1 or other applicable IEC safety standards. Alternatively, the general
standard may be applied.
Programming interfaces with wired connection to the HEARING AID are covered by the general
standard.
NOTE Detachable parts of HEARING INSTRUMENTS AIDS, even if supplied separately (e.g. ear hooks, domes, wax
guards etc.), are not regarded considered as ACCESSORIES, but as component parts.
This document does not apply to:
– cochlear implants or other implanted HEARING INSTRUMENTS AIDS;
– bone conduction HEARING INSTRUMENTSAIDS;
– educational HEARING INSTRUMENTSAIDS (i.e. group HEARING INSTRUMENTSAIDS, auditory
trainers etc.);
– the application of a HEARING INSTRUMENTAID for the measurement of hearing levels.;
IEC 60645-1 applies;
– fix installed audio-frequency induction-loop systems or their component parts, as described
in IEC 60118-4 and IEC 62489-1;
– assisted HEARING INSTRUMENT SYSTEMS using infra-red or radio;
– the sound generating function of a tinnitus masker.
This document does not address applicable testing for intentional RF radiation of wireless
equipment (e.g. maximum radiated output power, modulation bandwidth, etc.).
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY requirements for
HEARING INSTRUMENTS AIDS and HEARING INSTRUMENT AID SYSTEMS as defined in 201.3.202 and
201.3.203.
201.1.3 * Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-9 and IEC 60601-1-10 and IEC 60601-1-11 do not
apply. All other published collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.

– 10 – IEC 60601-2-66:2019 RLV © IEC 2019
For brevity, IEC 60601-1 and IEC 60601-1:2005/AMD1:2012 is referred to in this particular
standard as the general standard. Collateral standards are referred to by their document
number.
The numbering of clauses and subclauses of this particular standard corresponds to that of the
general standard with the prefix "201" (e.g. 201.1 in this document addresses the content of
Clause 1 of the general standard) or applicable collateral standard with the prefix "20x" where
x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular
standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral standard, 203.4 in
this particular standard addresses the content of Clause 4 of the IEC 60601-1-3 collateral
standard, etc.). The changes to the text of the general standard are specified by the use of the
following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of the
general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.139 3.147, additional definitions in this document are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where "x" is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this document" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general standard
or applicable collateral standard, although possibly relevant, is not to be applied, a statement
to that effect is given in this particular standard.
201.2 Normative references
NOTE Informative references are listed in the Bibliography.
Clause 2 of the general standard applies except as follows:
Replacement:
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral Standard: Electromagnetic disturbances –
Requirements and tests
IEC 60950-1:2005, Information technology equipment – Safety – Part 1: General requirements
IEC 60950-1:2005/AMD1:2009
IEC 60950-1:2005/AMD2:2013
Addition:
IEC 60118-0:2015, Electroacoustics – Hearing aids – Part 0: Measurement of electroacoustical
the performance characteristics of hearing aids
IEC 60118-13, Electroacoustics – Hearing aids – Part 13: Electromagnetic compatibility (EMC)
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1-11:2015, Medical electrical equipment – Part 1-11: General requirements for basic
safety and essential performance – Collateral Standard: Requirements for medical electrical
equipment and medical electrical systems used in the home healthcare environment
IEC 62304, Medical device software – Software life cycle processes
IEC 62366:2007, Medical devices – Application of usability engineering to medical devices
IEC 62368-1:2018, Audio/video, information and communication technology equipment –
Part 1: Safety requirements
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012 and the following apply, except as follows.
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
NOTE An index of defined terms is found beginning on page 56.
201.3.73
OPERATOR
Addition:
Note 101 to entry Usually equals to PATIENT for HEARING instruments AIDS in a home healthcare environment.
201.3.76
PATIENT
Addition
Replacement:
Note 1 to entry: In this particular standard and in applying the requirements of the general standard, the term
PATIENT has the meaning explained in the second paragraph of 4.1 of the general standard. The PATIENT is also
usually the OPERATOR.
The term PATIENT is being used in this document in line with the general terminology in the medical product field. It
is, however, understood that the user of a HEARING INSTRUMENT AIDS is typically not an ill person but someone healthy
with a hearing impairment in a HOME HEALTHCARE ENVIRONMENT.

