IEC 60601-2-66:2015

IEC 60601-2-66


®


Edition 2.0 2015-06



INTERNATIONAL



STANDARD



NORME
INTERNATIONALE


Medical electrical equipment –
Part 2-66: Particular requirements for the basic safety and essential performance
of hearing instruments and hearing instrument systems

Appareils électromédicaux –
Partie 2-66: Exigences particulières pour la sécurité de base et les performances
essentielles des instruments d'audition et systèmes d'audition


IEC 60601-2-66:2015-06(en-fr)

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IEC 60601-2-66



®



Edition 2.0 2015-06







INTERNATIONAL





STANDARD







NORME



INTERNATIONALE











Medical electrical equipment –

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

of hearing instruments and hearing instrument systems




Appareils électromédicaux –

Partie 2-66: Exigences particulières pour la sécurité de base et les performances


essentielles des instruments d'audition et systèmes d'audition















INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE


INTERNATIONALE




ICS 11.180.15; 17.140.50 ISBN 978-2-8322-2766-4



Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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– 2 – IEC 60601-2-66:2015 © IEC 2015


CONTENTS


FOREWORD . 3

INTRODUCTION . 5


201.1 Scope, object and related standards . 6

201.2 Normative references . 8

201.3 Terms and definitions . 8

201.4 General requirements . 10

201.5 General requirements for testing ME EQUIPMENT . 10

201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 13
201.8 *Protection against electrical HAZARDS from ME EQUIPMENT . 18
201.9 *Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 21
201.10 Protection against unwanted and excessive radiation HAZARDS . 23
201.11 *Protection against excessive temperatures and other HAZARDS . 23
201.12 *Accuracy of controls and instruments and protection against hazardous
outputs . 24
201.13 *HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 25
201.14 *PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 28
201.15 *Construction of ME EQUIPMENT . 29
201.16 *ME SYSTEMS . 31
201.17 *Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 31
Annexes . 32
Annex E (informative) Examples of the connection of the measuring device (MD) for
measurement of THE PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT . 32
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 32
Annex H (informative) PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE and
documentation . 32
Annex I (informative) ME SYSTEMS aspects . 32
Annex J (informative) Survey of insulation paths . 32
Annex K (informative) Simplified PATIENT LEAKAGE CURRENT diagrams . 33
Annex L (normative) Insulated winding wires for use without interleaved insulation . 33

Annex AA (informative) Particular guidance and rationale . 34
Annex BB (informative) Abbreviations . 39
Bibliography . 40
Index of defined terms used in this particular standard . 41

Figure 201.101 – Measuring circuit for LEAKAGE CURRENT . 20

Table 201.102 – MECHANICAL HAZARDS to be considered . 21
Table AA.101 – Summary of the approach of this standard . 35

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IEC 60601-2-66:2015 © IEC 2015 – 3 –


INTERNATIONAL ELECTROTECHNICAL COMMISSION


____________




MEDICAL ELECTRICAL EQUIPMENT –



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

performance of hearing instruments and hearing instrument 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,
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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
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between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
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5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
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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
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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.

International Standard IEC 60601-2-66 has been prepared by IEC technical committee 29:
Electroacoustics.
This second edition cancels and replaces the first edition published in 2012. It constitutes a
technical revision to adapt IEC 60601-2-66:2012 to the technical corrections introduced by
Amendment 1 (2012) to IEC 60601-1:2005, as well as to clarify and correct the wording of this
particular standard and to implement minor changes requested by interested parties.
The text of this standard is based on the following documents:
FDIS Report on voting
29/851/FDIS 29/869/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.

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– 4 – IEC 60601-2-66:2015 © IEC 2015


This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.


In this standard, 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 standard, 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 standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, 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 standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “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 publication will remain unchanged until

the stability date indicated on the IEC website 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.

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IEC 60601-2-66:2015 © IEC 2015 – 5 –


INTRODUCTION


In 1998 the HEARING INSTRUMENT industry represented by the 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 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 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.

