SIST EN IEC 60645-6:2022
(Main)Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions (IEC 60645-6:2022)
Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions (IEC 60645-6:2022)
IEC 60645-6:2022 is available as IEC 60645-6:2022 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 606045-6:2022 applies to instruments designed primarily for the measurement of otoacoustic emissions in the human external auditory meatus evoked by acoustic probe stimuli. This document defines the characteristics to be specified by the manufacturer, specifies minimum mandatory functions for two types of instruments and provides performance specifications applicable to both instrument types. This document describes methods to be used to demonstrate conformance with the specifications in this document and guidance on methods for periodic calibration. 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. Instruments can provide a measurement function not specifically within the scope of this document and still comply with the relevant requirements of this document for the functions that are within the scope. This document is not intended to restrict development or incorporation of new features, nor to discourage innovative approaches. IEC 606045-6:2022 cancels and replaces the first edition published in 2009. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) the nominal test frequency used in DPOAE is now defined as the higher of the two frequencies, f2;
b) the permitted deviation of the stimulus signal for TEOAE has been specified;
c) the frequency range for DPOAE stimulus signals has been redefined,
d) the stimulus level requirements for TEOAE have been redefined;
e) the stimulus level requirements for DPOAE have been redefined;
f) the harmonic distortion requirements for DPOAE have been redefined;
g) a minimum measurement range for DPOAE has been added.
Akustik - Audiometer - Teil 6: Geräte zur Messung von otoakustischen Emissionen (IEC 60645-6:2022)
Electroacoustique - Equipements audiométriques - Partie 6: Instruments pour la mesure des émissions otoacoustiques (IEC 60645-6:2022)
IEC 60645-6:2022 est disponible sous forme de IEC 60645-6:2022 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.
L'IEC 60645-6:2022 s’applique aux instruments conçus principalement pour le mesurage des émissions otoacoustiques dans le conduit auditif externe humain qui sont évoquées par des stimuli provenant d’une sonde acoustique. Le présent document définit les caractéristiques à spécifier par le fabricant, spécifie les fonctions obligatoires minimales pour deux types d’instruments et fournit des spécifications de performance applicables à ces deux types d’instruments. Le présent document décrit les méthodes à utiliser pour démontrer la conformité aux spécifications du présent document et des recommandations relatives aux méthodes d’étalonnage périodique.
Le présent document a pour objet d’assurer que des mesurages réalisés dans des conditions d’essai comparables avec différents instruments conformes au présent document sont cohérents. Il est possible que les instruments assurent une fonction de mesure qui ne relève pas spécifiquement du domaine d’application du présent document et soient cependant conformes aux exigences pertinentes du présent document concernant les fonctions qui relèvent du présent domaine d’application. Le présent document n’est pas destiné à limiter l'élaboration ou l’ajout de nouvelles caractéristiques ni à décourager les approches innovantes. L'IEC 60645-6:2022 annule et remplace la première édition parue en 2009. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
a) la fréquence d’essai nominale utilisée dans les émissions otoacoustiques de produit de distorsion (DPOAE – Distortion Product Otoacoustic Emissions) est désormais définie comme la plus élevée des deux fréquences, f2;
b) l’écart permis du signal de stimulus pour les émissions otoacoustiques évoquées transitoires (TEOAE – Transient-Evoked Otoacoustic Emissions) a été spécifié;
c) la plage de fréquences pour les signaux de stimulus des DPOAE a été redéfinie;
d) les exigences relatives au niveau de stimulus pour les TEOAE ont été redéfinies;
e) les exigences relatives au niveau de stimulus pour les DPOAE ont été redéfinies;
f) les exigences relatives à la distorsion harmonique pour les DPOAE ont été redéfinies;
g) une étendue de mesure minimale pour les DPOAE a été ajoutée.
Elektroakustika - Avdiometrična oprema - 6. del: Instrumenti za merjenje ušesnoakustičnih emisij (IEC 60645-6:2022)
Ta del standarda IEC 60645 se uporablja za instrumente, zasnovane predvsem za merjenje ušesnoakustičnih emisij v zunanjem slušnem kanalu človeka, ki jih izzovejo dražljaji akustične sonde.
Ta dokument opredeljuje lastnosti, ki jih mora navesti proizvajalec, določa minimalne obvezne funkcije za dve vrsti instrumentov in zagotavlja specifikacije delovanja, ki veljajo za obe vrsti instrumentov. Ta dokument opisuje metode za dokazovanje skladnosti s specifikacijami v tem dokumentu in navodila za metode občasne kalibracije.
