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

This part of IEC 60118 in principle covers all relevant EMC phenomena for hearing aids. EMC phenomena, such as RF emission and electrostatic discharge, are not currently known to be a significant problem in connection with hearing aids and are therefore not dealt with. Based on new knowledge, they could be considered in connection with future revisions or extensions of this standard. 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. For the purpose of this part of IEC 60118, two immunity classes of hearing aids are defined (see 3.1) related to their use. "Bystander compatible" ensures that a hearing aid is usable in environments where digital wireless devices are in operation in the proximity of the hearing aid wearer. "User compatible" hearing aids ensures that a hearing aid is usable when the wearer is using a digital wireless device at the wearer’s own aided ear. Measurement methods for hearing aids with non-acoustic outputs and for hearing aids connected to other equipment by cables are not given in this standard.

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
Published
Publication Date
14-Sep-2011
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
07-Sep-2011
Due Date
12-Nov-2011
Completion Date
15-Sep-2011

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SLOVENSKI STANDARD
SIST EN 60118-13:2011
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
SIST EN 60118-13:2011 en

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

---------------------- Page: 1 ----------------------
SIST EN 60118-13:2011
---------------------- Page: 2 ----------------------
SIST EN 60118-13:2011
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
---------------------- Page: 3 ----------------------
SIST EN 60118-13:2011
EN 60118-13:2011 - 2 -
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.

EN 60118-13:2011 introduces a new set of requirements for use of hearing aids with mobile phones.

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.
__________
---------------------- Page: 4 ----------------------
SIST EN 60118-13:2011
- 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
---------------------- Page: 5 ----------------------
SIST EN 60118-13:2011
EN 60118-13:2011 - 4 -
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.
---------------------- Page: 6 ----------------------
SIST EN 60118-13:2011
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
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 7 ----------------------
SIST EN 60118-13:2011
– 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

---------------------- Page: 8 ----------------------
SIST EN 60118-13:2011
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

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. 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.
---------------------- Page: 9 ----------------------
SIST EN 60118-13:2011
– 4 – 60118-13  IEC:2011
The text of this standard is based on the following documents:
FDIS Report on voting
29/737/FDIS 29/745/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 publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

A list of all parts of the IEC 60118 series, under the general title: Electroacoustics – Hearing

aids, can be found on the IEC website.

The committee has decided that the contents of this publication will remain unchanged until

the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data

related to the specific publication. At this date, the publication 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.
---------------------- Page: 10 ----------------------
SIST EN 60118-13:2011
60118-13  IEC:2011 – 5 –
INTRODUCTION
This standard introduces specifications for EMC requirements for hearing aids.

Hearing aids basically consist of a microphone, an amplifier, a 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). In the ear (ITE) hearing

aids have the active circuitry located in the auditory canal.

The power source normally used is a small battery. On some hearing aids, the user can

perform some adjustments of the controls of the hearing aid, which in some cases is by

means of a remote control.

The standard only deals with hearing aid immunity, as experience has shown that hearing

aids do not emit electromagnetic signals to an extent that can disturb other equipment. Other

EMC phenomena, such as RF emission and electrostatic discharge, are not currently known

to be a significant problem in connection with hearing aids. Based on new knowledge, they

could be considered in connection with future revisions or extensions of this standard.

Hearing aids containing RF transmitting equipment are covered by this standard regarding

immunity, however the RF transmitting equipment is not covered. Experience in connection

with the use of hearing aids in recent times has identified digital wireless devices, such as

DECT wireless phones and GSM mobile phones as potential sources of disturbance for

hearing aids. Interference in hearing aids depends on the emitted power from the wireless

telephone as well as the immunity of the hearing aid. The performance criteria in this standard

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 digital wireless device, will seek, if possible, to find a position on the ear

which gives a minimum or no interference in the hearing aid.

Hearing aids are battery powered devices, and therefore disturbances related to a.c. or d.c.

power inputs are not relevant and are therefore not considered in this standard.

Hearing aids whose outputs are non-acoustic, e.g. cochlear implants and bone conduction

hearing aids, are not covered by this standard.

In some cases, hearing aids are connected to other equipment by cable, but this standard

does not cover common mode transients and common mode surges on such cable
connections.

