IEC 60645-7:2009

Electroacoustics - Audiometric equipment - Part 7: Instruments for the measurement of auditory brainstem responses

IEC 60645-7:2009 applies to instruments designed for the measurement of auditory evoked potentials from the inner ear, the auditory nerve and the brainstem, evoked by acoustic and/or vibratory stimuli of short duration. IEC 60645-7:2009 defines the characteristics to be specified by the manufacturer, specifies performance requirements for two types of instrument, screening and diagnostic, and specifies the functions to be provided on these types. The purpose of IEC 60645-7:2009 is to ensure that measurements made under comparable test conditions with different instruments complying with this standard will be consistent. IEC 60645-7:2009 is not intended to restrict development or incorporation of new features, nor to discourage innovative approaches. The application of electric stimuli for special purposes is beyond the scope of this standard.

Electroacoustique - Equipements audiométriques - Partie 7: Instruments pour la mesure des réponses du tronc cérébral à une stimulation auditive

La CEI 60645-7:2009 s'applique aux instruments conçus pour la mesure audiologique des potentiels évoqués de l'oreille interne, du nerf auditif et du tronc cérébral, évoqués par des stimuli acoustiques et/ou vibratoires de courte durée. La CEI 60645-7:2009 définit les caractéristiques qui doivent être spécifiées par le fabricant, spécifie les exigences de performances pour deux types d'instrument, le dépistage et le diagnostic, et spécifie les fonctions à prévoir sur ces deux types. La CEI 60645-7:2009 est destinée à assurer que les mesures réalisées dans des conditions d'essai comparables avec différents instruments conformes à la présente norme seront cohérentes. La CEI 60645-7:2009 n'est pas destinée à limiter le développement ou l'ajout de nouvelles caractéristiques ni à décourager les approches innovantes. L'application de stimuli électriques pour des usages particuliers n'entre pas dans le domaine d'application de la présente norme.

General Information

• Status: Published
• Publication Date: 28-Apr-2009
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 17.140.50 - Electroacoustics
• Technical Committee: TC 29 - Electroacoustics
• Drafting Committee: WG 10 - TC 29/WG 10
• Current Stage: PPUB - Publication issued
• Start Date: 15-May-2009
• Completion Date: 29-Apr-2009

Standards Content (Sample)

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
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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 978-2-88910-243-3
– 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
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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
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.
60645-7 © IEC:2009 – 5 –
INTRODUCTION
Developments in the field of diagn
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