Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems (IEC 60601-2-66:2019)

EN-IEC 60601-2-66 applies to the BASIC SAFETY of HEARING AIDS and HEARING AID SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. If a clause or subclause is specifically intended to be applicable to HEARING AIDS only, or to HEARING AID SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to HEARING AIDS and to HEARING AID SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of HEARING AIDS or HEARING AID SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 201.7.9.2 and 201.9.6. ACCESSORIES to HEARING AIDS in the HOME HEALTHCARE ENVIRONMENT (e.g. remote control units, audio streamers, battery chargers, power supplies) can be tested according to the applicable standard, IEC 60065, IEC 60950-1, IEC 62368-1 or other applicable IEC safety standards. Alternatively, the general standard may be applied. HEARING AIDS do not have a MAINS PART intended for connection to AC SUPPLY MAINS. The connection to the SUPPLY MAINS of a HEARING AID SYSTEM is covered by power supply, charger or other types of ACCESSORIES. ACCESSORIES with FUNCTIONAL CONNECTION to a HEARING AID may form a HEARING AID SYSTEM. HEARING AID related ACCESSORIES that are not physically connected to the HEARING AID during NORMAL USE are not considered to be APPLIED PART, because they do not directly contribute to the INTENDED USE of the HEARING AID. Wireless programming interfaces are covered by the applicable standard IEC 60065, IEC 60950-1, IEC 62368-1 or other applicable IEC safety standards. Alternatively, the general standard may be applied. Programming interfaces with wired connection to the HEARING AID are covered by the general standard.

Medizinische elektrische Geräte - Teil 2-66: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Hörgeräten und Hörgerätesystemen (IEC 60601-2-66:2019)

Appareils électromédicaux - Partie 2-66: Exigences particulières pour la sécurité de base et les performances essentielles des instruments d'audition et systèmes d'audition (IEC 60601-2-66:2019)

IEC 60601-2-66:2019 est disponible sous forme de IEC 60601-2-66:2019 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.L'IEC 60601-2-66:2019 s'applique à la SECURITE DE BASE des APPAREILS DE CORRECTION AUDITIVE et des SYSTEMES DE CORRECTION AUDITIVE, également appelés ci-après "APPAREILS EM" ou "SYSTEMES EM". L'IEC 60601-2-66:2019 annule et remplace la deuxième édition parue en 2015. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: a) révision de la définition des PERFORMANCES ESSENTIELLES; b) révision de l'application de l'IEC 60601-1-2:2014 pour les perturbations électromagnétiques; c) correction de la tension utilisée pour les APPAREILS DE CORRECTION AUDITIVE de 1,6 V à 4,5 V; d) correction du niveau d'essai de chute de 1,5 m à 1,0 m; e) correction de la formulation de l'IEC 60601-2-66:2015.

Medicinska električna oprema - 2-66. del: Posebne zahteve za osnovno varnost in bistvene lastnosti slušnih pripomočkov in sistemov (IEC 60601-2-66:2019)

General Information

Status
Published
Publication Date
06-May-2020
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
22-Apr-2020
Due Date
27-Jun-2020
Completion Date
07-May-2020

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SLOVENSKI STANDARD
SIST EN IEC 60601-2-66:2020
01-julij-2020
Nadomešča:
SIST EN 60601-2-66:2016
Medicinska električna oprema - 2-66. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti slušnih pripomočkov in sistemov (IEC 60601-2-66:2019)

Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and

essential performance of hearing aids and hearing aid systems (IEC 60601-2-66:2019)

Medizinische elektrische Geräte - Teil 2-66: Besondere Festlegungen für die Sicherheit

einschließlich der wesentlichen Leistungsmerkmale von Hörgeräten und
Hörgerätesystemen (IEC 60601-2-66:2019)

Appareils électromédicaux - Partie 2-66: Exigences particulières pour la sécurité de base

et les performances essentielles des instruments d'audition et systèmes d'audition (IEC

