SIST EN IEC 60645-7:2025
(Main)Electroacoustics - Audiometric equipment - Part 7: Instruments for the measurement of auditory evoked potentials (IEC 60645-7:2025)
Electroacoustics - Audiometric equipment - Part 7: Instruments for the measurement of auditory evoked potentials (IEC 60645-7:2025)
IEC 60645-7:2025 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.
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)
L'IEC 60645-7:2025 s'applique aux instruments conçus pour le mesurage des potentiels évoqués auditifs de l'oreille interne, du nerf auditif et du tronc cérébral, évoqués par des stimuli acoustiques ou vibratoires de courte durée. Le présent document définit les caractéristiques qui doivent être spécifiées par le fabricant, spécifie les exigences de performances pour deux types d'instruments (dépistage et diagnostic/utilisation clinique) et spécifie les fonctions à prévoir sur ces types. Il spécifie également un moyen pour décrire les caractéristiques physiques, en matière de formes d'onde électriques, des signaux de référence et d'essai audiométriques de courte durée utilisés avec les équipements de mesure de potentiels évoqués auditifs et avec d'autres équipements (par exemple, instruments de mesure d'émissions otoacoustiques), ainsi que les méthodes de mesure associées. Le présent document a pour objet de s'assurer que les mesurages réalisés dans des conditions d'essai comparables avec différents instruments conformes au présent document sont cohérents. Le présent document n'est pas destiné à limiter le développement ou l'ajout de nouvelles caractéristiques ni à décourager les approches innovantes. Le mesurage des potentiels évoqués par l'application de stimuli électriques sur un sujet ne relève pas du domaine d'application du présent document.
Elektroakustika - Avdiometrična oprema - 7. del: Instrumenti za merjenje slušnih potencialov (IEC 60645-7:2025)
General Information
Relations
Standards Content (Sample)
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 standa
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