EN 60645-1:2015

Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone audiometry

IEC 60645-1:2012 specifies general requirements for audiometers and particular requirements for pure-tone audiometers designed for use in determining hearing threshold levels, relative to standard reference threshold levels established by means of psychoacoustic test methods. The object of this standard is to ensure: a) That tests of hearing in the frequency range 125 Hz to 16 000 Hz on a given human ear, performed with different audiometers which comply with this standard shall give substantially the same results; b) That the results obtained represent a valid comparison between the hearing of the ear tested and the reference threshold of hearing; c) That audiometers are classified according to the range of test signals they generate, according to the mode of operation or according to the complexity of the range of auditory functions they test. This third edition cancels and replaces the second edition, published in 2001, and IEC 60645-4 published in 1994. It constitutes an editorial revision.

Akustik - Audiometer - Teil 1: Reinton-Audiometer

Électroacoustique - Appareils audiométriques - Partie 1: Appareils pour l’audiométrie tonale

La CEI 60645-1:2012 spécifie des exigences générales applicables aux audiomètres et des exigences particulières applicables aux audiomètres tonaux conçus pour la détermination des seuils d'audition, par rapport aux seuils d'audition établis au moyen de méthodes d'essai psychoacoustiques. L'objet de la présente norme est de s'assurer: a) Que les essais d'audition effectués sur une oreille humaine donnée, dans le domaine des fréquences comprises entre 125 Hz et 16 000 Hz, avec différents audiomètres satisfaisant à la présente Norme, donnent obligatoirement sensiblement les mêmes résultats; b) Que les résultats obtenus représentent une comparaison correcte entre l'audition de l'oreille mesurée et le seuil d'audition de référence; c) Que les audiomètres sont classés conformément au domaine des signaux d'essai qu'ils produisent, à leur mode de fonctionnement ou à la complexité du domaine des fonctions auditives qu'ils peuvent examiner. Cette troisième édition annule et remplace la deuxième édition parue en 2001, et la CEI 60645-4 parue en 1994. Elle constitue une révision éditoriale.

Elektroakustika - 1. del: Oprema za avdiometrijo čistega tona

Ta del standarda IEC 60645 določa splošne zahteve za avdiometre in posebne zahteve za avdiometre čistega tona, zasnovane za določanje ravni pragov slišnosti relativno na standardne referenčne pragove slišnosti, določene s psihoakustičnimi preskusnimi metodami.
Cilj tega standarda je zagotoviti
a) da se s preskusi sluha v frekvenčnem razponu od 125 Hz do 16 000 Hz na danem človeškem ušesu, izvedenimi z različnimi avdiometri, ki so skladni s tem standardom, pridobi načeloma enake rezultate;
b) da pridobljeni rezultati predstavljajo veljavno primerjavo med sluhom testiranega ušesa in referenčnimi pragovi slišnosti;
c) da so avdiometri razvrščeni na podlagi razpona preskusnih signalov, ki jih proizvajajo, glede na način delovanja ali glede na kompleksnost razpona slušnih funkcij, ki jih testirajo.

General Information

• Status: Withdrawn
• Publication Date: 22-Jan-2015
• Withdrawal Date: 04-Nov-2017
• 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: 9960 - Withdrawal effective - Withdrawal
• Start Date: 06-Oct-2020
• Completion Date: 06-Oct-2020
• 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
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 60645-1:2015 - Electroacoustics - Part 1: Equipment for pure-tone audiometry

Relations

• Replaces: EN 60645-4:1995 - Audiometers - Part 4: Equipment for extended high-frequency audiometry
• Effective Date: 28-Jan-2023
• Replaces: EN 60645-1:2001 - Electroacoustics - Audiological equipment - Part 1: Pure-tone audiometers
• Effective Date: 28-Jan-2023
• Replaced By: EN 60645-1:2017 - Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone and speech audiometry
• Effective Date: 10-Oct-2017

