SIST EN IEC 60118-13:2020

SLOVENSKI STANDARD
SIST EN IEC 60118-13:2020
01-junij-2020
Nadomešča:
SIST EN 60118-13:2011
Elektroakustika - Slušni pripomočki - 13. del: Zahteve in metode merjenja
elektromagnetne odpornosti proti mobilnim digitalnim brezžičnim napravam (IEC
60118-13:2019)
Electroacoustics - Hearing aids - Part 13: Requirements and methods of measurement
for electromagnetic immunity to mobile digital wireless devices (IEC 60118-13:2019)
Elektroakustik - Hörgeräte - Teil 13: Elektromagnetische Verträglichkeit (EMV),
Störfestigkeit gegen digitale Mobilfunkgeräte (IEC 60118-13:2019)
Électroacoustique - Appareils de correction auditive - Partie 13: Exigences et méthodes
de mesure de l'immunité électromagnétique aux appareils numériques mobiles sans fil
(IEC 60118-13:2019)
Ta slovenski standard je istoveten z: EN IEC 60118-13:2020
ICS:
11.180.15 Pripomočki za gluhe osebe in Aids for deaf and hearing
osebe z okvaro sluha impaired people
17.140.50 Elektroakustika Electroacoustics
33.100.20 Imunost Immunity
SIST EN IEC 60118-13:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 60118-13:2020

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SIST EN IEC 60118-13:2020


EUROPEAN STANDARD EN IEC 60118-13

NORME EUROPÉENNE

EUROPÄISCHE NORM
April 2020
Supersedes EN 60118-13:2011 and all of its amendments
ICS 17.140.50; 33.100.20
and corrigenda (if any)
English Version
Electroacoustics - Hearing aids - Part 13: Requirements and
methods of measurement for electromagnetic immunity to mobile
digital wireless devices
(IEC 60118-13:2019)
Électroacoustique - Appareils de correction auditive - Partie Elektroakustik - Hörgeräte - Teil 13: Elektromagnetische
13: Exigences et méthodes de mesure de l'immunité Verträglichkeit (EMV), Störfestigkeit gegen digitale
électromagnétique aux appareils numériques mobiles sans Mobilfunkgeräte
fil (IEC 60118-13:2019)
(IEC 60118-13:2019)
This European Standard was approved by CENELEC on 2019-12-03. 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 60118-13:2020 E

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SIST EN IEC 60118-13:2020
EN IEC 60118-13:2020 (E)
European foreword
The text of document 29/1024/FDIS, future edition 5 of IEC 60118-13, prepared by IEC/TC 29
"Electroacoustics" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
EN IEC 60118-13:2020.
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 60118-13:2011 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 60118-13:2019 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 NOTE Harmonized as EN 60118-4
IEC 60118-7 NOTE Harmonized as EN 60118-7
IEC 60118-15 NOTE Harmonized as EN 60118-15
IEC 60601-1-2 NOTE Harmonized as EN 60601-1-2
IEC 61000-4-2 NOTE Harmonized as EN 61000-4-2
IEC 61000-4-8 NOTE Harmonized as EN 61000-4-8
IEC 60601-2-66 NOTE Harmonized as EN 60601-2-66
CISPR 11 NOTE Harmonized as EN 55011


2

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SIST EN IEC 60118-13:2020
EN IEC 60118-13:2020 (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.
Publication Year Title EN/HD Year
IEC 60118-0 2015 Electroacoustics - Hearing aids - EN 60118-0 2015
Part 0: Measurement of the performance
characteristics of hearing aids
IEC 60318-5 Electroacoustics - Simulators of human EN 60318-5 2006
3
head and ear - Part 5: 2 cm coupler for
the measurement of hearing aids and
earphones coupled to the ear by means of
ear inserts
IEC 61000-4-3 Electromagnetic compatibility (EMC) - EN 61000-4-3 2006
Part 4-3: Testing and measurement
 + A1 2008
techniques - Radiated, radio-frequency,
electromagnetic field immunity test
+ A2 2010
IEC 61000-4-20 Electromagnetic compatibility (EMC) - EN 61000-4-20 2010
Part 4-20: Testing and measurement
techniques - Emission and immunity
testing in transverse electromagnetic
(TEM) waveguides