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– 6 – IEC 60601-2-66:2015 © IEC 2015


MEDICAL ELECTRICAL EQUIPMENT –



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

performance of hearing instruments and hearing instrument systems








201.1 Scope, object and related standards


1
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This International Standard applies to the BASIC SAFETY of HEARING INSTRUMENTS and HEARING
INSTRUMENT 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 only,
or to HEARING INSTRUMENT 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
and to HEARING INSTRUMENT SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of HEARING INSTRUMENTS or HEARING
INSTRUMENT SYSTEMS within the scope of this standard are not covered by specific
requirements in this standard except in 201.7.9.2 and 201.9.6.
NOTE See also 201.4.2. (RISK MANAGEMENT).
ACCESSORIES to HEARING INSTRUMENTS in the HOME HEALTHCARE ENVIRONMENT (e.g. remote
control units, audio streamers, battery chargers, power supplies) are covered by the most
applicable standard, IEC 60065, IEC 60950-1 or other applicable IEC safety standards.
Alternatively the general standard may be applied. HEARING INSTRUMENTS do not have a MAINS
PART intended for connection to a.c. SUPPLY MAINS. The connection to the SUPPLY MAINS of a
HEARING INSTRUMENT 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.
NOTE Detachable parts of HEARING INSTRUMENTS even if supplied separately (e.g. ear hooks, domes, wax guards
etc.), are not regarded as ACCESSORIES.
This standard does not apply to:
– cochlear implants or other implanted HEARING INSTRUMENTS;
– bone conduction HEARING INSTRUMENTS;
___________
1
The general standard is IEC 60601-1:2005+A1:2012, Medical electrical equipment – Part 1: General

requirements for basic safety and essential performance.

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IEC 60601-2-66:2015 © IEC 2015 – 7 –


– educational HEARING INSTRUMENTS (i.e. group HEARING INSTRUMENTS, auditory trainers etc.);

– the application of a HEARING INSTRUMENT for the measurement of hearing levels.

IEC 60645-1 applies;


– 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.


201.1.2 Object


Replacement:
The object of this particular standard is to establish particular BASIC SAFETY requirements for
HEARING INSTRUMENTS and HEARING INSTRUMENT 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.
IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-9, 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.
For brevity, IEC 60601-1 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 standard 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.

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– 8 – IEC 60601-2-66:2015 © IEC 2015


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, additional definitions in this standard 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 standard" 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
Clause 2 of the general standard applies except as follows:
Replacement:
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 characteristics
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
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 apply, except as follows:
NOTE An index of defined terms is found beginning on page 41.

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IEC 60601-2-66:2015 © IEC 2015 – 9 –


201.3.73

OPERATOR

Addition:


Note 1 to entry: Usually equal to patient for hearing instruments in a home healthcare environment.


201.3.76

PATIENT

Addition:


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 standard in line with the general terminology in the medical product field. It
is however understood, that the user of a HEARING INSTRUMENT is typically not an ill person but someone healthy
with a hearing impairment in a HOME HEALTHCARE ENVIRONMENT.
201.3.113
SERVICE PERSONNEL
Replacement:
individuals or entity that assemble, maintain or repair HEARING INSTRUMENTS or HEARING
INSTRUMENT 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
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 includes all detachable parts that are essential for the performance of its
intended use.
201.3.203
HEARING SYSTEM
HEARING INSTRUMENT SYSTEM
combination, as specified by its MANUFACTURER, of items of equipment, at least one of which
is a HEARING INSTRUMENT to be inter-connected by FUNCTIONAL CONNECTION
201.3.204
SOUND PRESSURE LEVEL
SPL
L
p
ten times the logarithm to the base 10 of the ratio of the square of the sound pressure, p, to
the square of a reference value, p , expressed in decibels
0

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– 10 – IEC 60601-2-66:2015 © IEC 2015


2
p

L = 10lg dB
p
2

p
0



where the reference value, p , is 20 µPa
0


2
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-
...