SIST EN 60601-2-66:2016

SLOVENSKI STANDARD
SIST EN 60601-2-66:2016
01-marec-2016
1DGRPHãþD
SIST EN 60601-2-66:2013
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLVOXãQLKSULSRPRþNRYLQVLVWHPRYVOXãQLKLQVWUXPHQWRY
Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and
essential performance of hearing instruments and hearing instrument systems
Ta slovenski standard je istoveten z: EN 60601-2-66:2015
ICS:
11.180.15 3ULSRPRþNL]DJOXKHRVHEHLQ Aids for deaf and hearing
RVHEH]RNYDURVOXKD impaired people
SIST EN 60601-2-66:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-66:2016

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SIST EN 60601-2-66:2016


EUROPEAN STANDARD EN 60601-2-66

NORME EUROPÉENNE

EUROPÄISCHE NORM
November 2015
ICS 11.180.15; 17.140.50 Supersedes EN 60601-2-66:2013
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 60601-2-66:2015)
Appareils électromédicaux - Partie 2-66: Exigences Medizinische elektrische Geräte - Teil 2-66: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des instruments d'audition et systèmes wesentlichen Leistungsmerkmale von Hörgeräten und
d'audition Hörgerätesystemen
(IEC 60601-2-66:2015) (IEC 60601-2-66:2015)
This European Standard was approved by CENELEC on 2015-07-31. 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.


European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 60601-2-66:2015 E

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SIST EN 60601-2-66:2016
EN 60601-2-66:2015
European foreword
The text of document 29/851/FDIS, future edition 2 of IEC 60601-2-66, prepared by
IEC/TC 29 "Electroacoustics" was submitted to the IEC-CENELEC parallel vote and approved by
CENELEC as EN 60601-2-66:2015.

The following dates are fixed:
• latest date by which the document has to be (dop) 2016-05-27
implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2018-07-31
• latest date by which the national
standards conflicting with the
document have to be withdrawn

This document supersedes 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 60601-2-66:2015 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 60118-4:2014 NOTE Harmonized as EN 60118-4:2015 (not modified).
IEC 60318-5:2006 NOTE Harmonized as EN 60318-5:2006 (not modified).
IEC 60601-1-4:1996 NOTE Harmonized as EN 60601-1-4:1996 (not modified).
IEC 60601-1-9 NOTE Harmonized as EN 60601-1-9.
IEC 60601-1-10 NOTE Harmonized as EN 60601-1-10.
IEC 60645-1:2012 NOTE Harmonized as EN 60645-1:2015 (not modified).
IEC 62489-1:2010 NOTE Harmonized as EN 62489-1:2010 (not modified).
ISO 80000-8:2007 NOTE Harmonized as EN ISO 80000-8:2007 (not modified).

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SIST EN 60601-2-66:2016
EN 60601-2-66:2015
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications
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 1 When an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is
available here: www.cenelec.eu.

Annex ZA of EN 60601-1:2006 applies except as follows:

Publication Year Title EN/HD Year
Replacement:
IEC 60950-1 2005 Information technology equipment - EN 60950-1 2006
(mod) Safety - Part 1: General requirements +AC 2011
  +A11 2009
+A1 (mod) 2009 +A1 2010
  +A12 2011
+A2 (mod) 2013 +A2 2013
Addition:
IEC 60118-0 2015 Electroacoustics - Hearing aids - EN 60118-0 2015
Part 0: Measurement of the performance
characteristics of hearing aids
IEC 60118-13 -  Electroacoustics - Hearing aids - EN 60118-13 -
Part 13: Electromagnetic compatibility
(EMC)
IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic + corr. March 2010
safety and essential performance
+A1 2012 +A1 2013
+A1/AC 2014
  +A12 2014
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SIST EN 60601-2-66:2016
EN 60601-2-66:2015
Publication Year Title EN/HD Year
IEC 60601-1-11 2015 Medical electrical equipment - EN 60601-1-11 2015
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- EN 62304 -
cycle processes
IEC 62366 2007 Medical devices - Application of usability EN 62366 2008
engineering to medical devices
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SIST EN 60601-2-66:2016
EN 60601-2-66:2015
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 to provide a means of conforming to the
Essential Requirements given in Annex I of the EU Directives 93/42/EEC as amended by 2007/47/EC.
General Guidance:
Once this standard will be cited in the Official Journal of the European Union under that Directive,
compliance with the clauses of this standard given in Table ZZ.1 confers, within the limits of the scope
of this standard, a presumption of conformity with the corresponding Essential Requirements (ERs) of
that Directive and associated EFTA regulations.
NOTE 1 This standard is intended to be applied in its entirety only. Selected clauses or
subclauses may be not applicable due to the specific type of equipment under consideration. It is
necessary to understand and apply Clauses 1 to 5. It is also recommended to understand and apply
those clauses which contain general requirements related to a specific subclause. Elements of the
standard that are not cited in Table ZZ.1 may be relevant for the appropriate fulfilment of certain
essential requirements through indirect reference, and for safety and performance aspects of the
device, that are not addressed through essential requirements.
NOTE 2 Where a reference from a clause of this standard to the risk management process is
made, the risk management process needs to be in compliance to the MDD (Directive 93/42/EEC
amended by 2007/47/EC). This means that risks have to be reduced "as far as possible", "to a
minimum", "to the lowest possible level", "minimized" or "removed", according to the wording of the
corresponding essential requirement.
NOTE 3 With respect to Note 4 of 4.2.2 General requirement for risk management, the
manufacturer’s policy for determining acceptable risk must be in compliance with essential
requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the directive.
NOTE 4 References in the Clauses 3 to 17 or in the Annexes of this standard specify whether
the normative references listed in Clause 2 as cited in Annex ZA are to be applied in whole or in part.
NOTE 5 This Annex ZZ is based on Normative References according to Annex ZA, replacing
the references in the core text.
NOTE 6 According to the scope of this standard the coverage in Table ZZ.1 only applies to the
design and construction of HEARING INSTRUMENTS or HEARING INSTRUMENT SYSTEMS. This
European Standard lists in Table ZZ.1 only the essential requirements covered.
WARNING: Other requirements and other EU Directives and Regulations may be applicable to the
product(s) falling within the scope of this standard.
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SIST EN 60601-2-66:2016
EN 60601-2-66:2015
Table ZZ.1 – Relationship between Essential Requirements of Directive 93/42/EEC
amended by 2007/47/EC, and clauses and subclauses of this standard
No. Essential Requirements Coverage of EN 60601-2-66
I. GENERAL REQUIREMENTS
1 General Guidance note 2 and 3 shall be observed
1 The devices must be designed and manufactured in The application of EN 60601-2-66
such a way that, when used under the conditions and and the documents referenced in
for the purposes intended, they will not compromise the there (below referenced as “this
clinical condition or the safety of patients, or the safety document” or “this standard”)
and health of users or, where applicable, other support a manufacturer to design
persons, provided that any risks which may be HEARING INSTRUMENTS and HEARING
associated with their intended use constitute INSTRUMENT SYSTEMS (below
acceptable risks when weighed against the benefits to “devices”) in such a way that, when
the patient and are compatible with a high level of used under the conditions and for
protection of health and safety. the purposes intended, they will not
compromise the clinical condition
This shall include:
or the safety of patients, or the
safety and health of users or,
where applicable, other persons,
while accepting only risks
associated with their intended use
that constitute acceptable risks
when weighed against the benefits
to the patient and are compatible
with a high level of protection of
health and safety.
Details and exclusions supporting
this general statement follow in
order of the essential requirements
below.
Where the intended use of devices
exceeds the scope of this
document, the manufacturer may
need to apply additional methods to
achieve conformity to the essential
requirements.
Manufacturing aspects are not
covered by this document! This
statement applies to several
essential requirements below but
will not be repeated at each line, in
order to provide for a better
usability of this document.
– reducing, as far as possible, the risk of use error The application of this document
due to the ergonomic features of the device and (201.7.1.1, 201.12.2 with reference
the environment in which the device is intended to to EN 62366) reduces, as far as
be used (design for patient safety), and possible, the risk of use error due
to the ergonomic features of the
device and the environment in
which the device is intended to be
used.
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EN 60601-2-66:2015
No. Essential Requirements Coverage of EN 60601-2-66
– consideration of the technical knowledge, This document (201.7.9.1,
experience, education and training and where 201.7.9.2.2) puts consideration of
applicable the medical and physical conditions of the technical knowledge,
intended users (design for lay, professional, experience, education and training
disabled or other users). and where applicable the medical
and physical conditions of intended
users (design for lay, professional,
disabled or other users).
2 General Guidance note 2 and 3 shall be observed
2 The solutions adopted by the manufacturer for the The requirements of this document
design and construction of the devices must conform to for the design and construction of
safety principles, taking account of the generally the devices conform to safety
acknowledged state of the art. principles, taking account of the
generally acknowledged state of