3

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SIST EN IEC 60118-13:2020
EN IEC 60118-13:2020 (E)
Annex ZZ
(informative)

Relationship between this European Standard and the essential requirements
of Directive 93/42/EEC [1993 OJ L 169] aimed to be covered
This European Standard has been prepared under a Commission’s standardization request M/023
concerning the development of European Standards related to medical devices to provide one
voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June
1993 concerning medical devices [1993 OJ L 160].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding essential requirements
of that Directive and associated EFTA regulations.
NOTE 1 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 with Directive 93/42/EEC as 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 2 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 3 This Annex ZZ is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZZ.1, it means that it is not addressed by
this European Standard.
Table ZZ.1 — Correspondence between this European Standard and
Annex I of Directive 93/42/EEC [1993 OJ L 169]
Clause(s)/sub-clause(s) Remarks/Notes
Essential Requirements of
of this EN
Directive 93/42/EEC
5, 6 These clauses specify requirements and
3
test methods to verify the immunity of
the device to radiated electromagnetic
fields from mobile phones. Design
manufacturing and packaging are not
covered.
5 Covered for the use of a hearing aid in
9.1, first sentence only
combination with a mobile phone with
regards to radiated electromagnetic
fields.
5 Covered with regards to immunity to
9.2, second indent
radiated electromagnetic fields from
mobile phones.
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.
4

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SIST EN IEC 60118-13:2020




IEC 60118-13

®


Edition 5.0 2019-10




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE
colour

inside










Electroacoustics – Hearing aids –

Part 13: Requirements and methods of measurement for electromagnetic

immunity to mobile digital wireless devices




Électroacoustique – Appareils de correction auditive–

Partie 13: Exigences et méthodes de mesure de l'immunité électromagnétique


aux appareils numériques mobiles sans fil













INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE


INTERNATIONALE




ICS 17.140.50; 33.100.20 ISBN 978-2-8322-7330-2




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 60118-13:2020
– 2 – IEC 60118-13:2019 © IEC 2019
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Operation and function of the hearing aid . 8
5 Requirements for electromagnetic immunity. 8
5.1 General . 8
5.2 Compliance criteria . 9
6 Test procedures for immunity to radiated RF electromagnetic fields . 11
6.1 General . 11
6.2 Test setup . 11
6.3 Hearing aid test setting . 11
6.4 Determination of gain . 12
6.5 Measurement of the input related ambient noise (IRAN) . 12
6.6 Hearing aid output coupling during immunity test . 13
6.7 Position of the hearing aid during immunity test . 13
6.8 Measurement of the output related interference level (ORIL) . 14
6.9 Calculation of the input related interference level (IRIL) . 15
6.10 Report. 15
7 Measurement uncertainty for immunity to radiated RF electromagnetic fields . 16
Annex A (informative) Background for establishing test methods, performance criteria
and test levels . 17
A.1 General . 17
A.2 Radiated RF electromagnetic fields – History of the test method . 17
A.3 Performance criteria . 19
A.4 Test field strengths – Bystander compatibility . 19
A.5 Test field strengths – User compatibility . 20
Bibliography . 21

Figure 1 – Example of a test arrangement for hearing aid immunity measurements
using a GTEM cell . 11
Figure 2 – Examples of input-output response curves at 1 kHz and the determination
of gain at an input SPL of 55 dB . 12
Figure 3 – Hearing aid test positions for BTE (upper) and ITE (lower) . 14
Figure A.1 – Ratio of 1:2 between field strength and interference level in dB . 18
Figure A.2 – Example of test arrangement for hearing aid immunity measurements
using dipole antenna . 20

