EN 60645-6:2010

SLOVENSKI STANDARD
01-marec-2010
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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).
__________
- 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.
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
– 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

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
– 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
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