EN 60645-7:2010

SLOVENSKI STANDARD
01-marec-2010
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Electroacoustics - Audiometric equipment - Part 7: Instruments for the measurement of
auditory evoked potentials (IEC 60645-7:2009)
Akustik - Audiometer - Teil 7: Geräte zur Messung von akustisch evozierten Potentialen
(IEC 60645-7:2009)
Electroacoustique - Appareillage audiométrique - Partie 7: Instruments pour la mesure
des potentiels évoqués auditifs (CEI 60645-7:2009)
Ta slovenski standard je istoveten z: EN 60645-7:2010
ICS:
17.140.50 Elektroakustika Electroacoustics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 60645-7
NORME EUROPÉENNE
January 2010
EUROPÄISCHE NORM
ICS 17.140.50
English version
Electroacoustics -
Audiometric equipment -
Part 7: Instruments for the measurement of auditory brainstem responses
(IEC 60645-7:2009)
Electroacoustique -  Akustik -
Appareillage audiométrique - Audiometer -
Partie 7: Instruments pour la mesure Teil 7: Geräte zur Messung
des réponses du tronc cérébral von akustisch evozierten Potentialen
à une stimulation auditive (IEC 60645-7:2009)
(CEI 60645-7:2009)
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 60645-7:2010 E
Foreword
The text of document 29/674/FDIS, future edition 1 of IEC 60645-7, prepared by IEC TC 29,
Electroacoustics, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as
EN 60645-7 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 60645-7:2009 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:
IEC 60601-2-40 NOTE  Harmonized as EN 60601-2-40 (not modified).
__________
- 3 - EN 60645-7:2010
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

IEC 60601-1 - Medical electrical equipment - EN 60601-1 -
Part 1: General requirements for basic safety
and essential performance
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 389 Series Acoustics - Reference zero for the calibration - -
of audiometric equipment
ISO/IEC - Uncertainty of measurement - - -
Guide 98-3 Part 3: Guide to the expression of uncertainty
in measurement (GUM:1995)
IEC 60645-7 ®
Edition 1.0 2009-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Electroacoustics – Audiometric equipment –
Part 7: Instruments for the measurement of auditory brainstem responses

Electroacoustique – Equipements audiométriques –
Partie 7: Instruments pour la mesure des réponses du tronc cérébral à une
stimulation auditive
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
M
CODE PRIX
ICS 17.140.50 ISBN 2-8318-1038-4
– 2 – 60645-7 © IEC:2009
CONTENTS
FOREWORD.3
INTRODUCTION.5
1 Scope.6
2 Normative references .6
3 Terms and definitions .6
4 Requirements for specific instruments .7
5 General specifications .8
5.1 Measuring system .8
5.1.1 Units of measurement.8
5.1.2 Measurement range.8
5.1.3 Time resolution.8
5.2 Stimulus system .8
5.2.1 General requirements .8
5.2.2 Stimulus types .8
5.3 Test quality assuring system .8
5.3.1 Recording conditions .8
5.3.2 Response detection.9
5.3.3 Quality estimates.9
5.3.4 Reference values.9
5.4 Presentation of results .9
6 Demonstration of conformity with specifications.9
6.1 General .9
6.2 Signal-to-noise ratio improvement .9
6.3 Maximum permitted expanded uncertainty of measurements U .9
max
7 General requirements .10
7.1 Marking .10
7.2 Instruction manual.10
7.3 Safety requirements .10
7.3.1 General .10
7.3.2 Immunity to power and radiofrequency fields .10
7.4 Warm-up time.10
7.5 Voltage supply variation and environmental conditions .11
7.5.1 Mains operation.11
7.5.2 Battery operation .11
7.5.3 Environmental conditions.11
8 Routine calibration .11
Bibliography.12

Table 1 – Instrumentation requirements .7
Table 2 – Documentation of test conditions, parameters and results .9
Table 3 – Values of U for basic measurements .10
max
60645-7 © IEC:2009 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
_____________
ELECTROACOUSTICS –
AUDIOMETRIC EQUIPMENT –
Part 7: Instruments for the measurement
of auditory brainstem responses

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
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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 60645-7 has been prepared by IEC technical committee 29:
Electroacoustics.
The text of this standard is based on the following documents:
FDIS Report on voting
29/674/FDIS 29/682/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.

– 4 – 60645-7 © IEC:2009
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