60601-2-66:2019)
Ta slovenski standard je istoveten z: EN IEC 60601-2-66:2020
ICS:
11.180.15 Pripomočki za gluhe osebe in Aids for deaf and hearing
osebe z okvaro sluha impaired people
SIST EN IEC 60601-2-66:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 60601-2-66:2020
---------------------- Page: 2 ----------------------
SIST EN IEC 60601-2-66:2020
EUROPEAN STANDARD EN IEC 60601-2-66
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2020
ICS 11.180.15; 17.140.50 Supersedes EN 60601-2-66:2015 and all of its
amendments and corrigenda (if any)
English Version
Medical electrical equipment - Part 2-66: Particular requirements
for the basic safety and essential performance of hearing aids
and hearing aid systems
(IEC 60601-2-66:2019)

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 appareils de correction auditive et des wesentlichen Leistungsmerkmale von Hörgeräten und

systèmes de correction auditive Hörgerätesystemen
(IEC 60601-2-66:2019) (IEC 60601-2-66:2019)

This European Standard was approved by CENELEC on 2020-02-19. 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the

Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels

© 2020 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. EN IEC 60601-2-66:2020 E
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SIST EN IEC 60601-2-66:2020
EN IEC 60601-2-66:2020 (E)
European foreword

The text of document 29/1023/FDIS, future edition 3 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 IEC 60601-2-66:2020.
The following dates are fixed:

• latest date by which the document has to be implemented at national (dop) 2020-11-19

level by publication of an identical national standard or by endorsement

• latest date by which the national standards conflicting with the (dow) 2023-02-19

document have to be withdrawn

This document supersedes EN 60601-2-66:2015 and all of its amendments and corrigenda (if any).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CENELEC 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 60601-2-66:2019 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 60601-1-9 NOTE Harmonized as EN 60601-1-9
IEC 60601-1-10 NOTE Harmonized as EN 60601-1-10
IEC 60645-1:2017 NOTE Harmonized as EN 60645-1:2017 (not modified)
IEC 61000-4-2 NOTE Harmonized as EN 61000-4-2
IEC 61000-4-8 NOTE Harmonized as EN 61000-4-8
IEC 62489-1:2010 NOTE Harmonized as EN 62489-1:2010 (not modified)

IEC 62489-1:2010/A1:2014 NOTE Harmonized as EN 62489-1:2010/A1:2015 (not modified)

IEC 62489-1:2010/A2:2017 NOTE Harmonized as EN 62489-1:2010/A2:2018 (not modified)

IEC 62366-1:2015 NOTE Harmonized as EN 62366-1:2015 (not modified)
CISPR 11 NOTE Harmonized as EN 55011
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SIST EN IEC 60601-2-66:2020
EN IEC 60601-2-66:2020 (E)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments)

applies.

NOTE 1 Where 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.
Clause 2 of the general standard applies except as follows:
Replacement:
Publication Year Title EN/HD Year

IEC 60950-1 (mod) 2005 Information technology equipment - Safety EN 60950-1 2006

- Part 1: General requirements
- - + A11 2009
+ A1 (mod) 2009 + A1 2010
- - + A12 2011
+ A2 (mod) 2013 + A2 2013
IEC 62368-1 (mod) 2014 Audio/video, information and EN 62368-1 2014
communication technology equipment -
Part 1: Safety requirements
- - + A11 2017
Addition:
Publication Year Title EN/HD Year
IEC 60118-0 2015 Electroacoustics - Hearing aids - Part 0: EN 60118-0 2015
Measurement of the performance
characteristics of hearing aids
IEC 60118-13 - Electroacoustics - Hearing aids - Part 13: EN 60118-13 2019
Electromagnetic compatibility (EMC)
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
+ A1 2012 + A1 2013
- - + A12 2014
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SIST EN IEC 60601-2-66:2020
EN IEC 60601-2-66:2020 (E)
Publication Year Title EN/HD Year
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests

IEC 60601-1-11 2015 Medical electrical equipment - Part 1-11: EN 60601-1-11 2015

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 2006
cycle processes
+ A1 2015
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SIST EN IEC 60601-2-66:2020
EN IEC 60601-2-66:2020 (E)
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives

This European standard has been prepared under a Commission’s standardisation request M/023 and