– 12 – IEC 60601-2-66:2019 RLV © IEC 2019
201.3.113
SERVICE PERSONNEL
Replacement:
individuals or entity that assemble, maintain or repair HEARING INSTRUMENTS AIDS or HEARING
INSTRUMENT AID SYSTEMS
201.3.132
TYPE B APPLIED PART
Replacement:
APPLIED PART complying with the specified requirements of this particular standard to provide
protection against electric shock, particularly regarding allowable PATIENT LEAKAGE CURRENT and
PATIENT AUXILIARY CURRENT
Addition:
201.3.201
HEARING HEALTH-CARE PROFESSIONAL
acoustician, audiologist and trained clinical staff
HEARING AID PROFESSIONAL
audiologically competent person who professionally assesses hearing, selects, fits and delivers
HEARING AID systems and rehabilitation services to persons with hearing impairment
201.3.202
HEARING INSTRUMENT
HEARING AID
ME EQUIPMENT which picks up sound and delivers processed sound to the ear canal through air-
conduction
Note 1 to entry: A HEARING INSTRUMENT AID includes all detachable parts that are essential for the performance of
its INTENDED USE.
201.3.203
HEARING SYSTEM
HEARING INSTRUMENT AID SYSTEM
combination, as specified by its MANUFACTURER, of items of equipment, at least one of which is
a HEARING INSTRUMENT AID to be inter-connected by specified FUNCTIONAL CONNECTIONS
201.3.204
SOUND PRESSURE LEVEL
SPL
L
p
ten times the logarithm to the base 10 of the ratio of the root-mean-square of the sound pressure
in the time domain, p, to the square of a the reference value, p , expressed in decibels
p
L = 10lg dB
p
p
where the reference value, p , is 20 µPa
Note 1 to entry: Because of practical limitations of the measuring instruments, p is always understood to denote
the square of a frequency-weighted, frequency-band-limited or time-weighted sound pressure.
If specific frequency and time weightings as specified in IEC 61672-1 and/or specific frequency bands are applied,
this should be indicated by appropriate subscripts; e.g. L denotes the A-weighted SOUND PRESSURE LEVEL with
p,AF
time weighting F.
Note 2 to entry: This definition is technically in accordance with ISO/FDIS 80000-8:20072019, 8-22.
Note 3 to entry: The note to entry concerning the origin of the English abbreviation “SPL” concerns the French text
only. This note applies to the French language only.
Note 4 to entry: Any SOUND PRESSURE LEVEL specified in this document is measured in decibels (dB) as described
in IEC 60118-0 by using a coupler according to IEC 60318-5.
[SOURCE: ISO/TR 25417:2007, 2.2. modified – The abbreviated term "SPL" has been added,
as well as Notes 3 and 4 to entry.]
201.3.205
MAXIMUM OUTPUT SOUND PRESSURE LEVEL
MAXIMUM OSPL90
maximum output SPL of the HEARING AID when measured with full-on setting and 90 dB input
SPL, as defined in IEC 60118-0
201.3.206
FITTED MAXIMUM OUTPUT SOUND PRESSURE LEVEL
FITTED OSPL90
maximum output SPL of a HEARING AID when measured after fitting and 90 dB input SPL
Note 1 to entry: Since the HEARING AID parameters are not full-on, the FITTED OSPL90 is equal or lower than the
MAXIMUM OSPL90. Usually, the FITTED OSPL90 is achieved by selection of a HEARING AID with an appropriate MAXIMUM
OSPL90 and fine tuning of the maximum output.
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS
Replacement:
Unless otherwise specified, the requirements of this document shall apply in NORMAL USE and
reasonably foreseeable misuse.
When applying this document to HEARING INSTRUMENTS AID or HEARING INSTRUMENT AID SYSTEMS,
the definitions and requirements that use the term PATIENT shall be considered as applying to
the person for whom the HEARING INSTRUMENT AID or HEARING INSTRUMENT AID SYSTEMS is
intended.
201.4.3 *ESSENTIAL PERFORMANCE
Replacement:
HEARING INSTRUMENTS do not have an ESSENTIAL PERFORMANCE.
Addition:
See Annex CC.
201.4.6 ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT
Subclause 4.6 of the general standard does not apply.
201.4.10 Power supply
Subclause 4.10 of the general standard does not apply.

– 14 – IEC 60601-2-66:2019 RLV © IEC 2019
201.4.11 Power input
Subclause 4.11 of the general standard does not apply.
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.2 Number of samples
Replacement:
TYPE TESTS are performed on a representative sample of the item being tested. If multiple
products are under consideration, which have a similar mechanical and electrical architecture,
then an engineering analysis by the MANUFACTURER may justify a single representative sample
for a family of products.
201.5.3 Ambient temperature, humidity, atmospheric pressure
Replacement:
After the HEARING INSTRUMENT AID or HEARING INSTRUMENT AID SYSTEM to be tested has been set
up for NORMAL USE, tests are performed within the range of environmental conditions indicated
in the technical description, as specified by the MANUFACTURER.
201.5.4 Other conditions
Addition:
aa) Inventory stocking conditions are specified by the MANUFACTURER.
bb) HEARING INSTRUMENT AID transport conditions are specified by the MANUFACTURER.
