EN 60118-13:2011

Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC)

IEC 60118-13:2011 in principle covers all relevant EMC phenomena for hearing aids. Hearing aid immunity to high frequency electromagnetic fields originating from digital wireless devices operating in the frequency ranges 0,8 GHz to 0,96 GHz and 1,4 GHz to 2,48 GHz is currently identified as the only relevant EMC phenomenon regarding hearing aids. Future editions of this part of IEC 60118 may add tests for other frequency bands, as they come into more common use. IEC 61000-4-3 is the basis for relevant EMC tests to be conducted on hearing aids. Measurement methods and acceptance levels are described in this part of IEC 60118. This third edition cancels and replaces the second edition published in 2004 and constitutes a technical revision. It introduces a new set of requirements for use of hearing aids with mobile phones.

Akustik - Hörgeräte - Teil 13: Elektromagnetische Verträglichkeit (EMV)

Electroacoustique - Appareils de correction auditive - Partie 13: Compatibilité électromagnétique (CEM)

La CEI 60118-13:2011 s'applique en principe à tous les phénomènes de compatibilité électromagnétique (CEM) concernant les appareils de correction auditive. L'immunité des appareils de correction auditive aux champs électromagnétiques de haute fréquence produits par les appareils numériques sans fil fonctionnant dans les plages de fréquences comprises entre 0,8 GHz et 0,96 GHz et entre 1,4 GHz et 2,48 GHz est actuellement identifiée comme le seul phénomène de CEM qui concerne les appareils de correction auditive. On pourra, dans les futures éditions de cette partie de la CEI 60118, ajouter des essais concernant d'autres bandes de fréquences qui deviennent de plus en plus d'usage courant. Les essais de CEM effectués sur les appareils de correction auditive sont fondés sur la CEI 61000-4-3. Les méthodes de mesure et les niveaux d'acceptation sont décrits dans la présente Norme. Cette troisième édition annule et remplace la deuxième édition parue en 2004 et constitue une révision technique. Elle introduit un ensemble d'exigences concernant l'utilisation des appareils de correction auditive avec les téléphones mobiles.

Elektroakustika - Slušni pripomočki - 13. del: Elektromagnetna združljivost (EMC)

Ta del IEC 60118 načelno zajema vse pomembne pojave elektromagnetne združljivosti pri slušnih pripomočkih. Pojavi EMC, kot so radiofrekvenčne emisije in elektrostatična razelektritev, trenutno ne veljajo za pomemben problem v povezavi s slušnimi pripomočki in zato niso obravnavani. Na podlagi novega znanja bodo morda obravnavani v povezavi s prihodnjimi revizijami ali razširitvami tega standarda. Imunost slušnih pripomočkov na visokofrekvenčna elektromagnetna polja, ki izhajajo iz digitalnih brezžičnih naprav, delujočih v frekvenčnem razponu med 0,8 GHz in 0,96 GHz ter med 1,4 GHz in 2,48 GHz, je trenutno znana kot edini pomemben pojav EMC v zvezi s slušnimi pripomočki. V prihodnjih izdajah tega dela IEC 60118 bodo lahko dodani preskusi za druge frekvenčne pasove, ko bodo prišli v splošnejšo uporabo. IEC 61000-4-3 je osnova za ustrezne preskuse EMC, ki se opravljajo na slušnih pripomočkih. Metode merjenja in ravni sprejemljivosti so opisane v tem delu IEC 60118. Za namen tega dela IEC 60118 sta opredeljena dva razreda imunosti slušnih pripomočkov (glej 3.1), ki se nanašata na njihovo uporabo. »Združljivost prisotnosti« zagotavlja, da je slušni pripomoček uporaben v okoljih, kjer v bližini uporabnika slušnega pripomočka delujejo digitalne brezžične naprave. »Uporabniško združljivi« slušni pripomočki zagotavljajo, da je slušni pripomoček uporaben, ko uporabnik uporablja digitalno brezžično napravo v lastnem ušesu, v katerem je pripomoček. Ta standard ne navaja metod merjenja za slušne pripomočke z neakustičnimi izhodnimi signali in slušne pripomočke, ki so s kabli povezani z drugo opremo.

General Information

• Status: Withdrawn
• Publication Date: 04-Aug-2011
• Withdrawal Date: 15-May-2014
• ICS: 17.140.50 - Electroacoustics
• ICS: 33.100.20 - Immunity
• Technical Committee: CLC/SR 29 - Electroacoustics
• Drafting Committee: IEC/TC 29 - IEC_TC_29
• Parallel Committee: IEC/TC 29 - IEC_TC_29
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 28-Apr-2020
• Completion Date: 28-Apr-2020
• Directive: 2004/108/EU - DIRECTIVE 2004/108/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 60118-13:2011 - Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC)