Namen tega dokumenta je zagotoviti, da bodo meritve, opravljene v primerljivih preskusnih pogojih z različnimi instrumenti, ki so v skladu s tem dokumentom, skladne.
Instrumenti lahko zagotavljajo merilno funkcijo, ki je področje uporabe tega dokumenta ne zajema izrecno, in so še vedno v skladu z ustreznimi zahtevami tega dokumenta za funkcije, ki spadajo na področje uporabe. Ta dokument ni namenjen omejevanju razvoja ali vključevanju novih funkcij, niti odvračanju od inovativnih pristopov.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2022
Nadomešča:
SIST EN 60645-6:2010
Elektroakustika - Avdiometrična oprema - 6. del: Instrumenti za merjenje
ušesnoakustičnih emisij (IEC 60645-6:2022)
Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of
otoacoustic emissions (IEC 60645-6:2022)
Akustik - Audiometer - Teil 6: Geräte zur Messung von otoakustischen Emissionen (IEC
60645-6:2022)
Electroacoustique - Equipements audiométriques - Partie 6: Instruments pour la mesure
des émissions otoacoustiques (IEC 60645-6:2022)
Ta slovenski standard je istoveten z: EN IEC 60645-6:2022
ICS:
17.140.50 Elektroakustika Electroacoustics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN IEC 60645-6
NORME EUROPÉENNE
EUROPÄISCHE NORM April 2022
ICS 17.140.50 Supersedes EN 60645-6:2010
English Version
Electroacoustics - Audiometric equipment - Part 6: Instruments
for the measurement of otoacoustic emissions
(IEC 60645-6:2022)
Electroacoustique - Appareils audiométriques - Partie 6: Akustik - Audiometer - Teil 6: Geräte zur Messung von
Instruments pour la mesure des émissions otoacoustiques otoakustischen Emissionen
(IEC 60645-6:2022) (IEC 60645-6:2022)
This European Standard was approved by CENELEC on 2022-04-14. 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,
Turkey 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
© 2022 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60645-6:2022 E
European foreword
The text of document 29/1109/FDIS, future edition 2 of IEC 60645-6, 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) 2023-01-14
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2025-04-14
document have to be withdrawn
This document supersedes EN 60645-6:2010 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 given to CENELEC by the
European Commission and the European Free Trade Association.
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 60645-6:2022 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:
ISO 389-6 NOTE Harmonized as EN ISO 389-6
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.cenelec.eu.
Publication Year Title EN/HD Year
IEC 60318-4 - Electroacoustics - Simulators of human EN 60318-4 -
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 EN 60318-5 -
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 60601-1 - Medical electrical equipment - Part 1: EN 60601-1 -
General requirements for basic safety and
essential performance
IEC 60601-1-2 - Medical electrical equipment - Part 1-2: EN 60601-1-2 -
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
IEC 60645-1 2017 Electroacoustics - Audiometric equipment - EN 60645-1 2017
Part 1: Equipment for pure-tone and
speech audiometry
IEC 60645-3 2020 Electroacoustics - Audiometric equipment - EN IEC 60645-3 2020
Part 3: Test signals of short duration
ISO/IEC Guide 98-3 - Uncertainty of measurement - Part 3: - -
Guide to the expression of uncertainty in
measurement (GUM:1995)
IEC 60645-6 ®
Edition 2.0 2022-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Electroacoustics – Audiometric equipment –
Part 6: Instruments for the measurement of otoacoustic emissions
Électroacoustique – Appareils audiométriques –
Partie 6: Instruments pour la mesure des émissions otoacoustiques
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 17.140.50 ISBN 978-2-8322-1086-6
– 2 – IEC 60645-6:2022 © IEC 2022
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 8
4 Requirements for specific instruments . 9
5 General specifications . 9
5.1 Acoustic stimulus system . 9
5.1.1 General requirements . 9
5.1.2 Stimulus types . 9
5.1.3 Stimulus frequency range . 10
5.1.4 Stimulus level . 10
5.1.5 Intermodulation distortion . 11
5.2 Test quality assuring system . 11
5.2.1 Stability of acoustic response in the external auditory meatus . 11
5.2.2 Test quality assurance . 11
5.2.3 Individual stimulus recordings . 11
5.3 Measuring system . 12
5.3.1 Units of measurement . 12
5.3.2 Measurement range . 12
5.3.3 Accuracy of measurement . 12
5.3.4 Frequency range . 12
5.3.5 Noise reduction . 12
5.3.6 Response detection . 12
5.3.7 Response quality estimates . 12
5.3.8 Normative values . 12
5.4 Presentation of results . 12
