EN IEC 60645-7:2025

SLOVENSKI STANDARD
01-december-2025
Nadomešča:
SIST EN 60645-7:2010
SIST EN IEC 60645-3:2021
Elektroakustika - Avdiometrična oprema - 7. del: Instrumenti za merjenje slušnih
potencialov (IEC 60645-7:2025)
Electroacoustics - Audiometric equipment - Part 7: Instruments for the measurement of
auditory evoked potentials (IEC 60645-7:2025)
Akustik - Audiometer - Teil 7: Geräte zur Messung von akustisch evozierten Potentialen
(IEC 60645-7:2025)
Électroacoustique - Appareils audiométriques - Partie 7: Instruments pour le mesurage
des potentiels évoqués auditifs (IEC 60645-7:2025)
Ta slovenski standard je istoveten z: EN IEC 60645-7:2025
ICS:
17.140.50 Elektroakustika Electroacoustics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 60645-7

NORME EUROPÉENNE
EUROPÄISCHE NORM October 2025
ICS 17.140.50 Supersedes EN 60645-7:2010; EN IEC 60645-3:2020
English Version
Electroacoustics - Audiometric equipment - Part 7: Instruments
for the measurement of auditory evoked potentials
(IEC 60645-7:2025)
Électroacoustique - Appareils audiométriques - Partie 7: Akustik - Audiometer - Teil 7: Geräte zur Messung von
Instruments pour le mesurage des potentiels évoqués akustisch evozierten Potentialen
auditifs (IEC 60645-7:2025)
(IEC 60645-7:2025)
This European Standard was approved by CENELEC on 2025-09-26. 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
© 2025 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60645-7:2025 E

European foreword
The text of document 29/1189/CDV, future edition 2 of IEC 60645-7, prepared by 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) 2026-10-31
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2028-10-31
document have to be withdrawn
This document supersedes EN 60645-7:2010 and EN IEC 60645-3:2020 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.
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 60645-7:2025 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 61672-1 NOTE Approved as EN 61672-1
ISO 8253-2 NOTE Approved as EN ISO 8253-2
IEC 60645-6 NOTE Approved as EN IEC 60645-6
IEC 60601-2-40 NOTE Approved as EN IEC 60601-2-40
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 60318-1 - Electroacoustics - Simulators of human head EN 60318-1 -
and ear - Part 1: Ear simulator for the
measurement of supra-aural and
circumaural earphones
IEC 60318-3 - Electroacoustics - Simulators of human head EN 60318-3 -
and ear - Part 3: Acoustic coupler for the
calibration of supra-aural earphones used in
audiometry
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 cm coupler for the
measurement of hearing aids and
earphones coupled to the ear by means of
ear inserts
IEC 60318-6 - Electroacoustics - Simulators of human head EN 60318-6 -
and ear - Part 6: Mechanical coupler for the
measurement on bone vibrators
IEC 60601-1 - Medical electrical equipment – Part 1: - -
General requirements for basic safety and
essential performance
IEC 60645-1 2017 Electroacoustics - Audiometric equipment - EN 60645-1 2017
Part 1: Equipment for pure-tone and speech
audiometry
IEC 61260-1 - Electroacoustics - Octave-band and EN 61260-1 -
fractional-octave-band filters - Part 1:
Specifications
ISO 389-6 - Acoustics - Reference zero for the EN ISO 389-6 -
calibration of audiometric equipment – Part
6: Reference threshold of hearing for test
signals of short duration
ISO/IEC Guide 98- - Uncertainty of measurement - Part 3: Guide - -
3 to the expression of uncertainty in
measurement (GUM:1995)
IEC 60645-7 ®
Edition 2.0 2025-08
INTERNATIONAL
STANDARD
Electroacoustics - Audiometric equipment -
Part 7: Instruments for the measurement of auditory evoked potentials
ICS 17.140.50  ISBN 978-2-8327-0589-6

IEC 60645-7:2025-08(en)
IEC 60645-7:2025 © IEC 2025
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 Requirements for specific instruments . 11
5 General specifications . 12
5.1 Measuring system . 12
5.1.1 Units of measurement . 12
5.1.2 Measurement range . 12
5.1.3 Time resolution . 12
5.2 Stimulus system . 12
5.2.1 General requirements . 12
5.2.2 Stimulus types. 12
5.3 Test quality assuring system . 13
5.3.1 Recording conditions . 13
5.3.2 Response detection. 13
5.3.3 Quality estimates . 13
5.4 Presentation of results . 13
6 Reference signals . 13
6.1 General . 13
6.2 Reference click . 14
6.3 Reference tone-burst . 15
6.4 Reference broadband chirp . 15
6.5 Reference octave-band chirps . 16
7 Calibration and measurement of short-duration signals . 16
8 Demonstration of conformity with specifications . 16
8.1 General . 16
8.2 Signal-to-noise ratio improvement . 17
8.3 Maximum permitted expanded uncertainty of measurements U . 17
max
9 General requirements. 17
9.1 Marking . 17
9.2 Instruction manual . 17
9.3 Safety requirements . 17
9.3.1 General . 17
9.3.2 Immunity to power and radiofrequency fields . 17
9.4 Warm-up time . 18
9.5 Voltage supply variation and environmental conditions . 18
9.5.1 Mains operation . 18
9.5.2 Battery operation . 18
9.5.3 Environmental conditions . 18
10 Periodic calibration . 18
Annex A (informative) Relationship between tolerance interval, corresponding
acceptance interval and the maximum permitted uncertainty of measurement . 19
Bibliography . 20
IEC 60645-7:2025 © IEC 2025
Figure 1 – Basic specification of an electrical reference click . 8
Figure 2 – Illustration of the method of measurement of peak-to-peak equivalent signal
levels . 8
Figure 3 – Temporal characteristics of an electrical reference tone-burst . 9
Figure 4 – Time domain specification of the electrical reference click . 14
Figure 5 – Temporal characteristics of the electrical reference broadband chirp . 15
Figure A.1 – Relationship between tolerance interval, corresponding acceptance interval
and the maximum permitted uncertainty of measurement . 19