the art at the time it has been
In selecting the most appropriate solutions, the
released (2014).
manufacturer must apply the following principles in the
This document references
following order:
EN ISO 14971, the application of
which (4.3) does provide for the
coverage of potential developments
and new conclusions in hearing aid
safety that became known after the
release of this particular standard.
The requirements of this document
have been established by selecting
the most appropriate solutions to
the particular devices and their
risks, by applying the following
principles in the following order:
– eliminate or reduce risks as far as possible
(inherently safe design and construction),
– where appropriate take adequate protection
measures including alarms if necessary, in relation
to risks that cannot be eliminated,
– inform users of the residual risks due to any
shortcomings of the protection measures adopted.
3 The devices must achieve the performances intended The performance aspect (clinical
by the manufacturer and be designed, manufactured evaluation) is not covered by this
and packaged in such a way that they are suitable for document unless basic safety is
one or more of the functions referred to in Article 1 (2) concerned.
(a), as specified by the manufacturer.
HEARING INSTRUMENTS do not have
ESSENTIAL PERFORMANCE (201.4.3).
If a manufacturer extends the
intended use to safety critical
functional claims, the resulting
ESSENTIAL PERFORMANCE is not
covered by application of this
particular standard.
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No. Essential Requirements Coverage of EN 60601-2-66
4 The characteristics and performances referred to in A failure of characteristics of
Sections 1, 2 and 3 must not be adversely affected to HEARING INSTRUMENTS could not
such a degree that the clinical conditions and safety of affect the clinical conditions and
the patients and, where applicable, of other persons safety of the patients and other
are compromised during the lifetime of the device as persons (201.4.3).
indicated by the manufacturer, when the device is
If a manufacturer extends the
subjected to the stresses which can occur during
intended use to safety critical
normal conditions of use.
functional claims, the resulting
ESSENTIAL PERFORMANCE is not
covered by application of this
particular standard.
5 General Guidance note 2 and 3 shall be observed
5 The devices must be designed, manufactured and Covered by requirements to design
packed in such a way that their characteristics and and packaging (201.7.2.17) to
performances during their intended use will not be withstand transport and storage
adversely affected during transport and storage taking with regards of mechanical strength
account of the instructions and information provided by (201.15.3), resistance to
the manufacturer. environmental conditions
(201.15.3.7) and the necessary
instructions (201.7.9.2.2).
6 General Guidance note 2 and 3 shall be observed
6 Any undesirable side-effect must constitute an The requirements of this document
acceptable risk when weighed against the are sufficient to keep risks to an
performances intended. acceptable level when weighed
against the performances intended.
This document also references
EN ISO 14971, the application of
which requires the criteria for
acceptable risks (3.2).
In general, HEARING INSTRUMENTS
do not have side-effects beyond
convenience issues.
The reduction of unintentional
exposure to excessive acoustic
noise is covered in 201.9.6
regarding the design, in 201.7
regarding correct application
201.13.1.2 in case of faults.
6a Demonstration of conformity with the essential The performance aspect (clinical
requirements must include a clinical evaluation in evaluation) is not covered by this
accordance with Annex X. document unless basic safety is
concerned.
II. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION
7 Chemical, physical and biological properties General Guidance note 2 and 3
shall be observed
7.1 The devices must be designed and manufactured in See section I and the details in the
such a way as to guarantee the characteristics and three indents below.
performances referred to in Section I on the ‘General
requirements’. Particular attention must be paid to:
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SIST EN 60601-2-66:2016
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No. Essential Requirements Coverage of EN 60601-2-66
– the choice of materials used, particularly as Covered in respect of the toxicity:
regards toxicity and, where appropriate,
11.7 Biocompatibility, the