Based on experience in connection with the use of hearing aids, relevant sources of

disturbance for hearing aids include low frequency radiated magnetic fields, which may

interact with the induction pick-up coil input included in some hearing aids. As the induction

pick-up coil input is an intended feature of some hearing aids, and the hearing aid therefore

must have a certain sensitivity to low frequency magnetic fields, it is not relevant to specify

immunity against disturbing low frequency magnetic fields. To avoid unintended interference

from low frequency magnetic noise fields, the recommendations specified in IEC 60118-4 [1] ,

regarding specifications for induction loop systems, should be followed.

With regard to high frequency radiated electromagnetic fields originating from RF wireless

devices such as digital mobile telephone systems, only sources of disturbance which are

currently known to be a problem in connection with hearing aids are covered. Reference is

made to IEC 61000-4-3, which identifies digital radio telephone systems operating in the

frequency ranges 0,8 GHz to 0,96 GHz and 1,4 GHz to 2,48 GHz to be potential sources of

interference. Future versions may add tests for other frequency bands, as they come into

more common use. Hearing aids are used in all environments as outlined in IEC 61000-4-3.

___________
Figures in square brackets refer to the bibliography.
---------------------- Page: 11 ----------------------
SIST EN 60118-13:2011
– 6 – 60118-13  IEC:2011

Various test methods have been considered for determining the immunity of hearing aids.

When a wireless telephone is used close to a hearing aid, there is an RF near-field

illumination of the hearing aid. However, validation investigations in preparing this standard

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 bring valuable information during design and development of hearing

aids.
---------------------- Page: 12 ----------------------
SIST EN 60118-13:2011
60118-13  IEC:2011 – 7 –
ELECTROACOUSTICS –
HEARING AIDS –
Part 13: Electromagnetic compatibility (EMC)
1 Scope

This part of IEC 60118 in principle covers all relevant EMC phenomena for hearing aids. EMC

phenomena, such as RF emission and electrostatic discharge, are not currently known to be a

significant problem in connection with hearing aids and are therefore not dealt with. Based on

new knowledge, they could be considered in connection with future revisions or extensions of

this standard. 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.

For the purpose of this part of IEC 60118, two immunity classes of hearing aids are defined

(see 3.1) related to their use. "Bystander compatible" ensures that a hearing aid is usable in

environments where digital wireless devices are in operation in the proximity of the hearing

aid wearer. "User compatible" hearing aids ensures that a hearing aid is usable when the

wearer is using a digital wireless device at the wearer’s own aided ear.

Measurement methods for hearing aids with non-acoustic outputs and for hearing aids

connected to other equipment by cables are not given in this standard.
2 Normative references

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.

IEC 60118-0, Hearing aids – Part 0: Measurement of electroacoustical characteristics

IEC 60118-2, Hearing aids – Part 2: Hearing aids with automatic gain control circuits

IEC 60118-7, Electroacoustics – Hearing aids – 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 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 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

---------------------- Page: 13 ----------------------
SIST EN 60118-13:2011
– 8 – 60118-13  IEC:2011
3 Terms and definitions

For the purposes of this document, the terms and definitions given in IEC 60118-0,

IEC 60118-7, and IEC 61000-4-3 as well as the following apply.
3.1
hearing aid

wearable instrument, containing a variety of individual adjustment facilities, intended to aid a

person with impaired hearing. Consisting of a microphone, amplifier, an induction pick-up coil

(optional) and earphone, powered by a battery

NOTE Hearing aids can be placed on the body (BW), behind the ear (BTE) or in the ear (ITE).

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 (2 m, see A.4)

3.3
user compatibility

immunity of a hearing aid that ensures it is usable when the wearer is using a digital wireless

device at the wearer´s own aided ear
3.4
reference orientation (of a hearing aid)

orientation of the hearing aid with respect to the RF emitting source which corresponds to the

orientation of the hearing aid under actual use on a person facing or using an RF emitting

source
3.5
input related interference level
IRIL
level used to characterise the immunity of the hearing aid

NOTE Acoustic IRIL is expressed relative to 20 µPa in decibels, and is calculated by subtracting the gain of the

hearing aid from the level of a 1 kHz signal measured at the output of the hearing aid during exposure to a 1 kHz

modulated RF field in microphone mode. The gain of the hearing aid is determined at 1 kHz using an input sound

pressure level of 55 dB.

