EN 60645-5:2005

Electroacoustics - Audiometric equipment - Part 5: Instruments for the measurement of aural acoustic impedance/admittance

Applies to instruments designed primarily for the measurement of acoustic impedance/admittance in the human external acoustic meatus using a stated probe tone. It is recognized that other probe signals may also be used. The standard defines the characteristics to be specified by the manufacturer, lays down performance specifications for three types of instruments and specifies the facilities to be provided on these types. This standard describes methods of test to be used for approval testing and guidance on methods for undertaking routine calibration. The purpose of this standard is to ensure that measurements made under comparable test conditions with different instruments complying with the standard will be consistent. The standard is not intended to restrict development or incorporation of new features, nor to discourage innovative approaches. This first edition of EN 60645-5 cancels and replaces the first edition of EN 61027, published in 1991, and constitutes a technical revision.

Akustik - Audiometer - Teil 5: Geräte zur Messung der akustischen Impedanzen/Admittanzen des Gehörs

Electroacoustique - Appareillage audiométrique - Partie 5: Instruments pour la mesure de l'impédance ou de l'admittance aurale (impédancemètres ou admittancemètres)

S'applique aux instruments conçus principalement pour la mesure de l'impédance ou de l'admittance acoustiques dans le conduit auditif humain en utilisant une sonde dont le signal présente une fréquence spécifiée. Il est admis que d'autres signaux de sonde peuvent également être utilisés. La norme définit les caractéristiques qui doivent être spécifiées par le fabricant, donne des spécifications concernant trois classes d'instruments et spécifie les possibilités qui doivent être offertes pour ces classes. La présente norme décrit des méthodes d'essai qui doivent être utilisées pour les essais d'approbation de modèle et donne un guide concernant les méthodes à utiliser pour entreprendre l'étalonnage périodique. L'objet de cette norme est de s'assurer que les mesures effectuées dans des conditions d'essais comparables, avec différents instruments satisfaisant à la norme, sont cohérentes. Il n'est pas dans les intentions de cette norme d'empêcher le développement de nouvelles possibilités ni de décourager les innovations. Cette première édition de la EN 60645-5 annule et remplace la première édition de la EN 61027, publiée en 1991, et constitue une révision technique.

Elektroakustika – Avdiometrična oprema – 5. del: Instrumenti za merjenje ušesne akustične impedance/admitance (IEC 60645-5:2004)

General Information

• Status: Published
• Publication Date: 06-Jan-2005
• Withdrawal Date: 30-Nov-2007
• ICS: 17.140.50 - Electroacoustics
• Technical Committee: CLC/SR 29 - Electroacoustics
• Drafting Committee: IEC/TC 29 - IEC_TC_29
• Parallel Committee: IEC/TC 29 - IEC_TC_29
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 07-Jan-2005
• Completion Date: 07-Jan-2005
• Ref Project: SIST EN 60645-5:2005 - Electroacoustics - Audiometric equipment -- Part 5: Instruments for the measurement of aural acoustic impedance/admittance

Relations

• Replaces: EN 61027:1993 - Instruments for the measurement of aural acoustic impedance/admittance
• Effective Date: 29-Jan-2023

Standards Content (Sample)

SLOVENSKI SIST EN 60645-5:2005

STANDARD
december 2005
Elektroakustika – Avdiometrična oprema – 5. del: Instrumenti za merjenje
ušesne akustične impedance/admitance (IEC 60645-5:2004)
Electroacoustics – Audiometric equipment – Part 5: Instruments for the
measurement of aural acoustic impedance/admittance (IEC 60645-5:2004)
ICS 17.140.50 Referenčna številka
©  Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno

EUROPEAN STANDARD EN 60645-5
NORME EUROPÉENNE
EUROPÄISCHE NORM January 2005

ICS 17.140.50 Supersedes EN 61027:1993

English version
Electroacoustics –
Audiometric equipment
Part 5: Instruments for the measurement
of aural acoustic impedance/admittance
(IEC 60645-5:2004)
Electroacoustique –  Akustik –
Appareillage audiométrique Audiometer
Partie 5: Instruments pour la mesure Teil 5: Geräte zur Messung der
de l'impédance ou de l'admittance aurale akustischen Impedanzen/Admittanzen
(impédancemètres ou admittancemètres) des Gehörs
(CEI 60645-5:2004) (IEC 60645-5:2004)

This European Standard was approved by CENELEC on 2004-12-01. 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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden,
Switzerland and United Kingdom.