M432 concerning the development of European Standards related to medical devices 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 AIDS and HEARING AID 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 IEC 60601-2-66:2020
EN IEC 60601-2-66:2020 (E)
Table ZZ.1 – Relationship between Essential Requirements of Directive 93/42/EEC
amended by 2007/47/EC, and clauses and subclauses of this standard
Remarks/Notes
Essential Requirements of Clause(s)/sub-
Directive 93/42/EEC clause(s) of this EN
201.7.9.1
1, second indent This document (201.7.9.1, 201.7.9.2.1,
201.7.9.2.1
201.7.9.2.2) covers requirements related to
201.7.9.2.2
instructions for use, including safety
warnings and notices by considering the
technical knowledge, experience, education
and training and where applicable the
medical and physical conditions of intended
users (design for lay, professional, disabled
or other users).
201.7.2.17
5 Covered by requirements to design and
201.7.9.2.2
packaging (201.7.2.17) to withstand
201.15.3
transport and storage with regards of
201.15.3.7
mechanical strength (201.15.3), resistance
to environmental conditions (201.15.3.7) and
the necessary instructions (201.7.9.2.2).
201.7.9.2.1
6 The reduction of unintentional exposure to
201.9.6
excessive acoustic noise is covered in
201.9.6 regarding the design.
201.7.9.2.1 covers information and
instructions for the user related to side
effects.
201.11.1.1
7.1, first indent Covered for risks of fire and high
201.13.1.2
temperatures.
201.11.6.6
7.3 This document covers (201.15.3.7,
201.15.3.7
201.11.6.6) the design of devices in such a
way that they can be used safely with the
materials, substances and gases with which
they enter into contact during their normal
use or during routine procedures.
Requirements for HEARING AIDS that are
intended to be used in explosive and
oxygenenriched atmospheres are not
contained in this standard (see 201.11.2).

7.5, first sentence of first 201.7.9.2.4 Covered for the risk of leakage from the

paragraph only battery in situ.
7.6 201.11.6.5 Covered in 201.11.6.5.
8.1, first sentence only 201.7.9.2.12 Design covered in 201.12.2, 201.11.6.6 and
instruction covered in 201.7.9.2.12.
201.11.6.6
201.12.2
9.1 201.5.5 c)
201.6.2
201.7.9.2.5
201.7.9.2.9
201.8.1
201.8.2.1
201.8.4.2
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SIST EN IEC 60601-2-66:2020
EN IEC 60601-2-66:2020 (E)
Remarks/Notes
Essential Requirements of Clause(s)/sub-
Directive 93/42/EEC clause(s) of this EN
9.2, first indent 201.9 Mechanical risks (e.g. ‘entanglement’) are
covered by 201.9.
9.2, second indent 201.5.3 Covered in respect of environmental
temperatures, humidity or variations in
201.5.7
pressure: 201.5.3, 201.5.7, 201.7.2.17,
201.7.2.17
201.7.9.2.1, 201.7.9.2.2, 201.15.3.7 of this
201.7.9.2.1
document provide design and test
201.7.9.2.2 requirements with regards to climatic
environmental conditions which are suitable
201.15.3.7
to remove or minimize as far as possible
these risks.
9.2, third indent 201.7.9.2.2 To fully cover this ER, risks must be
removed or minimised as far as possible.
201.17
Covered for the serviceability of hearing aids
9.2, fourth indent 201.15.2
subject to mechanical wear, electrical
degradation or ageing.
9.3 201.11.1.1 Risks of fire and high temperatures covered
in 201.11.1.1, 201.13.1.2.
201.13.1.2
HEARING AIDS are normally not exposed to
flammable substances or to substances
which could cause combustion.
The requirements for HEARING AIDS that
are intended to be used in explosive and
oxygenenriched atmospheres are not
covered in this document.
12.5 201.17 To fully cover this ER, risks must be
removed or minimised as far as possible.
12.6 201.8 Electrical risks covered in 201.8 for normal
conditions and 201.13 in fault conditions.
201.13
12.7.1 201.15.3.1 Covered by the mechanical requirements in
201.15.3.1.
12.7.3 201.7 The reduction of unintentional exposure to
excessive acoustic noise is covered in
201.9.6
201.9.6 regarding the design, in 201.7
201.13.1.2
regarding correct application 201.13.1.2 in
case of faults.
12.7.4 201.8.1 Covered in respect of the following: Electrical
Risks:
201.8.2.1
201.8.1 Fundamental rule of protection
201.8.7
against electric shock
201.16
201.8.2.1 Connection to power sources
201.16 Limitation of voltage current or
energy 201.8.7 Leakage current. Gas or
hydraulic and pneumatic energy supplies not
applicable to HEARING AIDS.
12.7.5 201.11.1 Covered by 201.11.1 Excessive
temperatures
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SIST EN IEC 60601-2-66:2020
EN IEC 60601-2-66:2020 (E)
Remarks/Notes
Essential Requirements of Clause(s)/sub-
Directive 93/42/EEC clause(s) of this EN
12.8.1 201.9.6 Requirements of sufficient accurate
indication of output is covered in 201.9.6.
201.12.4.4
201.12.4.4 covers possible sources of
incorrect output.
12.8.2 201.9.6 The reduction of unintentional exposure to
excessive acoustic noise is covered in
201.9.6
12.9 201.7.9.1 Requirements to specification of function of
controls and indicators on the device or in
201.7.9.2.1
the instructions for use are covered in
201.7.9.2.9
201.7.9.2.1 and 201.7.9.2.9.
13.1 – first and second 201.7.9.2 Covered in respect of the following:
201.7.9.2 Instructions for use. 201.7.9.2.16
paragraph 201.7.9.2.16
Technical description, provided that the
technical description is included in the
instructions for use.