flammability,
manufacturer should apply the
appropriate part of the
EN ISO 10993 series.
Flammability:
Risks of fire and high temperatures
covered in 201.11.1.1, 201.13.1.2.
– the compatibility between the materials used and Covered in respect of the
biological tissues, cells and body fluids, taking biocompatibility:
account of the intended purpose of the device,
11.7 the manufacturer should apply
the appropriate part of the
EN ISO 10993 series.
– where appropriate, the results of biophysical or Such modelling research is not
modelling research whose validity has been applicable to HEARING
demonstrated beforehand. INSTRUMENTS.
7.2 The devices must be designed, manufactured and Covered in respect of the
packed in such a way as to minimize the risk posed by biocompatibility:
contaminants and residues to the persons involved in
11.7 the manufacturer should apply
the transport, storage and use of the devices and to the
the appropriate part of the
patients, taking account of the intended purpose of the
EN ISO 10993 series.
product. Particular attention must be paid to the tissues
exposed and to the duration and frequency of
exposure.
7.3 The devices must be designed and manufactured in This document covers (201.15.3.7,
such a way that they can be used safely with the 201.11.6.6) the design of devices in
materials, substances and gases with which they enter such a way that they can be used
into contact during their normal use or during routine safely with the materials,
procedures; substances and gases with which
they enter into contact during their
normal use or during routine
procedures.
The requirements for HEARING
INSTRUMENTS that are intended to
be used in explosive and oxygen-
enriched atmospheres are not
contained in this standard
(201.11.2).
if the devices are intended to administer medicinal HEARING INSTRUMENTS are not
products, they must be designed and manufactured in intended to administer medicinal
such a way as to be compatible with the medicinal products.
products concerned according to the provisions and
restrictions governing these products and that their
performance is maintained in accordance with the
intended use.
7.4 Where a device incorporates, as an integral part, a Not applicable to HEARING
substance which, if used separately, may be INSTRUMENTS.
considered to be a medicinal product as defined in
Article 1 of Directive 2001/83/EC and which is liable to
act upon the body with action ancillary to that of the
device, the quality, safety and usefulness of the
substance must be verified by analogy with the
methods specified in Annex I to Directive 2001/83/EC.
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No. Essential Requirements Coverage of EN 60601-2-66
7.5 The devices must be designed and manufactured in Covered by a warning in
such a way as to reduce to a minimum the risks posed 201.7.9.2.4.
by substances leaking from the device.
Special attention shall be given to substances which HEARING INSTRUMENTS do not
are carcinogenic, mutagenic or toxic to reproduction, in contain such substances.
accordance with Annex I to Council Directive
67/548/EEC of 27 June 1967 on the approximation of
laws, regulations and administrative provisions relating
to the classification, packaging and labelling of
dangerous substances.
If parts of a device (or a device itself) intended to HEARING INSTRUMENTS are not
administer and/or remove medicines, body liquids or intended to administer medicinal
other substances to or from the body, or devices products.
intended for transport and storage of such body fluids
or substances, contain phthalates which are classified
as carcinogenic, mutagenic or toxic to reproduction, of
category 1 or 2, in accordance with Annex I to Directive
67/548/EEC, these devices must be labelled on the
device itself and/or on the packaging for each unit or,
where appropriate, on the sales packaging as a device
containing phthalates.
If the intended use of such devices includes treatment HEARING INSTRUMENTS are not
of children or treatment of pregnant or nursing women, intended to administer medicinal
the manufacturer must provide a specific justification products.
for the use of these substances with regard to
compliance with the essential requirements, in
particular of this paragraph, within the technical
documentation and, within the instructions for use,
information on residual risks for these patient groups
and, if applicable, on appropriate precautionary
measures.
7.6 Devices must be designed and manufactured in such a Covered in 201.11.6.5
way as to reduce, as much as possible, risks posed by