6 Demonstration of conformity with specifications . 13
6.1 General . 13
6.2 Probe signal . 13
6.2.1 Probe signal frequency spectrum . 13
6.2.2 Probe signal level and harmonic distortion . 13
6.2.3 Probe measurement accuracy . 13
6.3 Complete system . 14
6.4 Maximum permitted expanded uncertainty of measurements U . 14
max
7 General requirements . 15
7.1 Marking . 15
7.2 Instruction manual . 15
7.3 Safety requirements . 15
7.4 Immunity to power and radiofrequency fields. 15
7.5 Warm-up time . 15
7.6 Voltage supply variation and environmental conditions. 15
7.6.1 Mains operation . 15
7.6.2 Battery operation . 15
7.6.3 Environmental conditions . 15
IEC 60645-6:2022 © IEC 2022 – 3 –
8 Additional characteristics to be specified by the manufacturer . 16
9 Periodic calibration . 16
Bibliography . 17
Table 1 – Mandatory functions for otoacoustic emission instruments. 9
Table 2 – Documentation of test conditions, parameters and results . 13
Table 3 – Values of U for conformance and periodic calibration measurements . 14
max
– 4 – IEC 60645-6:2022 © IEC 2022
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
ELECTROACOUSTICS –
AUDIOMETRIC EQUIPMENT –
Part 6: Instruments for the measurement of otoacoustic emissions
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.
IEC 60645-6 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. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) the nominal test frequency used in DPOAE is now defined as the higher of the two
frequencies, f ;
b) the permitted deviation of the stimulus signal for TEOAE has been specified;
c) the frequency range for DPOAE stimulus signals has been redefined,
d) the stimulus level requirements for TEOAE have been redefined;
e) the stimulus level requirements for DPOAE have been redefined;
IEC 60645-6:2022 © IEC 2022 – 5 –
f) the harmonic distortion requirements for DPOAE have been redefined;
g) a minimum measurement range for DPOAE has been added.
The text of this International Standard is based on the following documents:
Draft Report on voting
29/1109/FDIS 29/1114/RVD
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 http://www.iec.ch/standardsdev/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,
• replaced by a revised edition, or
• amended.
– 6 – IEC 60645-6:2022 © IEC 2022
INTRODUCTION
Developments in the field of diagnostic hearing measurement have resulted in a number of
instruments designed to evaluate the otoacoustic emissions of the human ear. Such emissions
may be evoked by acoustic test signals having different spectral and temporal characteristics.
The practical use of such instruments concerns the measurement of sound energy emitted by
the inner ear and its separation from sounds emerging from physiological or other sources.
The spontaneous otoacoustic emissions (SOAE) and stimulus frequency otoacoustic emissions
(SFOAE), which comprise part of the otoacoustic emissions, are not covered by this document.
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 60645-6:2022 © IEC 2022 – 7 –
ELECTROACOUSTICS –
AUDIOMETRIC EQUIPMENT –
Part 6: Instruments for the measurement of otoacoustic emissions
1 Scope
This part of IEC 60645 applies to instruments designed primarily for the measurement of
otoacoustic emissions in the human external auditory meatus evoked by acoustic probe stimuli.
This document defines the characteristics to be specified by the manufacturer, specifies
minimum mandatory functions for two types of instruments and provides performance
specifications applicable to both instrument types. This document describes methods to be used
to demonstrate conformance with the specifications in this document and guidance on methods
for periodic calibration.
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.
Instruments can provide a measurement function not specifically within the scope of this
document and still comply with the relevant requirements of this document for the functions that
are within the scope. This document is not intended to restrict development or incorporation of
new features, nor to discourage innovative approaches.
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 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 60601-1, Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance
IEC 60601-1-2, Medical electrical equipment – Part 1-2: General requirements for basic safety
and essential performance – Collateral standard: Electromagnetic disturbances – Requirements
and tests
IEC 60645-1:2017, Electroacoustics – Audiometric equipment – Part 1: Equipment for pure-
tone and speech audiometry
IEC 60645-3:2020, Electroacoustics – Aud
...
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