13.1 - first and third paragraph 201.7.2.2 Covered in respect of information on the

packaging in 201.7.2.17. Covered in respect
201.7.2.17
of information in the instruction for use in
201.7.9.2
201.7.9.2.

13.1 - first and fourth paragraph 201.7.9.2 Requirements for instruction for use covered

in 201.7.9.2.
13.2 201.7.8.1 Description of symbols in the documentation
covered in 201.7.9.2.9. Description of
201.7.9.2.9
colours in the documentation covered in
201.7.8.1.
13.3 a) 201.7.2.2 To fully cover this ER, the name and address
of the authorised representative must be
provided, if applicable.
13.3 d) 201.7.2.2 To fully cover this ER the batch number (if
provided) must be preceded by the symbol
LOT.
13.3 i) 201.7.2.17
13.3 j) 201.7.2
13.3 l) 201.7.2.2
13.4 201.7.9.1 Covered for the Instructions for Use.
13.5 201.7.2.2 Serial number required in 201.7.2.2.
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SIST EN IEC 60601-2-66:2020
EN IEC 60601-2-66:2020 (E)
Remarks/Notes
Essential Requirements of Clause(s)/sub-
Directive 93/42/EEC clause(s) of this EN
13.6 b) 201.7.9.3 Covered provided the technical description is
included in the instructions for use.
13.6 d) 201.7.9.2.1
201.7.9.2.12
13.6 k) 201.7.9.2.1
13.6 l) 201.7.9.2.1

WARNING 1 — Presumption of conformity stays valid only as long as a reference to this

European Standard is maintained in the list published in the Official Journal of the European

Union. Users of this standard should consult frequently the latest list published in the Official

Journal of the European Union.

WARNING 2 — Other Union legislation may be applicable to the products falling within the

scope of this standard.
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SIST EN IEC 60601-2-66:2020
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SIST EN IEC 60601-2-66:2020
IEC 60601-2-66
Edition 3.0 2019-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-66: Particular requirements for the basic safety and essential
performance of hearing aids and hearing aid systems
Appareils électromédicaux –
Partie 2-66: Exigences particulières pour la sécurité de base et les
performances essentielles des appareils de correction auditive et des systèmes
de correction auditive
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.180.15; 17.140.50 ISBN 978-2-8322-7350-0

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

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

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
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SIST EN IEC 60601-2-66:2020
– 2 – IEC 60601-2-66:2019 © IEC 2019
CONTENTS

