SIST EN 60645-1:2017

Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone and speech audiometry (IEC 60645-1:2017)

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

Electroacoustique - Appareils audiométriques - Partie 1: Appareils pour l'audiométrie tonale et vocale

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 - Avdiometrična oprema - 1. del: Oprema za avdiometrijo čistega tona in govorno avdiometrijo (IEC 60645-1:2017)

Standard IEC 60645-1:2012 določa splošne zahteve za avdiometre in posebne zahteve za avdiometre čistega tona, zasnovane za določanje ravni pragov slišnosti glede na standardne referenčne pragove slišnosti, določene s psihoakustičnimi preskusnimi metodami. Namen tega standarda je zagotoviti:  a) da se s preskusi sluha v frekvenčnem območju 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 preskušanega 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 preskušajo.  Ta tretja izdaja razveljavlja in nadomešča drugo izdajo, objavljeno leta 2001, ter standard IEC 60645-4, objavljen leta 1994. Ta izdaja je uredniška revizija.

General Information

• Status: Published
• Publication Date: 07-Nov-2017
• ICS: 17.140.50 - Electroacoustics
• Technical Committee: I11 - Imaginarni 11
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 13-Oct-2017
• Due Date: 18-Dec-2017
• Completion Date: 08-Nov-2017
• 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)
• Ref Project: EN 60645-1:2017 - Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone and speech audiometry

Relations

• Replaces: SIST EN 60645-1:2015 - Electroacoustics - Part 1: Equipment for pure-tone audiometry
• Effective Date: 10-Oct-2017
• Replaces: SIST EN 60645-2:2000 - Audiometers - Part 2: Equipment for speech audiometry
• Effective Date: 19-Dec-2017

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60645-1:2017
01-december-2017
1DGRPHãþD
SIST EN 60645-1:2015
(OHNWURDNXVWLND$YGLRPHWULþQDRSUHPDGHO2SUHPD]DDYGLRPHWULMRþLVWHJD
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Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone and speech
audiometry (IEC 60645-1:2017)
Ta slovenski standard je istoveten z: EN 60645-1:2017
ICS:
17.140.50 Elektroakustika Electroacoustics
SIST EN 60645-1:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60645-1:2017

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SIST EN 60645-1:2017


EUROPEAN STANDARD EN 60645-1

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2017
ICS 17.140.50 Supersedes EN 60645-1:2015
English Version
Electroacoustics - Audiometric equipment - Part 1: Equipment for
pure-tone and speech audiometry
(IEC 60645-1:2017)
Electroacoustique - Appareils audiométriques -  Akustik - Audiometer - Teil 1: Reinton-Audiometer
Partie 1: Appareils pour l'audiométrie tonale et vocale (IEC 60645-1:2017)
(IEC 60645-1:2017)
This European Standard was approved by CENELEC on 2017-04-18. 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, Serbia, 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
© 2017 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 60645-1:2017 E

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SIST EN 60645-1:2017
EN 60645-1:2017
European foreword
The text of document 29/927/FDIS, future edition 4 of IEC 60645-1, prepared by
IEC/TC 29 "Electroacoustics" was submitted to the IEC-CENELEC parallel vote and approved by
CENELEC as EN 60645-1:2017.

The following dates are fixed:
(dop) 2018-04-06
• 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) 2020-10-06
standards conflicting with the
document have to be withdrawn

This document supersedes EN 60645-1:2015.

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.

Endorsement notice
The text of the International Standard IEC 60645-1:2017 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:

ISO 389-9 NOTE Harmonized as EN ISO 389-9.
2

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SIST EN 60645-1:2017
EN 60645-1:2017
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications

The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 1 Where 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 60268-7 -  Sound system equipment - EN 60268-7 -
Part 7: Headphones and earphones
IEC 60268-17 -  Sound system equipment - HD 483.17 S1 -
Part 17: Standard volume indicators
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
3

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SIST EN 60645-1:2017
EN 60645-1:2017
Publication Year Title EN/HD Year

IEC 61260-1 -  Electroacoustics - Octave-band and EN 61260-1 -
fractional-octave-band filters -
Part 1: Specifications
IEC 61672-1 -  Electroacoustics - Sound level meters - EN 61672-1 -
Part 1: Specifications
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
vibratory 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