Table 1 – Field strengths of RF test signals to be used to establish immunity for
bystander compatible and user compatible hearing aids . 10

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IEC 60118-13:2019 © IEC 2019 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

ELECTROACOUSTICS –
HEARING AIDS –

Part 13: Requirements and methods of measurement
for electromagnetic immunity to mobile digital wireless devices

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 60118-13 has been prepared by IEC technical committee 29:
Electroacoustics.
This fifth edition cancels and replaces the fourth edition published in 2016 and constitutes a
technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) it introduces a new measurement method and set of EMC requirements for hearing aids
immunity to mobile digital wireless devices;
b) generic EMC requirements for hearing aids are no longer included – should be covered by
other standards as appropriate.

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SIST EN IEC 60118-13:2020
– 4 – IEC 60118-13:2019 © IEC 2019
The text of this International Standard is based on the following documents:
FDIS Report on voting
29/1024/FDIS 29/1031/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.
A list of all parts in the IEC 60118 series, published under the general title Electroacoustics –
Hearing aids, can be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.

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IEC 60118-13:2019 © IEC 2019 – 5 –
INTRODUCTION
This part of IEC 60118 specifies methods of measurement and requirements for hearing aid
immunity to digital wireless devices. Most hearing aids contain digital signal processors and
some can contain wireless transceivers.
Experience in connection with the use of hearing aids in recent times has identified digital
wireless devices, such as wireless telephones and GSM mobile phones, as potential sources
of disturbance for hearing aids. Interference in hearing aids depends on the emitted power
from the digital wireless device as well as the immunity of the hearing aid. The performance
criteria in this document will not totally ensure hearing aid users' interference- and noise-free
use of wireless telephones, but will establish useable conditions in most situations.
In practice, a hearing aid user, when using a wireless telephone, will seek, if possible, to find
a position on the ear, which gives minimum or no interference in the hearing aid. Various test
methods have been considered for determining the immunity of hearing aids. When a digital
wireless device is used close to a hearing aid, there is an RF near-field illumination of the
hearing aid. However, validation investigations in preparing this document have shown that it
is possible to establish a correlation between the measured far-field immunity level and the
immunity level experienced by an actual hearing aid used in conjunction with a digital wireless
device. The use of a far-field test has shown high reproducibility and is considered sufficient
to verify and express the immunity of hearing aids. Near-field illumination of the hearing aid
(i.e. by generating an RF field using a dipole antenna) could however provide valuable
information during the design and development of hearing aids.
It is recognized that the new wireless products introduced have to coexist with existing
spectra, potential networks and other wireless products (medical as well as non-medical).
This revision does not address the issue of coexistence, and the user of this document shall
consult applicable entities for guidance.
In this fifth edition of IEC 60118-13, the field strengths and hearing aid positioning during
1
measurements have been updated for consistency with IEEE C63.19 [1] and
ANSI C63.19 [2]. The field strength levels used since the first edition of IEC 60118-13 was
published in 1997 have demonstrated, through measurements of more than 1 000 hearing aid
models (ref. European Hearing Instrument Manufacturers Association – EHIMA), to be
sufficiently high to ensure well-functioning hearing aids in everyday use, with only a small
expectation of a few complaints regarding interference from digital wireless devices.
Hearing aids where the outputs are non-acoustic, for example bone conduction hearing aids,
are not directly included in this document, but this document can be used if precise
descriptions of measurement setups for these types of hearing aids are given by the
manufacturer.