FOREWORD ........................................................................................................................... 4

INTRODUCTION ..................................................................................................................... 7

201.1 Scope, object and related standards ....................................................................... 8

201.2 Normative references ............................................................................................ 10

201.3 Terms and definitions ............................................................................................ 11

201.4 General requirements ........................................................................................... 12

201.5 General requirements for testing ME EQUIPMENT .................................................... 13

201.6 Classification of ME EQUIPMENT and ME SYSTEMS .................................................... 15

201.7 ME EQUIPMENT identification, marking and documents ........................................... 15

201.8 * Protection against electrical HAZARDS from ME EQUIPMENT ................................... 21

201.9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS ......... 23

201.10 * Protection against unwanted and excessive radiation HAZARDS ........................... 25

201.11 * Protection against excessive temperatures and other HAZARDS ........................... 25

201.12 * Accuracy of controls and instruments and protection against hazardous

outputs.................................................................................................................. 27

201.13 * HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT ............................. 28

201.14 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .......................................... 30

201.15 * Construction of ME EQUIPMENT ............................................................................. 31

201.16 * ME SYSTEMS ........................................................................................................ 33

201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS ........................... 33

Annexes ............................................................................................................................... 35

Annex E (informative) Examples of the connection of the measuring device (MD) for

measurement of the PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT ................... 36

Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic

mixtures ................................................................................................................................ 37

Annex H (informative) PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE and

documentation ...................................................................................................................... 38

Annex I (informative) ME SYSTEMS aspects ........................................................................... 39

Annex J (informative) Survey of insulation paths .................................................................. 40

Annex K (informative) Simplified PATIENT LEAKAGE CURRENT diagrams .................................. 41

Annex L (normative) Insulated winding wires for use without interleaved insulation .............. 42

Annex AA (informative) Particular guidance and rationale .................................................... 43

Annex BB (informative) Abbreviations .................................................................................. 48

Annex CC (informative) Essential performance .................................................................... 49

Annex DD (informative) Electromagnetic compatibility of ME EQUIPMENT ............................... 50

Bibliography .......................................................................................................................... 52

Index of defined terms used in this particular standard .......................................................... 54

Figure 201.101 – Measuring circuit for LEAKAGE CURRENT (see 201.8.7.4.7) .......................... 22

Table 201.101 – MECHANICAL HAZARDS to be considered ....................................................... 24

Table AA.101 – Summary of the approach of this document ................................................. 44

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SIST EN IEC 60601-2-66:2020
IEC 60601-2-66:2019 © IEC 2019 – 3 –

Table DD.101 – Example of applicable standards for HEARING AID specific setting for

RF radiated emissions .......................................................................................................... 50

Table DD.102 – Example of applicable tests ......................................................................... 51

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SIST EN IEC 60601-2-66:2020
– 4 – IEC 60601-2-66:2019 © IEC 2019
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-66: Particular requirements for the basic safety and essential
performance of hearing aids and hearing aid systems
FOREWORD

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6) All users should ensure that they have the latest edition of this publication.

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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 third edition cancels and replaces the second edition published in 2015. It constitutes a

technical revision.

This edition includes the following significant technical changes with respect to the previous

edition:
a) revision of the definition about ESSENTIAL PERFORMANCE;

b) revision of the application of IEC 60601-1-2:2014 for electromagnetic disturbances;

c) correction of the used voltage for HEARING AIDS from 1,6 V to 4,5 V;
d) correction of the drop test level from 1,5 m to 1,0 m;
e) correction of the wording of IEC 60601-2-66:2015.
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SIST EN IEC 60601-2-66:2020
IEC 60601-2-66:2019 © IEC 2019 – 5 –
The text of this International Standard is based on the following documents:
FDIS Report on voting
29/1023/FDIS 29/1030/RVD

Full information on the voting for the approval of this International Standard can be found in the

report on voting indicated in the above table.

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

In this document, the following print types are used:
– requirements and definitions: roman type;
– test specifications: italic type;
informative material appearing outside of tables, such as notes, exa
...

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