EN IEC 60118-13:2020
(Main)Electroacoustics - Hearing aids - Part 13: Requirements and methods of measurement for electromagnetic immunity to mobile digital wireless devices
Electroacoustics - Hearing aids - Part 13: Requirements and methods of measurement for electromagnetic immunity to mobile digital wireless devices
IEC 60118-13:2019 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. IEC 60118-13:2019 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.
Elektroakustik - Hörgeräte - Teil 13: Elektromagnetische Verträglichkeit (EMV), Störfestigkeit gegen digitale Mobilfunkgeräte
Électroacoustique - Appareils de correction auditive - Partie 13: Exigences et méthodes de mesure de l'immunité électromagnétique aux appareils numériques mobiles sans fil
L'IEC 60118-13:2019 s'applique aux phénomènes de compatibilité électromagnétique (CEM) concernant les appareils de correction auditive. L'immunité des appareils de correction auditive aux champs de haute fréquence produits par les appareils numériques sans fil tels que les téléphones mobiles a été identifiée comme l'un des phénomènes de CEM les plus pertinents ayant un impact sur les appareils de correction auditive. L'IEC 60118-13:2019 annule et remplace la quatrième édition parue en 2016, dont elle constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: a) elle introduit une nouvelle méthode de mesure et un ensemble d'exigences de CEM relatives à l'immunité des appareils de correction auditive aux appareils numériques mobiles sans fil; b) les exigences générales CEM pour les appareils de correction auditive ne sont plus incluses (il convient qu'elles soient couvertes par d'autres normes, selon le cas.
Elektroakustika - Slušni pripomočki - 13. del: Zahteve in metode merjenja elektromagnetne odpornosti proti mobilnim digitalnim brezžičnim napravam (IEC 60118-13:2019)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
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
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
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
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
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
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.
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
– 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 .
...
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