EN 60601-2-66:2013

SLOVENSKI STANDARD
01-marec-2013
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Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and
essential performance of hearing instruments and hearing instrument systems
Medizinische elektrische Geräte - Teil 2-66: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Hörgeräten und
Hörgerätesystemen
Appareils électromédicaux - Partie 2-66: Exigences particulières pour la sécurité de base
et les performances essentielles des instruments d'audition et systèmes d'audition
Ta slovenski standard je istoveten z: EN 60601-2-66:2013
ICS:
11.180.15 3ULSRPRþNL]DJOXKHRVHEHLQ Aids for deaf and hearing
RVHEH]RNYDURVOXKD impaired people
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 60601-2-66
NORME EUROPÉENNE
January 2013
EUROPÄISCHE NORM
ICS 11.180.15; 17.140.50
English version
Medical electrical equipment -
Part 2-66: Particular requirements for the basic safety and essential
performance of hearing instruments and hearing instrument systems
(IEC 60601-2-66:2012)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-66: Exigences particulières pour Teil 2-66: Besondere Festlegungen für die
la sécurité de base et les performances Sicherheit einschließlich der wesentlichen
essentielles des instruments d'audition Leistungsmerkmale von Hörgeräten
et systèmes d'audition und Hörgerätesystemen
(CEI 60601-2-66:2012) (IEC 60601-2-66:2012)

This European Standard was approved by CENELEC on 2012-11-06. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the CEN-CENELEC Management Centre or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and notified
to the CEN-CENELEC Management Centre has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus,
the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels

© 2013 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-66:2013 E
Foreword
The text of document 29/777/FDIS, future edition 1 of IEC 60601-2-66, prepared by IEC/TC 29
"Electroacoustics" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
(dop) 2013-08-06
• latest date by which the document has
to be implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2015-11-06
• latest date by which the national
standards conflicting with the
document have to be withdrawn
This standard is to be read in conjunction with EN 60601-1:2006.

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.

- 3 - EN 60601-2-66:2013
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).

For the relationship with EU Directive(s) see informative Annex ZZ, which is an integral part of this
document.
Endorsement notice
The text of the International Standard IEC 60601-2-66:2012 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:

IEC 60118-4:2006 NOTE Harmonised as EN 60118-4:2006 (not modified).
IEC 60318-5:2006 NOTE Harmonised as EN 60318-5:2006 (not modified).
IEC 60601-1-4:1996 NOTE Harmonised as EN 60601-1-4:1996 (not modified).
IEC 60645-1:2001 NOTE Harmonised as EN 60645-1:2001 (not modified).
IEC 61672-1:2002 NOTE Harmonised as EN 61672-1:2003 (not modified).
IEC 62489-1:2010 NOTE Harmonised as EN 62489-1:2010 (not modified).
ISO 80000-8:2007 NOTE Harmonised as EN ISO 80000-8:2007 (not modified).

Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

Annex ZA of EN 60601-1:2006 applies, except as follows:
In Annex ZA of EN 60601-1:2006 replace the introductory paragraph by the following:

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.

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Publication Year Title EN/HD Year

In Annex ZA of EN 60601-1:2006 replace IEC 60950-1:2001 by:
IEC 60950-1 (mod) 2005 Information technology equipment - Safety - EN 60950-1 2006
+ corr. August 2006 Part 1: General requirements + AC:2011 2011
+ A11 2009
+ A12 2011
Add to Annex ZA of EN 60601-1:2006 the following new references:
IEC 60065 (mod) 2001 Audio, video and similar electronic apparatus EN 60065 2002
+ corr. August 2002 - Safety requirements + corr. August 2007
+ A11 2008
+ A12 2011
IEC 60118-7 2005 Electroacoustics - Hearing aids - EN 60118-7 2005
Part 7: Measurement of the performance
characteristics of hearing aids for production,
supply and delivery quality assurance
purposes
IEC 60118-13 - Electroacoustics - Hearing aids - EN 60118-13 -
Part 13: Electromagnetic compatibility (EMC)

IEC 60601-1-11 2010 Medical electrical equipment - EN 60601-1-11 2010
+ corr. April 2011 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 EN 62304 -
life-cycle processes
IEC 62366 2007 Medical devices - Application of usability EN 62366 2008
engineering to medical devices

- 5 - EN 60601-2-66:2013
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives

This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EU Directive 93/42/EEC except the
following:
– Essential Requirements 1 to 7.1
– Essential Requirement 7.4
– Essential Requirement 7.5, Paragraphs 2 and 3
– Essential Requirement 13.6 (q)

Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.

WARNING: Other requirements and other EU Directives may be applicable to the products falling
within the scope of this standard.

IEC 60601-2-66 ®
Edition 1.0 2012-10
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
PRICE CODE
INTERNATIONALE
CODE PRIX X
ICS 11.180.15; 17.140.50 ISBN 978-2-83220-381-1

– 2 – 60601-2-66 © IEC:2012
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 6
201.2 Normative references . 8
201.3 Terms and definitions . 9
201.4 General requirements . 10
201.5 General requirements for testing ME EQUIPMENT . 11
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 . 25
201.14 *PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 28
201.15 *Construction of ME EQUIPMENT . 28
201.16 *ME SYSTEMS . 30
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 . 33
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 the LEAKAGE CURRENT . 20

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

60601-2-66 © IEC:2012 – 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,
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.
International Standard IEC 60601-2-66 has been prepared by IEC technical committee 29:
Electroacoustics.
The text of this particular standard is based on the following documents:
FDIS Report on voting
29/777/FDIS 29/792/RVD
Full information on the voting for the approval of this particular standard 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 standard, the following print types are used:

– 4 – 60601-2-66 © IEC:2012
– 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 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.
60601-2-66 © IEC:2012 – 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.

