EN IEC 60118-0:2024

SLOVENSKI STANDARD
01-julij-2024
Elektroakustika - Slušni aparati - 0. del: Meritve tehničnih karakteristik slušnih
aparatov (IEC 60118-0:2022)
Electroacoustics - Hearing aids - Part 0: Measurement of the performance characteristics
of hearing aids (IEC 60118-0:2022)
Akustik - Hörgeräte - Teil 0: Messung der Leistungsmerkmale von Hörgeräten (IEC
60118-0:2022)
Electroacoustique - Appareils de correction auditive - Partie 0: Mesure des
caractéristiques fonctionnelles des appareils de correction auditive (IEC 60118-0:2022)
Ta slovenski standard je istoveten z: EN IEC 60118-0:2024
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 60118-0

NORME EUROPÉENNE
EUROPÄISCHE NORM May 2024
ICS 17.140.50 Supersedes EN 60118-0:2015
English Version
Electroacoustics - Hearing aids - Part 0: Measurement of the
performance characteristics of hearing aids
(IEC 60118-0:2022)
Électroacoustique - Appareils de correction auditive - Partie Akustik - Hörgeräte - Teil 0: Messung der
0: Mesure des caractéristiques fonctionnelles des appareils Leistungsmerkmale von Hörgeräten
de correction auditive (IEC 60118-0:2022)
(IEC 60118-0:2022)
This European Standard was approved by CENELEC on 2022-10-04. 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,
Türkiye 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
© 2024 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60118-0:2024 E

European foreword
The text of document 29/1126/FDIS, future edition 4 of IEC 60118-0, 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) 2024-11-10
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2027-05-10
document have to be withdrawn
This document supersedes EN 60118-0:2015 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 standardization request addressed to CENELEC by the
European Commission. The Standing Committee of the EFTA States subsequently approves these
requests for its Member States.
For the relationship with EU Legislation, see informative Annex ZZ, which is an integral part of this
document.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60118-0:2022 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 standard indicated:
IEC 60068 (series) NOTE Approved as EN 60068 (series)
IEC 60118-7:2005 NOTE Approved as EN 60118-7:2005 (not modified)
IEC 60118-8:2005 NOTE Approved as EN 60118-8:2005 (not modified)
IEC 60118-15 NOTE Approved as EN 60118-15
IEC 61094-8:2012 NOTE Approved as EN 61094-8:2012 (not modified)
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.cencenelec.eu.
Publication Year Title EN/HD Year
IEC 60118-12 - Hearing aids – Part 12: Dimensions of EN 60118-12 1996
electrical connector systems
IEC 60318-4 2010 Electroacoustics – Simulators of human head EN 60318-4 2010
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 2006
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 60318-8 - Electroacoustics – Simulators of human head EN 60318-8 2022
and ear – Part 8: Acoustic coupler for high-
frequency measurements of hearing aids and
earphones coupled to the ear by means of
ear inserts
IEC 60268-2 1987 Sound system equipment – Part 2: - -
Explanation of general terms and calculation
methods
+ AMD 1 1991 - -
IEC 60263 - Scales and sizes for plotting frequency EN IEC 60263 2020
characteristics and polar diagrams
IEC 61094-4 - Measurement microphones – Part 4: EN 61094-4 1995
Specifications for working standard
microphones
ISO 3 1973 Preferred numbers – Series of preferred
numbers
Annex ZZ
(informative)
Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745
aimed to be covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/745 of 5
April 2017 concerning medical devices [OJ L 117] and to system or process requirements including
those relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative 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 General Safety and
Performance Requirements of that Regulation, and associated EFTA Regulations.
Where a definition in this standard differs from a definition of the same term set out in Regulation (EU)
2017/745, the differences shall be indicated in this Annex Z. For the purpose of using this standard in
support of the requirements set out in Regulation (EU) 2017/745, the definitions set out in this
Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this standard
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region, the standard can only
support European regulatory requirements to the extent of the scope of the European Regulation for
medical devices (EU) 2017/745).
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 Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far
as possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General
Safety and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the
Regulation.
NOTE 3 When a General Safety and Performance 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 Regulation (EU)
2017/745 [OJ L 117] and to system or process requirements including those relating to quality
management systems, risk management, post-market surveillance systems, clinical
investigations, clinical evaluation or post-market clinical follow-up
General Safety and
Clause(s) / sub-
Performance
clause(s)
Remarks / Notes
Requirements of
of this EN
Regulation (EU) 2017/745
1 Clauses 7, 8, 9, 10 Coverage is limited to electro-acoustic
performance measurements and measurement

of the safety relevant maximum acoustic output
of hearing aids.
It should be noted, the measurement results
obtained by the methods specified in this
document will express the performance under
conditions of the measurement and can deviate
substantially from the performance of the
hearing aid under actual conditions of use.
10.1. (h) Clause 10 Covers measurement procedures for the
electro-acoustical parameters of hearing aids

14.2. (a) Clause 10.4 Covers the measurement and specification of
the safety relevant maximum output sound

pressure level of a hearing aid;
The risk of hearing damage, if measurement
exceeds specified measurement uncertainty
limits and/or tolerances, is mitigated by process
control, such as training, regular maintenance
and calibration of equipment.
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 product(s) falling within the scope of
this standard.
IEC 60118-0 ®
Edition 4.0 2022-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Electroacoustics – Hearing aids –

Part 0: Measurement of the performance characteristics of hearing aids

Électroacoustique – Appareils de correction auditive –

Partie 0: Mesure des caractéristiques fonctionnelles des appareils de correction

auditive
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 17.140.50 ISBN 978-2-8322-5591-9

– 2 – IEC 60118-0:2022 © IEC 2022
CONTENTS
FOREWORD . 7
1 Scope . 9
2 Normative references . 9
3 Terms and definitions . 10
4 General conditions. 15
4.1 Acoustic measurement method . 15
4.2 Acoustic couplers and occluded ear simulator . 15
4.3 Input signals and frequency range . 17
4.4 Reporting of data . 17
5 Test equipment . 17
5.1 General . 17
5.2 Test enclosure . 18
5.2.1 General . 18
5.2.2 Type 1 "anechoic-chamber" . 18
5.2.3 Type 2 "test-box" .
...