the unintentional ingress of substances into the device
taking into account the device and the nature of the
environment in which it is intended to be used.
8 Infection and microbial contamination General Guidance note 2 and 3
shall be observed
8.1 The devices and manufacturing processes must be Design covered in 201.12.2,
designed in such a way as to eliminate or reduce as far 201.11.6.6 and instruction covered
as possible the risk of infection to the patient, user and in 201.7.9.2.12.
third parties. The design must allow easy handling and,

where necessary, minimize contamination of the device
by the patient or vice versa during use.
8.2 Tissues of animal origin must originate from animals Not applicable to HEARING
that have been subject to veterinary controls and INSTRUMENTS.
surveillance adapted to the intended use of the tissues.
8.3 Devices delivered in a sterile state must be designed, Not applicable to HEARING
manufactured and packed in a non-reusable pack INSTRUMENTS.
and/or according to appropriate procedures to ensure
that they are sterile when placed on the market and
remain sterile, under the storage and transport
conditions laid down, until the protective packaging is
damaged or opened.
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No. Essential Requirements Coverage of EN 60601-2-66
8.4 Devices delivered in a sterile state must have been Not applicable to HEARING
manufactured and sterilized by an appropriate, INSTRUMENTS.
validated method.
8.5 Devices intended to be sterilized must be Not applicable to HEARING
manufactured in appropriately controlled (e.g. INSTRUMENTS.
environmental) conditions.
8.6 Packaging system for non-sterile devices must keep Aspects of packaging not covered.
the product without deterioration at the level of
cleanliness stipulated and, if the devices are to be
sterilized prior to use, minimize the risk of microbial
contamination;
the packaging system must be suitable taking account Not applicable to HEARING
of the method of sterilization indicated by the INSTRUMENTS.
manufacturer.
8.7 The packaging and/or label of the device must Not applicable to HEARING
distinguish between identical or similar products sold in INSTRUMENTS.
both sterile and non-sterile condition.
9 Construction and environmental properties General Guidance note 2 and 3
shall be observed
9.1 If the device is intended for use in combination with Covered by 201.5.5, 201.7.9.2.5,
other devices or equipment, the whole combination, 201.6.2, 201.7.9.2.9, 201.8.1,
including the connection system must be safe and must 201.8.2.1 and 201.8.4.2 as well as
not impair the specified performances of the devices. the required application of risk and
usability management 4.2,
201.7.1.1, 201.12.2.
Any restrictions on use must be indicated on the label Covered by 201.7.9.2, 201.7.9.2.2
or in the instructions for use. and 201.7.9.3.1.
9.2 Devices must be designed and manufactured in such a
way as to remove or minimize as far as is possible:
– the risk of injury, in connection with their physical There are no risks of injury, in
features, including the volume/pressure ratio, connection with the physical
dimensional and where appropriate ergonomic features, including the
features; volume/pressure ratio, dimensional
and ergonomic features of HEARING
INSTRUMENTS. Mechanical risks are
covered by 201.9.
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No. Essential Requirements Coverage of EN 60601-2-66
– risks connected with reasonably foreseeable The reference to EN 60118-13 in
environmental conditions, such as magnetic fields, 201.17 of this document provides
external electrical influences, electrostatic design and test requirements with
discharge, pressure, temperature or variations in regards to magnetic fields, external
pressure and acceleration; electrical influences, electrostatic
discharges which are suitable to
remove or minimize as far as
possible risks to hearing aids.
201.5.3, 201.5.7, 201.7.2.17,
201.7.9.2.1, 201.7.9.2.2,
201.15.3.7 of this document
provide design and test
requirements with regards to
climatic environmental conditions
which are suitable to remove or
minimize as far as possible risks to
hearing aids from pressure,
temperature or variations in
pressure.
– the risks of reciprocal interference with other The reference to EN 60118-13 in
devices normally used in the investigations or for 201.17 of this document provides
the treatment given; design requirements to remove or
minimize as far as possible risks
connected with reciprocal
interference by EMC phenomena
with other devices.
201.7.9.2.2 contains requirements
for warnings regarding other
potential causes of reciprocal
interference.
– risks arising where maintenance or calibration are HEARING INSTRUMENTS do not need
not possible (as with implants), from ageing of calibration. Maintenance is
materials used or loss of accuracy of any possible. 201.15.2 contains
measuring or control mechanism. requirements with regards to
serviceability.
9.3 Devices must be designed and manufactured in such a Risks of fire and high temperatures
way as to minimize the risks of fire or explosion during covered in 201.11.1.1, 201.13.1.2
normal use and in single fault condition.
The requirements for HEARING
INSTRUMENTS that are intended to
be used in explosive and oxygen-
enriched atmospheres are not
covered in this document.
Particular attention must be paid to devices whose HEARING INSTRUMENTS are normally
intended use includes exposure to flammable not exposed to flammable
substances or to substances which could cause substances or to substances which
combustion. could cause combustion.
The requirements for HEARING
INSTRUMENTS that are intended to
be used in explosive and oxygen-
enriched atmospheres are not
covered in this document.
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No. Essential Requirements Coverage of EN 60601-2-66
10 Devices with a measuring function
10.1 Devices with a measuring function must be designed Not applicable to HEARING
and manufactured in such a way as to provide INSTRUMENTS.
sufficient accuracy and stability within appropriate limits
of accuracy and taking account of the intended purpose
of the device.
The limits of accuracy must be indicated by th
...