If the hearing aid provides an additional directional microphone, the gain determined with the omnidirectional

microphone is used for determination of IRIL.

If the hearing aid provides an induction pick-up coil, the control settings used for acoustic measurement are used.

Induction pick-up coil IRIL is expressed as the equivalent acoustic input r.m.s levels re 20 µPa in decibels, based

on the assumption that the magnetic field strength level re 1A/m of –20 dB is practically equivalent to the acoustic

sound pressure level of 70 dB.

The induction pick-up coil IRIL is calculated by subtracting the output of the hearing aid in dB minus 55 dB, from

the level of 1 kHz signal measured at the output of the hearing aid during exposure to a 1 kHz 80% modulated RF

field in induction pick-up coil mode.
Decreasing values of IRIL indicate increasing immunity.
Further details are given in Annex A.
3.6
GSM
global system for mobile communication
___________
Determined at –35 dB input level re 1A/m at 1 kHz.
---------------------- Page: 14 ----------------------
SIST EN 60118-13:2011
60118-13  IEC:2011 – 9 –
3.7
TEM cell

closed measuring device in which a voltage difference creates a TEM-mode electromagnetic

field
3.8
radio frequency
frequency of electromagnetic radiation within the range of 30 kHz to 30 GHz
4 Requirements for immunity

Table 1 states the field strengths of RF test signals to establish immunity for bystander

compatible and user compatible hearing aids. Bystander compatibility shall be fulfilled as a

minimum specification, whereas user compatibility is an additional feature, which can be

claimed if the specifications are met by the hearing aid.

Table 1 – Field strengths of RF test signals to be used to establish immunity for

bystander compatible and user compatible hearing aids
Bystander compatibility User compatibility
IRIL ≤ 55 dB for field strengths, IRIL ≤ 55 dB for field strengths,
E in V/m E in V/m

Frequency <0,8 0,8- 0,96-1,4 1,4- 2,0- >2,48 <0,8 0,8-0,96 0,96-1,4 1,4-2,0 2,0-2,48 >2,48

range GHz 0,96 2,0 2,48
Microphone Unneces 3,5 Unneces 2 1,5 Unneces Unneces 90 Unneces 50 35 Unnece
mode sary sary sary sary sary ssary
Induction Unneces 3,5 Unneces 2 1,5 Unneces Unneces 90 Unneces 50 35 Unnece
pick-up coil sary sary sary sary sary ssary
mode

Directional Unneces 3,5 Unneces 2 1,5 Unneces Unneces Unneces Unneces Unneces Unneces Unnece

microphone sary sary sary sary sary sary sary sary ssary
mode
Test field strengths are given as unmodulated carrier levels.
If provided by the hearing aid.

NOTE 1 Table 1 has been updated for frequencies above 2,0 GHz. Wireless services like Bluetooth operate in the

2,0 GHz to 2,48 GHz range. Services in this frequency range are typically running at lower power levels compared

to services below 1 GHz. TDMA modulation (eg. used in GSM mobile phones and DECT wireless phones) has been

shown to generate the most aggressive interference in hearing aids to date, while CDMA and other modulations

schemes are less aggressive. The test levels used since the first edition of IEC 60118-13 in 1996 have through

testing of more than 1 000 hearing aid models demonstrated to be sufficiently high to ensure well-functioning

hearing aids in daily life, with only a few complaints from hearing aid users who are annoyed by interference from

digital wireless devices. A test field strength 3 dB below the 1,4 GHz to 2,0 GHz range is considered sufficient to

sustain well-functioning hearing aids in daily life regarding interference in the 2,0 GHz to 2,48 GHz range because

services in the latter frequency range are typically running at lower power levels compared to services below

1 GHz. Additional national standards may supplement ranges in Table 1.

NOTE 2 As sources of disturbance in the frequency range 0,96 GHz to 1,4 GHz, below 0,8 GHz and beyond

2,48 GHz are not known to affect hearing aids, testing in this frequency range is not considered necessary. If the

hearing aid provides an additional microphone input option – directional microphone intended for distant listening

in noisy environments – user compatibility
...

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