201.5.5 Supply voltages, type of current, nature of supply, frequency
Replacement:
a) Where test results are influenced by deviations of the supply voltage from its rated value,
the effect of such deviations shall be taken into account.
b) HEARING INSTRUMENTS AID and HEARING INSTRUMENT AID SYSTEMS designed for more than one
rated voltage shall be tested in conditions related to the least favourable voltage and nature
of supply.
c) HEARING INSTRUMENTS AIDS for which alternative ACCESSORIES or detachable parts can be
connected as specified in the ACCOMPANYING DOCUMENTS shall be tested with those
ACCESSORIES or detachable parts that result in the least favourable conditions.
d) If the instructions for use specify that a HEARING INSTRUMENT AID or a HEARING INSTRUMENT
AID SYSTEM is intended to receive its power from a separate power supply, it shall be
connected to such a power supply.
201.5.7 Humidity preconditioning treatment
Replacement:
Where climatic conditions could influence the safety of a HEARING INSTRUMENT AID or HEARING
INSTRUMENT AID SYSTEM or its parts, it shall be subjected to a humidity preconditioning treatment
prior to the tests of 201.8.7.4.

HEARING INSTRUMENTS AID and HEARING INSTRUMENT AID SYSTEMS or their parts shall be set up
completely (or where necessary partially). Covers used during transport and storage shall be
detached.
Parts that can be detached without the use of tools shall be detached, but tested simultaneously
with the major part.
ACCESS COVERS that can be opened or detached without the use of tools shall be opened and
detached.
The humidity preconditioning treatment shall be performed in a humidity cabinet containing air
with a relative humidity of 93 % ± 3 % where the ME EQUIPMENT or its parts under test are located.
The humidity conditions at other locations in the chamber may vary by ±6 %. The temperature
of the air in the cabinet, at all places where HEARING INSTRUMENTS AIDS and HEARING INSTRUMENT
AID SYSTEMS can be located, shall be maintained within 2 °C of any convenient value T in the
range of +20 °C to +30 °C. Before being placed in the humidity cabinet, HEARING INSTRUMENTS
AIDS and HEARING INSTRUMENT AID SYSTEMS are brought to a temperature between T and T + 4 °C,
and kept at this temperature for at least 4 h before the humidity treatment starts.
Keep HEARING INSTRUMENTS AIDS and HEARING INSTRUMENT AID SYSTEMS and their parts, where
the ENCLOSURE is classified as IPX0, in the humidity cabinet for at least 48 h.
Keep HEARING INSTRUMENTS AIDS and HEARING INSTRUMENT AID SYSTEMS and its parts, where the
ENCLOSURE is designed to provide higher ingress protection against liquids, in the humidity
cabinet for 168 h.
201.5.9 Determination of APPLIED PARTS and ACCESSIBLE PARTS
201.5.9.1 * APPLIED PARTS
Addition:
The HEARING INSTRUMENT AID is a TYPE B APPLIED PART in the HEARING INSTRUMENT AID SYSTEM. If
any other parts have to be in contact with the PATIENT, those parts are also TYPE B APPLIED PARTS.
201.5.9.2 ACCESSIBLE PARTS
201.5.9.2.1 Test finger
Addition:
The tests as described in the general standard are additionally performed with the small finger
probe shown in Figure 1 of IEC 60601-1-11:20102015.
201.5.201 SOUND PRESSURE LEVEL
Any sound pressure level specified in this document is measured in decibels (dB) as described
in IEC 60118-0:2015.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies, except as follows:
201.6.2 Protection against electric shock
Replacement:
– 16 – IEC 60601-2-66:2019 RLV © IEC 2019
HEARING INSTRUMENTS AIDS are INTERNALLY POWERED, but may have connections to mains
supplied equipment. The insulation between the SUPPLY MAINS and the HEARING INSTRUMENT AID
shall be provided within the power supply, charger or other type of ACCESSORY.
The HEARING INSTRUMENT AID is classified a TYPE B APPLIED PART.
201.6.3 Protection against harmful ingress of water or particulate matter
Replacement:
See 201.11.6.5.
201.6.6 Mode of operation
Replacement:
HEARING INSTRUMENTS AIDS are classified for CONTINUOUS OPERATION.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.1 General
201.7.1.1 USABILITY of the identification, marking and documents
Replacement:
The MANUFACTURER shall address in the RISK MANAGEMENT PROCESS the RISK of poor USABILITY
associated with the design of the HEARING INSTRUMENT’S AIDS identification, marking and
documents.
The USABILITY of the identification, marking and ACCOMPANYING DOCUMENTS intended for the
PATIENT shall be evaluated based on a PATIENT profile that includes basic school education.