– 6 – 60601-2-66 © IEC:2012
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
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;
—————————
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for

basic safety and essential performance.

60601-2-66 © IEC:2012 – 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.

– 8 – 60601-2-66 © IEC:2012
"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, 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 of the introductory paragraph:
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.
NOTE Informative references are listed in the bibliography.
Replacement:
IEC 60950-1:2005, Information technology equipment – Safety – Part 1: General requirements
Addition:
IEC 60065:2001, 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 60118-13, Electroacoustics – Hearing aids – Part 13: Electromagnetic compatibility
(EMC)
IEC 60601-1-11:2010, 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

60601-2-66 © IEC:2012 – 9 –
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
apply, except as follows:
NOTE An index of defined terms is found beginning on page 41.
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. A HEARING INSTRUMENT includes all detachable parts that are essential for the
performance of its intended use.

– 10 – 60601-2-66 © IEC:2012
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
p
L = 10lg dB
p
p
where the reference value, p , is 20 µPa
[SOURCE: ISO/TR 25417:2007, 2.2]
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-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 80000-8:2007, 8-22.
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 standard shall apply in NORMAL USE and
reasonably foreseeable misuse.
When applying this standard to HEARING INSTRUMENTS or HEARING INSTRUMENT SYSTEMS, the
definitions and requirements that use the term PATIENT shall be considered as applying to the
HEARING INSTRUMENT or HEARING INSTRUMENT SYSTEMS is intended.
person for whom the
201.4.3 * ESSENTIAL PERFORMANCE
Replacement:
HEARING INSTRUMENTS do not have an ESSENTIAL PERFORMANCE.
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.

60601-2-66 © IEC:2012 – 11 –
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 or HEARING INSTRUMENT 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 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 and HEARING INSTRUMENT 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 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.
HEARING INSTRUMENT or a HEARING INSTRUMENT
d) If the instructions for use specify that a
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 or HEARING
INSTRUMENT SYSTEM or its parts, it shall be subjected to a humidity preconditioning treatment
prior to the tests of 201.8.7.4.
HEARING INSTRUMENTS and HEARING INSTRUMENT SYSTEMS or theirs parts shall be set up
completely (or where necessary partially). Covers used during transport and storage shall be
detached.
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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%. The temperature of the air in the cabinet, at all places
where HEARING INSTRUMENTS and HEARING INSTRUMENT SYSTEMS can be located, shall be
maintained within 2 °C of any convenient value T in the range of + 20 °C to + 32 °C. Before
being placed in the humidity cabinet, HEARING INSTRUMENTS and HEARING INSTRUMENT SYSTEMS
shall be brought to a temperature between T and T + 4 °C, and kept at this temperature for at
least 4 h before the humidity treatment.
HEARING INSTRUMENTS and HEARING INSTRUMENT SYSTEMS and its parts shall be kept in the
humidity cabinet for at least 48 h.
201.5.9 Determination of APPLIED PARTS and ACCESSIBLE PARTS
PPLIED PARTS
201.5.9.1 *A
Addition:
The HEARING INSTRUMENT is a TYPE B APPLIED PART in the HEARING INSTRUMENT 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.
201.5.201 SOUND PRESSURE LEVEL
Any sound pressure level specified in this document is measured in decibels (dB) as
described in IEC 60118-7:2005.
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:
HEARING INSTRUMENTS are INTERNALLY POWERED, but may have connections to mains supplied
equipment. The insulation between the SUPPLY MAINS and the HEARING INSTRUMENT shall be
provided within the power supply, charger or other type of ACCESSORY.
The HEARING INSTRUMENT is classified a TYPE B APPLIED PART.
201.6.3 Protection against harmful ingress of water or particulate matter
Replacement:
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See 201.11.6.5.
201.6.6 Mode of operation
Replacement:
HEARING INSTRUMENTS are classified for CONTINUOUS OPERATION.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.1.1 USABILITY of the identification, marking and documents
Replacement:
The MANUFACTURER shall address in the RISK MANAGEMENT PROCESS the RISK of poor USABILITY
HEARING INSTRUMENT’S identification, marking and
associated with the design of the
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 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:
HEARING INSTRUMENT except serial number, shall be
– Safety signs and identification, on the
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.
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
201.7.2.1 Minimum requirements for marking on HEARING INSTRUMENT
Replacement:
If the size of the HEARING INSTRUMENT 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 shall be marked on the outside with:
– the name or trademark of the MANUFACTURER;
– a MODEL OR TYPE REFERENCE.
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HEARING INSTRUMENTS shall be marked visibly on the outside or inside when the battery drawer
is open, with:
– identification of right and left HEARING INSTRUMENT 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 worn in the ear, the marking on the instrument may be
reduced to the serial number and the identification of right and left.
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:
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 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.
The ACCOMPANYING DOCUMENTS shall identify the HEARING INSTRUMENT by including, as
applicable, the following:
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– name or trade-name of the MANUFACTURER and an address to which the PATIENT can refer;
– model or type reference.
ACCOMPANYING DOCUMENTS may be provided electronically, e.g. electronic file format on CD-
ROM.
If the ACCOMPANYING DOCUMENTS are provided electronically, the RISK MANAGEMENT PROCESS
shall include consideration of which information also needs to be provided
...