SIST EN 60645-6:2010

Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions (IEC 60645-6:2009)

This part of IEC 60645 applies to instruments designed primarily for the measurement of otoacoustic emissions in the human external acoustic meatus evoked by acoustic probe pulses or tones. This standard defines the characteristics to be specified by the manufacturer, lays down performance specifications for two types of instruments1 and specifies the functions to be provided on these types. This part of IEC 60645 describes methods of test to be used for approval testing and guidance on methods for undertaking routine calibration. The purpose of this part of IEC 60645 is to ensure that measurements made under comparable test conditions with different instruments complying with the standard will be consistent. Instruments which provide a measurement function not specifically within the scope of the standard shall still comply with any relevant requirements. This standard is not intended to restrict development or incorporation of new features, nor to discourage innovative approaches.

Akustik - Audiometer - Teil 6: Geräte zur Messung von otoakustischen Emissionen (IEC 60645-6:2009)

Electroacoustique - Appareillage audiométrique - Partie 6: Instruments pour la mesure des émissions otoacoustiques (CEI 60645-6:2009)

La CEI 60645-6:2009 s'applique aux instruments conçus principalement pour la mesure des émissions otoacoustiques dans le conduit auditif externe humain qui sont évoquées par des impulsions ou des sons provenant d'une sonde acoustique. La présente norme définit les caractéristiques qui doivent être spécifiées par le fabricant, établit des spécifications de performance pour deux types d'instruments et spécifie les fonctionnalités à prévoir sur ces deux types. La CEI 60645-6:2009 décrit les méthodes d'essai à utiliser pour les essais d'homologation et des lignes directrices pour réaliser l'étalonnage de routine. La CEI 60645-6:2009 a pour objet d'assurer que des mesures réalisées dans des conditions d'essai comparables avec différents instruments conformes à cette norme seront cohérentes. Les instruments qui assurent une fonction de mesure qui n'entre pas spécifiquement dans le domaine d'application de la présente norme doivent toujours être conformes aux exigences les concernant quelles qu'elles soient. Cette norme n'est pas destinée à limiter le développement ou l'ajout de nouvelles caractéristiques ni à décourager les approches innovantes.

Elektroakustika - Avdiometrična oprema - 6. del: Instrumenti za merjenje ušesnoakustičnih emisij (IEC 60645-6:2009)

Ta del IEC 60645 velja za instrumente, ki so namenjeni predvsem za merjenje ušesnoakustičnih emisij v človeškem zunanjem sluhovodu, ki jih vzbujajo impulzi ali toni akustičnih sond. Ta standard določa lastnosti, ki jih mora navesti proizvajalec, predpisuje specifikacije zmogljivosti za dve vrsti instrumentov in določa funkcije, ki jih morata ti vrsti izpolnjevati. Ta del IEC 60645 opisuje preskusne metode, ki se morajo uporabljati za homologacijsko preskušanje, in vodilo za metode pri izvajanju rutinske kalibracije. Namen tega dela IEC 60645 je zagotoviti, da so meritve, ki se opravljajo pod primerljivimi preskusnimi pogoji z različnimi instrumenti v skladu s standardom, med seboj skladne. Instrumenti za merjenje, ki ni specifično za okvir uporabe tega standarda, morajo še vedno izpolnjevati vse ustrezne zahteve. Ta standard ni namenjen ne omejevanju razvoja ali vključevanju novih funkcij ne odvračanju od inovativnih pristopov.

General Information

• Status: Published
• Publication Date: 08-Feb-2010
• ICS: 17.140.50 - Electroacoustics
• Technical Committee: I11 - Imaginarni 11
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 12-Jan-2010
• Due Date: 19-Mar-2010
• Completion Date: 09-Feb-2010
• Directive: 2006/95/EC - Directive 2006/95/EC of the European Parliament and of the Council of 12 December 2006 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits (codified version)
• Directive: 2014/35/EU - Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN 60645-6:2010 - Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions

Relations

• Replaced By: SIST EN IEC 60645-6:2022 - Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions (IEC 60645-6:2022)
• Effective Date: 26-Apr-2022
• Replaced By: SIST EN IEC 60645-6:2022 - Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions (IEC 60645-6:2022)
• Effective Date: 07-Jun-2022
• Revised: SIST EN IEC 60645-6:2022 - Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions (IEC 60645-6:2022)
• Effective Date: 03-Aug-2020

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60645-6:2010
01-marec-2010
(OHNWURDNXVWLND$YGLRPHWULþQDRSUHPDGHO,QVWUXPHQWL]DPHUMHQMH
XãHVQRDNXVWLþQLKHPLVLM,(&
Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of
otoacoustic emissions (IEC 60645-6:2009)
Akustik - Audiometer - Teil 6: Geräte zur Messung von otoakustischen Emissionen (IEC
60645-6:2009)
Electroacoustique - Appareillage audiométrique - Partie 6: Instruments pour la mesure
des émissions otoacoustiques (CEI 60645-6:2009)
Ta slovenski standard je istoveten z: EN 60645-6:2010
ICS:
17.140.50 Elektroakustika Electroacoustics
SIST EN 60645-6:2010 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 60645-6:2010

---------------------- Page: 2 ----------------------

SIST EN 60645-6:2010

EUROPEAN STANDARD
EN 60645-6

NORME EUROPÉENNE
January 2010
EUROPÄISCHE NORM

ICS 17.140.50


English version


Electroacoustics -
Audiometric equipment -
Part 6: Instruments for the measurement of otoacoustic emissions
(IEC 60645-6:2009)


Electroacoustique -  Akustik -
Appareillage audiométrique - Audiometer -
Partie 6: Instruments pour la mesure Teil 6: Geräte zur Messung
des émissions otoacoustiques von otoakustischen Emissionen
(CEI 60645-6:2009) (IEC 60645-6:2009)