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2015
1DGRPHãþD
SIST EN 60645-4:1999
(OHNWURDNXVWLNDGHO2SUHPD]DDYGLRPHWULMRþLVWHJDWRQD
Electroacoustics - Part 1: Equipment for pure-tone audiometry
Akustik - Audiometer - Teil 1: Reinton-Audiometer
Electroacoustique - Appareils audiométriques - Partie 1: Appareils pour l'audiométrie
tonale
Ta slovenski standard je istoveten z: EN 60645-1:2015
ICS:
17.140.50 Elektroakustika Electroacoustics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60645-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2015
ICS 17.140.50 Supersedes EN 60645-1:2001, EN 60645-4:1995
English Version
Electroacoustics - Audiometric equipment -
Part 1: Equipment for pure-tone audiometry
(IEC 60645-1:2012)
Électroacoustique - Appareils audiométriques -  Akustik - Audiometer -
Partie 1: Appareils pour l'audiométrie tonale Teil 1: Reinton-Audiometer
(IEC 60645-1:2012) (IEC 60645-1:2012)
This European Standard was approved by CENELEC on 2014-11-05. 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 CEN-CENELEC
Management Centre 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 CEN-CENELEC Management Centre 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60645-1:2015 E
Foreword
The text of document 29/754/FDIS, future edition 3 of IEC 60645-1, prepared by
IEC/TC 29 "Electroacoustics" was submitted to the IEC-CENELEC parallel vote and approved by
CENELEC as EN 60645-1:2015.
The following dates are fixed:
(dop) 2015-08-05
• latest date by which the document has to be
implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2017-11-05
standards conflicting with the
document have to be withdrawn
This document supersedes EN 60645-1:2001 and EN 60645-4:1995.

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This standard covers the Principle Elements of the Safety Objectives for Electrical Equipment
Designed for Use within Certain Voltage Limits (LVD - 2006/95/EC).

Endorsement notice
The text of the International Standard IEC 60645-1:2012 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:

IEC 61260 NOTE Harmonized as EN 61260.
ISO 389-9 NOTE Harmonized as EN ISO 389-9.

- 3 - EN 60645-1:2015
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.

NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu
Publication Year Title EN/HD Year

IEC 60268-3 -  Sound system equipment - EN 60268-3 -
Part 3: Amplifiers
IEC 60318-1 -  Electroacoustics - Simulators of human EN 60318-1 -
head and ear -
Part 1: Ear simulator for the measurement
of supra-aural and circumaural earphones
IEC 60318-3 -  Electroacoustics - Simulators of human EN 60318-3 -
head and ear -
Part 3: Acoustic coupler for the calibration
of supra-aural earphones used in
audiometry
IEC 60318-4 -  Electroacoustics - Simulators of human EN 60318-4 -
head 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 EN 60318-5 -
head 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 60318-6 -  Electroacoustics - Simulators of human EN 60318-6 -
head and ear -
Part 6: Mechanical coupler for the
measurements on bone vibrators
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 -
Part 1-2: General requirements for basic
safety and essential performance -
Collateral standard: Electromagnetic
disturbances - Requirements and tests
IEC 60645-2 -  Audiometers - EN 60645-2 -
Part 2: Equipment for speech audiometry
IEC 61672-1 -  Electroacoustics - Sound level meters - EN 61672-1 -
Part 1: Specifications
Publication Year Title EN/HD Year