HEARING instruments AIDS should be designed to be simple to use and not require reference to
complex ACCOMPANYING DOCUMENTS.
Compliance shall be checked by inspection of the results of the RISK MANAGEMENT PROCESS.
201.7.1.2 Legibility of markings
Replacement:
The markings required by 7.2 and 7.3 shall be CLEARLY LEGIBLE under the following conditions:
– safety signs and identification, on the HEARING INSTRUMENT AID except serial number, shall
be CLEARLY LEGIBLE when it is placed in the hand of the PATIENT;
– the serial number and any other markings shall be legible utilizing an optical aid if necessary.
ME EQUIPMENT or ME EQUIPMENT parts
201.7.2 Marking on the outside of
201.7.2.1 Minimum requirements for marking on HEARING INSTRUMENT ME EQUIPMENT and
on interchangeable parts
Replacement:
If the size of the HEARING INSTRUMENT AID does not allow affixation of all markings specified in
7.2, the markings shall be recorded in full in the ACCOMPANYING DOCUMENTS.
201.7.2.2 Identification
Replacement:
HEARING INSTRUMENTS AIDS shall be marked on the outside with:
– the name or trademark of the MANUFACTURER;
– a MODEL OR TYPE REFERENCE.
HEARING INSTRUMENTS AIDS shall be marked visibly on the outside or other user accessible
location:
– identification of right and left HEARING INSTRUMENT AID unless absence of this marking does
not present an unacceptable RISK. Right is defined by the colour red. Left is defined by the
colour blue;
– serial number.
In case of 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. Where it is not
possible, the whole applicable labelling information may be placed on the packaging for each
unit.
HEARING INSTRUMENTS AIDS shall be marked visibly on the outside or other user accessible
location or on the package with:
– the year of manufacture.
The serial number, lot or batch identifier, and the year of manufacture may be provided in a
human readable code or through automatic identification technology such as barcodes or RFID
(radio-frequency identification).
NOTE See ISO 15223-1 for symbols for MANUFACTURER, serial number, lot or batch, year of manufacture and use
by date.
201.7.2.5 ME EQUIPMENT intended to receive power from other equipment
Subclause 7.2.5 of the general standard does not apply.
201.7.2.6 Connection to the SUPPLY MAINS
Subclause 7.2.6 of the general standard does not apply.
201.7.2.7 Electrical input power from the SUPPLY MAINS
Subclause 7.2.7 of the general standard does not apply.
201.7.2.8 Output connectors
Subclause 7.2.8 of the general standard does not apply.
201.7.2.10 APPLIED PARTS
Subclause 7.2.10 of the general standard does not apply.
201.7.2.17 Protective packaging
Replacement:
– 18 – IEC 60601-2-66:2019 RLV © IEC 2019
If special handling measures have to be taken during transport or storage, the packaging shall
be marked accordingly.
201.7.8.1 * Colours of indicator lights
Replacement:
The colours of indicator lights and their meanings shall be stated in the instructions for use.
Compliance with the requirements is checked by inspection.
201.7.9 ACCOMPANYING DOCUMENTS
201.7.9.1 General
Replacement:
HEARING INSTRUMENTS AIDS shall be accompanied by documents containing at least the
instructions for use and a technical description. The technical description may be included in
the same document as the instructions for use. The ACCOMPANYING DOCUMENTS shall be
regarded as a part of the HEARING INSTRUMENT AID.
The ACCOMPANYING DOCUMENTS shall identify the HEARING INSTRUMENT AID by including, as
applicable, the following:
– name or trade-name of the MANUFACTURER contact information to which the PATIENT can refer;
– MODEL OR TYPE REFERENCE;
– for HEARING INSTRUMENTS AIDS able to provide more than 132 dB SPL: warning to the
professional OPERATOR fitting the HEARING INSTRUMENT AID that there may be a RISK of
impairing the remaining hearing of the PATIENT.
ACCOMPANYING DOCUMENTS may be provided electronically, e.g. electronic file format on CD-
ROM that can be publicly downloaded.
If the ACCOMPANYING DOCUMENTS are provided electronically, the USABILITY ENGINEERING PROCESS
shall include consideration of which information also needs to be provided as hard copy.
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.
Compliance shall be checked by inspection of the ACCOMPANYING DOCUMENTS, and, when
provided electronically, as specified in IEC 60601-1-6.
201.7.9.2 Instructions for use
201.7.9.2.1 General
Replacement:
The instructions for use shall document:
– the name or trademark and address of the MANUFACTURER;
– the MODEL OR TYPE REFERENCE;
– the purpose and INTENDED USE of the HEARING INSTRUMENT AID;
– the operating functions;
– identification of any known side effects associated with the use of HEARING instrument AID
that may warrant consultation with a physician, for example accumulation of cerumen.

The instructio
...