IEC 60645-6:2022
(Main)Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions
Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions
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.
Électroacoustique - Équipements audiométriques - Partie 6: Instruments pour la mesure des émissions otoacoustiques
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.
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IEC 60645-6 ®
Edition 2.0 2022-03
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Electroacoustics – Audiometric equipment –
Part 6: Instruments for the measurement of otoacoustic emissions
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
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International Standards for all electrical, electronic and related technologies.
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IEC 60645-6 ®
Edition 2.0 2022-03
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Electroacoustics – Audiometric equipment –
Part 6: Instruments for the measurement of otoacoustic emissions
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 17.140.50 ISBN 978-2-8322-4334-3
– 2 – IEC 60645-6:2022 RLV © 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 . 10
5.1 Acoustic stimulus system . 10
5.1.1 General requirements . 10
5.1.2 Stimulus types . 10
5.1.3 Stimulus frequency range . 11
5.1.4 Stimulus level . 11
5.1.5 Harmonic Intermodulation distortion. 12
5.2 Test quality assuring system . 12
5.2.1 General Stability of acoustic response in the external auditory meatus . 12
5.2.2 Test quality assurance . 13
5.2.3 Individual stimulus recordings . 13
5.3 Measuring system . 13
5.3.1 Units of measurement . 13
5.3.2 Measurement range . 13
5.3.3 Accuracy of measurement . 13
5.3.4 Frequency range . 13
5.3.5 Noise reduction . 13
5.3.6 Response detection . 14
5.3.7 Response quality estimates . 14
5.3.8 Normative values . 14
5.4 Presentation of results . 14
5.4.1 General .
5.4.2 Primary results .
5.4.3 Secondary results .
6 Demonstration of conformity with specifications . 15
6.1 General . 15
6.2 Probe signal . 15
6.2.1 Probe signal frequency spectrum . 15
6.2.2 Probe signal level and harmonic distortion . 15
6.2.3 Probe measurement accuracy . 16
6.3 Complete system . 16
6.4 Function of the complete system .
6.4 Maximum permitted expanded uncertainty of measurements U . 16
max
7 General requirements . 17
7.1 Marking . 17
7.2 Instruction manual . 17
7.3 Safety requirements . 17
7.4 Immunity to power and radiofrequency fields. 17
7.5 Warm-up time . 18
7.6 Voltage supply variation and environmental conditions. 18
7.6.1 Mains operation . 18
7.6.2 Battery operation . 18
7.6.3 Environmental conditions . 18
8 Additional characteristics to be specified by the manufacturer . 18
9 Routine Periodic calibration . 18
Bibliography . 20
Table 1 – Mandatory functions for otoacoustic emission instruments. 9
Table 2 – Documentation of test conditions, parameters and results . 14
Table 3 – Values of U for basic conformance and periodic calibration
max
measurements . 17
– 4 – IEC 60645-6:2022 RLV © 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
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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.
This redline version of the official IEC Standard allows the user to identify the changes made to
the previous edition IEC 60645-6:2009. A vertical bar appears in the margin wherever a change
has been made. Additions are in green text, deletions are in strikethrough red text.
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;
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
th
...
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
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.
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les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.
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CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.
IEC publications search - webstore.iec.ch/advsearchform IEC Products & Services Portal - products.iec.ch
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variety of criteria (reference number, text, technical publications previews. With a subscription you will always
committee, …). It also gives information on projects, replaced have access to up to date content tailored to your needs.
and withdrawn publications.
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IEC Just Published - webstore.iec.ch/justpublished
The world's leading online dictionary on electrotechnology,
Stay up to date on all new IEC publications. Just Published
containing more than 22 300 terminological entries in English
details all new publications released. Available online and
and French, with equivalent terms in 19 additional languages.
once a month by email.
Also known as the International Electrotechnical Vocabulary
(IEV) online.
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If you wish to give us your feedback on this publication or
need further assistance, please contact the Customer Service
Centre: sales@iec.ch.
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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
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
...
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