ISO 266 -  Acoustics - Preferred frequencies EN ISO 266 -
ISO 389-1 -  Acoustics - Reference zero for the EN ISO 389-1 -
calibration of audiometric equipment -
Part 1: Reference equivalent threshold
sound pressure levels for pure tones and
supra-aural earphones
ISO 389-2 -  Acoustics - Reference zero for the EN ISO 389-2 -
calibration of audiometric equipment -
Part 2: Reference equivalent threshold
sound pressure levels for pure tones and
insert earphones
ISO 389-3 -  Acoustics - Reference zero for the EN ISO 389-3 -
calibration of audiometric equipment -
Part 3: Reference equivalent threshold
force levels for pure tones and bone
vibrators
ISO 389-4 1994 Acoustics - Reference zero for the EN ISO 389-4 1998
calibration of audiometric equipment -
Part 4: Reference levels for narrow-band
masking noise
ISO 389-5 -  Acoustics - Reference zero for the EN ISO 389-5 -
calibration of audiometric equipment -
Part 5: Reference equivalent threshold
sound pressure levels for pure tones
in the frequency range 8 kHz to 16 kHz
ISO 389-7 -  Acoustics - Reference zero for the EN ISO 389-7 -
calibration of audiometric equipment -
Part 7: Reference threshold of hearing
under free-field and diffuse-field listening
conditions
ISO 389-8 -  Acoustics - Reference zero for the EN ISO 389-8 -
calibration of audiometric equipment -
Part 8: Reference equivalent threshold
sound pressure levels for pure tones and
circumaural earphones
ISO 4869-1 -  Acoustics - Hearing protectors - EN 24869-1 -
Part 1: Subjective method for the
measurement of sound attenuation
ISO 8253-1 2010 Acoustics - Audiometric test methods - EN ISO 8253-1 2010
Part 1: Pure-tone air and bone conduction
audiometry
ISO 8253-2 -  Acoustics - Audiometric test methods - EN ISO 8253-2 -
Part 2: Sound field audiometry with pure-
tone and narrow-band test signals
ISO 8253-3 -  Acoustics - Audiometric test methods - EN ISO 8253-3 -
Part 3: Speech audiometry
IEC 60645-1 ®
Edition 3.0 2012-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Electroacoustics – Audiometric equipment –

Part 1: Equipment for pure-tone audiometry

Électroacoustique – Appareils audiométriques –

Partie 1: Appareils pour l’audiométrie tonale

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX V
ICS 17.140.50 ISBN 978-2-88912-915-7

– 2 – 60645-1 © IEC:2012
CONTENTS
FOREWORD . 5
INTRODUCTION . 7
1 Scope . 8
2 Normative references . 8
3 Terms and definitions . 9
4 Requirements for specific types of fixed frequency audiometer . 12
5 General requirements . 13
5.1 General safety requirements . 13
5.2 Acoustic safety requirements . 13
5.3 Environmental conditions . 13
5.4 Warm-up time . 13
5.5 Power supply variation . 13
5.5.1 Interruption of power supply . 13
5.5.2 Mains operation . 14
5.5.3 Battery operation . 14
5.5.4 Other power supplies . 14
5.6 Electromagnetic compatibility . 14
5.7 Unwanted sound . 14
5.7.1 General . 14
5.7.2 Unwanted sound from an earphone . 14
5.7.3 Unwanted sound from a bone vibrator . 14
5.7.4 Unwanted sound radiated by an audiometer . 15
5.8 Testing of automatic-recording audiometers . 15
5.9 Interface connections . 15
6 Test signals . 15
6.1 Pure tones . 15
6.1.1 Frequency range and hearing level range . 15
6.1.2 Frequency accuracy . 16
6.1.3 Total harmonic distortion . 16
6.1.4 Rate of frequency change . 17
6.2 Frequency modulation . 17
6.3 External signal source . 17
6.3.1 Signals . 17
6.3.2 Frequency response . 17
6.3.3 Electrical sensitivity . 18
6.3.4 Reference level for external signal source . 18
6.3.5 Operator to subject speech communication . 18
6.3.6 Subject to operator speech communication . 18
6.4 Masking sound . 18
6.4.1 General . 18
6.4.2 Narrow-band noise . 18
6.4.3 Other masking sound . 20
7 Transducers . 20
7.1 Type of transducers .
...