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

Central Secretariat: rue de Stassart 35, B - 1050 Brussels

© 2005 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.

Ref. No. EN 60645-5:2005 E
Foreword
The text of document 29/563/FDIS, future edition 1 of IEC 60645-5, prepared by IEC TC 29,
Electroacoustics, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC
as EN 60645-5 on 2004-12-01.
This European Standard supersedes EN 61027:1993.
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) 2005-09-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2007-12-01
Annex ZA has been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60645-5:2004 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
ISO 389-1 NOTE Harmonized as EN ISO 389-1:2000 (not modified).
ISO 389-2 NOTE Harmonized as EN ISO 389-2:1996 (not modified).
__________
- 3 - EN 60645-5:2005
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 Where an international publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
Publication Year Title EN/HD Year
1) 2)
IEC 60126 - IEC reference coupler for the HD 305 S1 1977
measurement of hearing aids using
earphones coupled to the ear by means
of ear inserts
1) 2)
IEC 60601-1 - Medical electrical equipment EN 60601-1 1990
Part 1: General requirements for safety

1) 2)
IEC 60601-1-2 - Medical electrical equipment EN 60601-1-2 2001
Part 1-2: General requirements for safety
- Collateral standard: Electromagnetic
compatibility - Requirements and tests

1) 2)
IEC 60601-1-4 - Medical electrical equipment EN 60601-1-4 1996
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
1)
BIPM/IEC/IFCC/ - Guide to the expression of uncertainty in - -
ISO/IUPAP/OIML measurement (GUM)

1)
Undated reference.
2)
Valid edition at date of issue.

NORME CEI
INTERNATIONALE
IEC
60645-5
INTERNATIONAL
Première édition
STANDARD
First edition
2004-11
Electroacoustique –
Appareillage audiométrique –
Partie 5:
Instruments pour la mesure de l'impédance
ou de l'admittance aurale (impédancemètres
ou admittancemètres)
Electroacoustics –
Audiometric equipment –
Part 5:
Instruments for the measurement
of aural acoustic impedance/admittance

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Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in any
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électronique ou mécanique, y compris la photocopie et les photocopying and microfilm, without permission in writing from
microfilms, sans l'accord écrit de l'éditeur. the publisher.
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60645-5  IEC:2004 – 3 –
CONTENTS
FOREWORD.5
INTRODUCTION.9
1 Scope.11
2 Normative references.11
3 Terms and definitions .13
4 Requirements for specific instruments .19
5 General specifications.21
5.1 Measuring system.21
5.2 Pneumatic system.23
5.3 Acoustic reflex activating stimulus system .25
6 Demonstration of conformity with specifications.29
6.1 General.29
6.2 Impedance/admittance measuring system .29
6.3 Probe signal.29
6.4 Pneumatic system.31
6.5 Acoustic reflex activating stimulus signals .31
6.6 Maximum permitted expanded uncertainty of measurements .33
7 Calibration cavities.35
7.1 General.35
7.2 Dimensions of calibration cavities.35
7.3 Material of calibration cavity walls .35
7.4 Connection of probe to a calibration cavity .35
8 General requirements.35
8.1 Marking.35
8.2 Instruction manual.35
8.3 Safety requirements.35
8.4 Warm-up time.37
8.5 Supply variation and environmental conditions .37
8.6 Unwanted acoustic signals and radiation .37
9 Symbols, forms and formats for acoustic impedance/admittance data.39
9.1 Symbols for indicating measured quantities.39
9.2 Tympanogram format.39
9.3 Acoustic reflex test format .39
9.4 Eustachian tube function test format.41
10 Additional characteristics to be specified by the manufacturer .41
10.1 Aural impedance/admittance measurement system .41
10.2 Pneumatic system.43
10.3 Acoustic reflex activating stimulus system .45
10.4 Analogue electrical output .45
Annex A (informative) Routine calibration .47
Annex B (informative) Units and terms.49
Annex C (informative) Overall temporal characteristics .53
Bibliography.57

60645-5  IEC:2004 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
ELECTROACOUSTICS –
AUDIOMETRIC EQUIPMENT –
Part 5: Instruments for the measurement
of aural acoustic impedance/admittance

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