Table 1 – Instrumentation requirements. 11
Table 2 – Documentation of test conditions, parameters and results . 13
Table 3 – Values of U for basic measurements . 17
max
IEC 60645-7:2025 © IEC 2025
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
Electroacoustics - Audiometric equipment-
Part 7: Instruments for the measurement of auditory evoked potentials

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) IEC draws attention to the possibility that the implementation of this document may involve the use of (a) patent(s).
IEC takes no position concerning the evidence, validity or applicability of any claimed patent rights in respect thereof.
As of the date of publication of this document, IEC had not received notice of (a) patent(s), which may be required
to implement this document. However, implementers are cautioned that this may not represent the latest information,
which may be obtained from the patent database available at https://patents.iec.ch. IEC shall not be held responsible
for identifying any or all such patent rights.
IEC 60645-7 has been prepared by IEC technical committee 29: Electroacoustics. It is an
International Standard.
This second edition cancels and replaces the first edition published in 2009 and IEC 60645-3:2020.
This edition constitutes a technical revision.
IEC 60645-7:2025 © IEC 2025
This edition includes the following significant technical changes with respect to the previous
edition: the contents of IEC 60645-3:2020 have been incorporated into this document to bring it in
line with other parts of the IEC 60645 series, where the specification of the instrument and the
associated test stimuli are included together in the same standard.
The text of this International Standard is based on the following documents:
Draft Report on voting
29/1189/CDV 29/1199/RVC
Full information on the voting for its approval can be found in the report on voting indicated in the
above table.
The language used for the development of this International Standard is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available at
www.iec.ch/members_experts/refdocs. The main document types developed by IEC are described
in greater detail at www.iec.ch/publications.
A list of all parts in the IEC 60645 series, published under the general title Electroacoustics –
Audiometric equipment, 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 webstore.iec.ch in the data related to the specific
document. At this date, the document will be
– reconfirmed,
– withdrawn, or
– revised.
IEC 60645-7:2025 © IEC 2025
INTRODUCTION
Developments in the field of diagnostic hearing measurement have resulted in a number of
instruments designed to evaluate the auditory evoked potentials of the human hearing system
which can be evoked by acoustic or vibratory signals having different spectral and temporal
characteristics.
The practical use of such instruments concerns the measurement of these electric potentials and
their separation from electric signals emerging from other physiological or artificial sources.
Conformance to the performance specification in this document is demonstrated when a measured
deviation from a design goal equals or does not exceed the corresponding acceptance limit(s),
and the laboratory has demonstrated that the associated uncertainty of measurement equals or
does not exceed the maximum permitted uncertainty specified in this document.

IEC 60645-7:2025 © IEC 2025
1 Scope
This part of IEC 60645 applies to instruments designed for the measurement of auditory evoked
potentials from the inner ear, the auditory nerve, and the brainstem, evoked by either acoustic or
vibratory stimuli of short duration. This document defines the characteristics to be specified by the
manufacturer, specifies performance requirements for two types of instruments (screening and
diagnostic/clinical), and specifies the functions to be provided on these types. It also specifies a
means of describing the physical characteristics, in terms of electrical waveforms, of audiometric
reference and test signals of short duration used with auditory evoked potential equipment and
other equipment (e.g. otoacoustic emission instruments), and methods for their measurement.
The purpose of this document is to ensure that measurements made under comparable test
conditions with different instruments complying with this document will be consistent. This
document is not intended to restrict development or incorporation of new features, nor to
discourage innovative approaches.
Evoked response measurement using the application of electric stimuli to a subject is beyond the
scope of this document.
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 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance
IEC 60318-1, Electroacoustics - Simulators of human head and ear - Part 1: Ear simulator for the
measurement of supra-aural and circumaural earphones
IEC 60318-3, Electroacoustics - Simulators of human head and ear - Part 3: Acoustic coupler for
the calibration of supra-aural earphones used in audiometry
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 60318-6, Electroacoustics - Simulators of human head and ear - Part 6: Mechanical coupler
for the measurement on bone vibrators
IEC 60645-1:2017, Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone
and speech audiometry
IEC 61260-1, Electroacoustics - Octave-band and fractional-octave-band filters - Part 1:
Specifications
ISO/IEC Guide 98-3, Uncertainty of measurement – Part 3: Guide to the expression of uncertainty
in measurement (GUM:1995)
ISO 389-6, Acoustics – Reference zero for the calibration of audiometric equipment – Part 6:
Reference threshold of hearing for test signals of short duration
IEC 60645-7:2025 © IEC 2025
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
– IEC Electropedia: available at https://www.electropedia.org/
– ISO Online browsing platform: available at https://www.iso.org/obp
3.1
auditory evoked potentials
AEP
electric potentials which can be evoked by acoustic or vibratory stimulation of the auditory system
and recorded by means of electrodes
3.2
auditory brainstem response
ABR
transient AEPs generated in the inner ear, the auditory nerve, and the brainstem after stimulation
of the ear with an acoustic or vibratory force stimulus of short duration
Note 1 to entry: A method for recording the ABRs is also known as BERA (brainstem electric response audiometry).
3.3
automated auditory brainstem response
AABR
automatic detection of auditory brainstem responses
3.4
nHL
hearing level of otologically normal adults as determined through the use of short-duration signals
calibrated using the peak-to-peak method
Note 1 to entry: nHL can also be termed "nor
...