___________
1
 Numbers in square brackets refer to the Bibliography

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ELECTROACOUSTICS –
HEARING AIDS –

Part 13: Requirements and methods of measurement
for electromagnetic immunity to mobile digital wireless devices



1 Scope
This part of IEC 60118 covers the relevant EMC phenomena for hearing aids. Hearing aid
immunity to high frequency fields originating from digital wireless devices such as mobile
phones was identified as one of the most relevant EMC phenomena impacting hearing aids.
2 Normative references
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.
IEC 60118-0:2015, Electroacoustics – Hearing aids – Part 0: Measurement of the
performance characteristics of hearing aids
3
IEC 60318-5, Electroacoustics – Simulators of human head and ear – Part 5: 2 cm coupler
for the measurement of hearing aids and earphones coupled to the ear by means of ear
inserts
IEC 61000-4-3, Electromagnetic compatibility (EMC) – Part 4-3: Testing and measurement
techniques – Radiated, radio-frequency, electromagnetic field immunity test
IEC 61000-4-20, Electromagnetic compatibility (EMC) – Part 4-20: Testing and measurement
techniques – Emission and immunity testing in transverse electromagnetic (TEM) waveguides
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1
hearing aid
wearable instrument intended to aid a person with impaired hearing, usually consisting of a
microphone, amplifier, signal processor and earphone, powered by a low-voltage battery, and
possibly also containing an induction pick-up coil and which is fitted using audiometric and
prescriptive methods
Note 1 to entry: Hearing aids can be placed on the body (BW), behind the ear (BTE), in the ear (ITE) or in the
canal (ITC).

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IEC 60118-13:2019 © IEC 2019 – 7 –
3.2
bystander compatibility
immunity of a hearing aid that ensures it is usable in environments where digital wireless
devices are in operation in the proximity of the hearing aid wearer
3.3
user compatibility
immunity of a hearing aid that ensures that it is usable when the wearer is using a digital
wireless device at the wearer's own aided ear
3.4
gain
G
difference between the acoustic or the magnetic equivalent input level (L ) and the
p,in
respective acoustic output level (L )
p,out
Note 1 to entry: The gain is determined at an acoustic input sound pressure level (SPL) of 55 dB or (for induction
pick-up coils) at a magnetic field strength level re 1 A/m of −35 dB which is the magnetic equivalent of 55 dB
(SPL).
Note 2 to entry: G = L – L .

p,out p,in
Note 3 to entry: If not stated otherwise in this document, gain is determined at a frequency of 1 kHz.
3.5
output related interference level
ORIL
sound pressure level at the output of the hearing aid during exposure to a 1 kHz 80 %
amplitude modulated RF signal with time weighting FAST
Note 1 to entry: ORIL = L at 1 kHz, 80 % AM RF.
p, out
Note 2 to entry: This note applies to the French language only.
3.6
input related interference level
IRIL
ORIL with gain (G) subtracted:
IRIL = ORIL − G
Note 1 to entry: IRIL is used to characterize the immunity of a hearing aid.
Note 2 to entry: This note applies to the French language only.
3.7
input related ambient noise
IRAN
equivalent acoustic input sound pressure level that would lead to the acoustic noise output
produced by a hearing aid:
IRAN = ORIL − G
RF off
and
ORIL = L , RF switched off
RF off p, out
Note 1 to entry: IRAN is determined in the same way as IRIL but with the RF signal switched off.
Note 2 to entry: This note applies to the French language only.

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3.8
GSM
global system for mobile communication
Note 1 to entry: This note applies to the French language only.
3.9
TEM cell
closed measuring device in which a voltage difference creates a TEM-mode electromagnetic
field
3.10
GTEM cell
TEM cell that has been altered to extend the usable frequency range
3.11
radio frequency
RF
frequency of electromagnetic radiation within the range of 30 kHz to 30 GHz
Note 1 to entry: This note applies to the French language only.
3.12
microphone mode
hearing aid omnidirectional setting active
3.13
induction pick-up coil mode
hearing aid induction pick-up coil active
3.14
directional mode
hearing aid directional setting active
4 Operation and function of the hearing aid
Hearing aids basically consist of a microphone, an amplifier, an optional induction pick-up coil
and a small earphone (receiver). For behind the ear (BTE) hearing aids, the sound is often fed
to the ear canal by means of an individually made ear mould (ear insert), or with the receiver
in the auditory canal (RITE). In the ear (ITE) and in the canal (ITC) hearing aids, have the
active circuitry l
...