Relations

• Replaces: EN 60118-13:2005 - Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC)
• Effective Date: 28-Jan-2023
• Replaced By: EN IEC 60118-13:2020 - Electroacoustics - Hearing aids - Part 13: Requirements and methods of measurement for electromagnetic immunity to mobile digital wireless devices
• Effective Date: 07-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2011
(OHNWURDNXVWLND6OXãQLSULSRPRþNLGHO(OHNWURPDJQHWQD]GUXåOMLYRVW(0&
Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC)
Akustik - Hörgeräte - Teil 13: Elektromagnetische Verträglichkeit (EMV)
Electroacoustique - Appareils de correction auditive - Partie 13: Compatibilité
électromagnétique (CEM)
Ta slovenski standard je istoveten z: EN 60118-13:2011
ICS:
11.180.15 3ULSRPRþNL]DJOXKHRVHEHLQ Aids for deaf and hearing
RVHEH]RNYDURVOXKD impaired people
33.100.01 Elektromagnetna združljivost Electromagnetic compatibility
na splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 60118-13
NORME EUROPÉENNE
August 2011
EUROPÄISCHE NORM
ICS 17.140.50; 33.100.20 Supersedes EN 60118-13:2005

English version
Electroacoustics -
Hearing aids -
Part 13: Electromagnetic compatibility (EMC)
(IEC 60118-13:2011)
Electroacoustique -  Akustik -
Appareils de correction auditive - Hörgeräte -
Partie 13: Compatibilité électromagnétique Teil 13: Elektromagnetische
(CEM) Verträglichkeit (EMV)
(CEI 60118-13:2011) (IEC 60118-13:2011)

This European Standard was approved by CENELEC on 2011-05-16. 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 Central Secretariat 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 Central Secretariat 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, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels

© 2011 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60118-13:2011 E
Foreword
The text of document 29/737/FDIS, future edition 3 of IEC 60118-13, prepared by IEC TC 29,
Electroacoustics, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as
EN 60118-13 on 2011-05-16.
This European Standard supersedes EN 60118-13:2005.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent
rights.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2012-02-16
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2014-05-16
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive MDD (93/42/EEC). See Annex ZZ.
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60118-13:2011 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standard indicated:
IEC 60118-4 NOTE  Harmonized as EN 60118-4.
__________
- 3 - EN 60118-13:2011
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following referenced documents are indispensable for the application 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  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Publication Year Title EN/HD Year

IEC 60118-0 - Hearing aids - EN 60118-0 -
Part 0: Measurement of electroacoustical
characteristics
IEC 60118-2 - Hearing aids - EN 60118-2 -
Part 2: Hearing aids with automatic gain
control circuits
IEC 60118-7 - Electroacoustics - Hearing aids - EN 60118-7 -
Part 7: Measurement of the performance
characteristics of hearing aids for production,
supply and delivery quality assurance
purposes
IEC 60318-4 - Electroacoustics - Simulators of human head EN 60318-4 -
and ear -
Part 4: Occluded-ear simulator for the
measurement of earphones coupled to the ear
by means of ear inserts
IEC 60318-5 - Electroacoustics - Simulators of human head EN 60318-5 -
and ear -
Part 5: 2 cm³ 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 -
Part 4-3: Testing and measurement
techniques - Radiated, radio-frequency,
electromagnetic field immunity test

IEC 61000-4-20 - Electromagnetic compatibility (EMC) - EN 61000-4-20 -
Part 4-20: Testing and measurement
techniques - Emission and immunity testing in
transverse electromagnetic (TEM)
waveguides
Annex ZZ
(informative)
Coverage of Essential Requirements of EC Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers only the
following essential requirements out of those given in Annex I of the EC Directive 93/42/EEC:
– ER 3, only for the aspect of electromagnetic compatibility for performance.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
IEC 60118-13 ®
Edition 3.0 2011-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Electroacoustics – Hearing aids –
Part 13: Electromagnetic compatibility (EMC)

Électroacoustique – Appareils de correction auditive –
Partie 13: Compatibilité électromagnétique (CEM)

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX S
ICS 17.140.50; 33.100.20 ISBN 978-2-88912-456-5

– 2 – 60118-13  IEC:2011
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 8
4 Requirements for immunity . 9
5 Immunity test procedures . 10
6 Measurement uncertainty . 13
Annex A (informative) Background for establishing test methods, performance criteria
and test levels . 15
Bibliography . 20

Figure 1 – Example of a test arrangement for hearing aid immunity measurements
using a one-port TEM cell (asymmetric septum) . 11
Figure 2 – Examples of input-output response curves at 1 000 Hz and the
determination of gain at an input level of 55 dB . 12
Figure 3 – Positioning of hearing aid during RF exposure . 12
Figure 4 – Examples of determination of IRIL by electromagnetic immunity (EMI)
testing . 13
Figure A.1 – Ratio of 1:2 between field strength and interference level in dB . 16
Figure A.2 – Example of test arrangement for hearing aid immunity measurements
using dipole antenna . 18
Figure A.3 – Digital wireless devices antenna designs . 19

Table 1 – Field strengths of RF test signals to be used to establish immunity for
bystander compatible and user compatible hearing aids . 9

60118-13  IEC:2011 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
ELECTROACOUSTICS –
HEARING AIDS –
Part 13: Electromagnetic compatibility (EMC)

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
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3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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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 60118-13 has been prepared by IEC technical committee 29:
Electroacoustics. It has the status of a product EMC standard in accordance with
IEC Guide 107, Electromagnetic compatibility – Guide to the drafting of electromagnetic
compatibility publications.
This third edition cancels and replaces the second edition published in 2004 and constitutes a
technical revision. It introduces a new set of requirements for use of hearing aids with mobile
phones.
– 4 – 60118-13  IEC:2011
The text of this standard is based on the following documents:
...