This European Standard was approved by CENELEC on 2009-12-01. 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 Central Secretariat 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 Central Secretariat 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, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: Avenue Marnix 17, B - 1000 Brussels


© 2010 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60645-6:2010 E

---------------------- Page: 3 ----------------------

SIST EN 60645-6:2010
EN 60645-6:2010 - 2 -
Foreword
The text of document 29/673/FDIS, future edition 1 of IEC 60645-6, prepared by IEC TC 29,
Electroacoustics, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as
EN 60645-6 on 2009-12-01.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2010-09-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2012-12-01
Annex ZA has been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60645-6:2009 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 (not modified).
__________

---------------------- Page: 4 ----------------------

SIST EN 60645-6:2010
- 3 - EN 60645-6:2010
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications

The following referenced documents are indispensable for the application 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  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.

Publication Year Title EN/HD Year

1)
IEC 60318-4 - Electroacoustics - Simulators of human head EN 60318-4 200X
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 cm³ coupler for the measurement of
hearing aids and earphones coupled to the
ear by means of ear inserts


IEC 60601-1 - Medical electrical equipment - EN 60601-1 -
Part 1: General requirements for basic safety
and essential performance


IEC 60601-1-2 - Medical electrical equipment - EN 60601-1-2 -
(mod) Part 1-2: General requirements for basic
safety and essential performance - Collateral
standard: Electromagnetic compatibility -
Requirements and tests


IEC 60601-1-4 - Medical electrical equipment - EN 60601-1-4 -
Part 1-4: General requirements for safety -
Collateral standard: Programmable electrical
medical systems


IEC 60645-1 2001 Electroacoustics - Audiological equipment - EN 60645-1 2001
Part 1: Pure-tone audiometers


IEC 60645-3 2007 Electroacoustics - Audiometric equipment - EN 60645-3 2007
Part 3: Test signals of short duration


ISO/IEC - Uncertainty of measurement - - -
Guide 98-3 Part 3: Guide to the expression of uncertainty
in measurement (GUM:1995)




1)
To be published.

---------------------- Page: 5 ----------------------

SIST EN 60645-6:2010

---------------------- Page: 6 ----------------------

SIST EN 60645-6:2010
IEC 60645-6
®
Edition 1.0 2009-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE


Electroacoustics – Audiometric equipment –
Part 6: Instruments for the measurement of otoacoustic emissions

Electroacoustique – Equipements audiométriques –
Partie 6: Instruments pour la mesure des émissions otoacoustiques

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
P
CODE PRIX
ICS 17.140.50 ISBN 2-8318-1038-3
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

---------------------- Page: 7 ----------------------

SIST EN 60645-6:2010
– 2 – 60645-6 © IEC:2009
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 Harmonic distortion .11
5.2 Test quality assuring system .11
5.2.1 General .11
5.2.2 Test quality assurance.11
5.2.3 Individual stimulus recordings.11
5.3 Measuring system .11
5.3.1 Units of measurement.11
5.3.2 Measurement range.11
5.3.3 Accuracy of measurement .11
5.3.4 Frequency range .11
5.3.5 Noise reduction .11
5.3.6 Response detection.12
5.3.7 Quality estimates.12
5.3.8 Normative values.12
5.4 Presentation of results .12
5.4.1 General .12
5.4.2 Primary results .12
5.4.3 Secondary results.13
6 Demonstration of conformity with specifications.13
6.1 General .13
6.2 Probe signal .13
6.2.1 Probe signal spectrum .13
6.2.2 Probe signal level and harmonic distortion.13
6.3 Maximum permitted expanded uncertainty of measurements U .13
max
6.4 Function of the complete system .14
7 General requirements .14
7.1 Marking .14
7.2 Instruction manual.14
7.3 Safety requirements .14
7.4 Immunity to power and radiofrequency fields .14
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

---------------------- Page: 8 ----------------------

SIST EN 60645-6:2010
60645-6 © IEC:2009 – 3 –
7.6.3 Environmental conditions.15
8 Additional characteristics to be specified by the manufacturer .15
9 Routine calibration .15
Bibliography.16

Table 1 – Mandatory functions for otoacoustic emission instruments .9
Table 2 – Documentation of test conditions, parameters and results .12
Table 3 – Values of U for basic measurements .14
max

---------------------- Page: 9 ----------------------

SIST EN 60645-6:2010
– 4 – 60645-6 © IEC:2009
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 provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
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.
International Standard IEC 60645-6 has been prepared by IEC technical committee 29:
Electroacoustics.
The text of this standard is based on the following documents:
FDIS Report on voting
29/673/FDIS 29/681/RVD

Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

---------------------- Page: 10 ----------------------

SIST EN 60645-6:2010
60645-6 © IEC:2009 – 5 –
The list of all the parts of the IEC 60645 series, under the general title Electroacoustics –
Audiometric equipment, can be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until
the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in
the data related to the specific publication. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.

---------------------- Page: 11 ----------------------

SIST EN 60645-6:2010
– 6 – 60645-6 © IEC:2009
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 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 other physiological or artificial
sources.

---------------------- Page: 12 ----------------------

SIST EN 60645-6:2010
60645-6 © IEC:2009 – 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 acoustic meatus evoked by acoustic probe
pulses or tones. This standard defines the characteristics to be specified by the manufacturer,
1
lays down performance specifications for two types of instruments and specifies the
functions to be provided on these types. This part of IEC 60645 describes methods of test to
be used for approval testing and guidance on methods for undertaking routine calibration.
The purpose of this part of IEC 60645 is to ensure th
...