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

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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

– 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

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
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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.

– 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.
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 – 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

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+A1:2012, Medical electrical equipment – Part 1: General

requirements for basic safety and essential performance.

– 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.

– 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.

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
– 10 – IEC 60601-2-66:2015 © IEC 2015

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 80000-8:2007, 8-22.
Note 3 to entry: The note to entry concerning the origin of the English abbreviation “SPL” concerns the French text
only.
[SOURCE: ISO/TR 25417:2007, 2.2]
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
person for whom the HEARING INSTRUMENT or HEARING INSTRUMENT SYSTEMS is intended.
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.
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.
d) If the instructions for use specify that a HEARING INSTRUMENT or a HEARING INSTRUMENT
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.
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.
– 12 – IEC 60601-2-66:2015 © IEC 2015

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 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 + 30 °C. Before being placed in the humidity cabinet, HEARING

INSTRUMENTS and HEARING INSTRUMENT 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 and HEARING INSTRUMENT SYSTEMS and its parts, where the

ENCLOSURE is classified as IPX0, in the humidity cabinet for at least 48 h.

Keep HEARING INSTRUMENTS and HEARING INSTRUMENT 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:
HEARING INSTRUMENT is a TYPE B APPLIED PART in the HEARING INSTRUMENT SYSTEM. If any
The
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 60601-1-11:2010.
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:
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:
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 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 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 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 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.
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.
HEARING INSTRUMENTS shall be marked visibly on the outside or other user accessible location:

– 14 – IEC 60601-2-66:2015 © IEC 2015

– 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.

HEARING INSTRUMENTS 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:
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:
– name or trade-name of the MANUFACTURER contact information to which the PATIENT can
refer;
– model or type reference.
– for HEARING INSTRUMENTS able to provide more than 132 dB SPL: warning to the
professional OPERATOR fitting the HEARING INSTRUMENT that there may be a RISK of
impairing the remaining hearing of the PATIENT;
ACCOMPANYING DOCUMENTS may be provided electronically, e.g. electronic file format on CD-
ROM.
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;
– the operating functions;
– identification of any known side effects associated with the use of hearing instrument that
may warrant consultation with a physician e.g. accumulation of cerumen.
The instructions for use shall be in a language that is acceptable to the intended PATIENT.
The instructions for use shall include
– easily understood diagrams, illustrations, or photographs of the fully assembled and
ready-to-operate HEARING INSTRUMENT including all controls, visual information signals, and
indicators;
– easily understood diagrams, illustrations, or photographs showing proper connection of
the PATIENT to the HEARING INSTRUMENT, ACCESSORIES and other equipment;
– any restrictions on locations or environments in which the HEARING INSTRUMENT can be
used;
– advice to the PATIENT to contact the MANUFACTURER or the MANUFACTURER'S representative:

– 16 – IEC 60601-2-66:2015 © IEC 2015

• for assistance, if needed, in setting up, using or maintaining the HEARING INSTRUMENT

or HEARING INSTRUMENTS SYSTEM; or

• to report unexpected operation or events.

The instructions for use shall include a description and illustration on how to replace and/or

recharge batteries.
201.7.9.2.2 Warning and safety notices

Replacement:
The instructions for use shall include all warning and safety notices.
General warnings and safety notices should be placed in a specifically identified section of the
instructions for use. A warning or safety notice that applies only to a specific instruction or
action should precede the instruction to which it applies.
Where relevant, the instructions for use shall state:
– for HEARING INSTRUMENTS in paediatric applications: warning to keep small parts (HEARING
INSTRUMENTS, batteries and detachable parts) that can be swallowed out of children’s
reach;
– for HEARING INSTRUMENTS that do not comply with requirements for explosive or oxygen-
enriched atmospheres: warning not to use the HEARING INSTRUMENT in such areas;
– warning that the specific HEARING INSTRUMENT must only be used by the intended person
and not by others;
– for HEARING INSTRUMENTS with wireless transmission: warning to check first before using
the HEARING SYSTEM in areas where electronics or wireless devices are restricted;
– statement required about the special needs of particular PATIENT groups e.g. small children
or mentally disabled persons;
– warning about common conditions that could damage the HEARING INSTRUMENT such as
dropping, immersing in liquid, strong electromagnetic fields or excessive heat;
– other warnings that may result from the risk assess
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