SIST EN 60645-7:2010

Electroacoustics - Audiometric equipment - Part 7: Instruments for the measurement of auditory evoked potentials (IEC 60645-7:2009)

This part of IEC 60645 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. This part of IEC 60645 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 this part of IEC 60645 is to ensure that measurements made under comparable test conditions with different instruments complying with this standard will be consistent. This part of IEC 60645 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.

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)

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.

Elektroakustika - Avdiometrična oprema - 7. del: Instrumenti za merjenje slušnih potencialov (IEC 60645-7:2009)

Ta del IEC 60645 velja za instrumente za merjenje slušnih potencialov notranjega ušesa, slušnega živca in možganskega debla, ki jih izvabijo kratkotrajni akustični in/ali vibracijski dražljaji. Ta del IEC 60645 določa lastnosti, ki jih mora navesti proizvajalec, predpisuje specifikacije zmogljivosti za dve vrsti instrumentov, presejanje in diagnostiko in določa funkcije, ki jih morata ti vrsti izpolnjevati. Namen tega dela IEC 60645 je zagotoviti, da so meritve, ki se opravljajo pod primerljivimi preskusnimi pogoji z različnimi instrumenti v skladu s tem standardom, med seboj skladne. Ta standard ni namenjen ne omejevanju razvoja ali vključevanju novih funkcij ne odvračanju od inovativnih pristopov. Uporaba električnih dražljajev za posebne namene presega področje uporabe tega standarda.

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 60645-7:2010 - Electroacoustics - Audiometric equipment - Part 7: Instruments for the measurement of auditory brainstem responses

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60645-7:2010
01-marec-2010
(OHNWURDNXVWLND$YGLRPHWULþQDRSUHPDGHO,QVWUXPHQWL]DPHUMHQMHVOXãQLK
SRWHQFLDORY,(&
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
SIST EN 60645-7:2010 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60645-7:2010

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SIST EN 60645-7:2010

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

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SIST EN 60645-7:2010
EN 60645-7:2010 - 2 -
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).
__________

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SIST EN 60645-7:2010
- 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)

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SIST EN 60645-7:2010

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SIST EN 60645-7:2010
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
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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SIST EN 60645-7:2010
– 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

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SIST EN 60645-7:2010
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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