4

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SIST EN 60645-1:2017



IEC 60645-1

®


Edition 4.0 2017-03




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE











Electroacoustics – Audiometric equipment –

Part 1: Equipment for pure-tone and speech audiometry




Électroacoustique – Appareils audiométriques –

Partie 1: Appareils pour l’audiométrie tonale et vocale
















INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE


INTERNATIONALE




ICS 17.140.50 ISBN 978-2-8322-4079-3



Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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SIST EN 60645-1:2017
– 2 – IEC 60645-1:2017 © IEC 2017
CONTENTS
FOREWORD . 5
INTRODUCTION . 7
1 Scope . 8
2 Normative references . 8
3 Terms and definitions . 9
4 Requirements by type and class of audiometer . 13
5 General requirements . 15
5.1 General safety requirements . 15
5.2 Acoustic safety requirements . 15
5.3 Environmental conditions . 15
5.4 Warm-up time . 15
5.5 Power supply variation . 15
5.5.1 Interruption of power supply . 15
5.5.2 Mains operation . 15
5.5.3 Battery operation . 15
5.5.4 Other power supplies . 16
5.6 Electromagnetic compatibility . 16
5.7 Unwanted sound . 16
5.7.1 General . 16
5.7.2 Unwanted sound from and between any combination of transducers . 16
5.7.3 Unwanted sound from an earphone . 16
5.7.4 Unwanted sound from a bone vibrator. 16
5.7.5 Unwanted sound radiated by an audiometer . 17
5.8 Testing of automatic-recording audiometers . 17
5.9 Interface connections . 17
6 Test signals . 17
6.1 Speech signals . 17
6.1.1 Speech signal general requirements . 17
6.1.2 Free-field equivalent earphone output level . 17
6.1.3 Uncorrected earphone output level . 18
6.1.4 Loudspeaker output level . 18
6.1.5 Bone vibrator output level . 18
6.1.6 Speech signal frequency response . 18
6.1.7 Calibration signal . 18
6.1.8 Live voice microphone frequency response . 18
6.1.9 Scale reference and output level . 19
6.1.10 Distortion requirements for speech signals . 19
6.2 Pure tones . 20
6.2.1 Frequency range and hearing level range . 20
6.2.2 Frequency acceptance limits . 21
6.2.3 Total harmonic distortion . 21
6.2.4 Rate of frequency change . 21
6.2.5 Frequency modulation . 21
6.3 External signal sources . 22
6.3.1 Signals . 22
6.3.2 Frequency response . 22

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SIST EN 60645-1:2017
IEC 60645-1:2017 © IEC 2017 – 3 –
6.3.3 Playback device input . 22
6.3.4 Signal-to-noise ratio for playback device input . 22
6.3.5 Electrical sensitivity . 22
6.3.6 Reference level for external signal source . 23
6.4 Operator and test subject speech communication . 23
6.4.1 General . 23
6.4.2 Operator to test subject speech communication (talk-forward) . 23
6.4.3 Test subject to operator speech communication (talk-back) . 23
6.4.4 Operator to test subject speech communication for live voice speech
audiometry . 23
6.4.5 Test subject to operator speech communication for vocal response
speech audiometry . 24
6.5 Masking sound . 24
6.5.1 General . 24
6.5.2 Narrow-band noise . 24
6.5.3 Speech weighted noise . 26
6.5.4 Other masking sound . 26
7 Transducers . 26
7.1 Types of transducers . 26
7.2 Headband . 26
7.3 Loudspeaker . 26
8 Signal level control . 26
8.1 Marking of pure-tone and speech signal level controls . 26
8.2 Signal indicator . 27
8.3 Sound pressure level and vibratory force level acceptance limits . 27
8.4 Signal level control . 28
8.4.1 Manual audiometers . 28
8.4.2 Automatic-recording audiometers . 28
8.4.3 Signal level control acceptance limits . 28
8.5 Masking sound level control . 28
8.5.1 General . 28
8.5.2 Masking sound level . 28
8.5.3 Masking sound level acceptance limits . 29
8.5.4 Masking sound level range . 29
8.6 Signal switching . 29
8.6.1 Signal switch for manual audiometers . 29
8.6.2 On/off ratio for manual audiometers . 29
8.6.3 Rise/fall times for manual audiometers . 29
8.6.4 Automatic pulsed presentation . 30
8.6.5 Subject’s response system . 30
8.6.6 Subject’s response time for automated test procedures . 30
9 Reference tone . 31
9.1 General . 31
9.2 Frequencies . 31
9.3 Reference tone level control . 31
9.3.1 Range . 31
9.3.2 Intervals . 31
9.3.3 Marking . 31
9.3.4 Acceptance limits. 31

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SIST EN 60645-1:2017
– 4 – IEC 60645-1:2017 © IEC 2017
9.3.5 Operation . 31
10 Calibration . 31
11 Electrical output of test signals . 32
12 Audiogram format . 33
13 Test requirements to demonstrate conformity . 33
13.1 General . 33
13.2 Environmental conditions and power supply variation . 33
13.3 Electromagnetic compatibility . 34
13.4 Unwanted sound . 34
13.4.1 Unwanted sound from an earphone . 34
13.4.2 Unwanted sound from a bone vibrator. 35
13.4.3 Unwanted sound radiated by an audiometer . 35
13.5 Total harmonic distortion of test signals . 35
13.6 Microphone for live voice speech testing . 36
13.7 Signal accuracy . 36
13.7.1 Accuracy of sound pressure level and vibratory force level . 36
13.7.2 Accuracy of hearing level control . 36
13.8 Masking sound . 36
13.8.1 Narrow-band noise . 36
13.8.2 Masking sound level . 36
13.9 Headbands . 37
13.9.1 General . 37
13.9.2 Supra-aural and circumaural earphone headband . 37
13.9.3 Bone vibrator headband . 37
14 Maximum permitted expanded uncertainty of measurements U . 37
max
15 Marking and instruction manual . 38
15.1 Marking . 38
15.2 Instruction manual . 38
Annex A (informative) Relationship between tolerance interval, corresponding
acceptance interval and the maximum permitted uncertainty of measurement . 40
Bibliography . 41

Figure 1 – Rise/fall envelope of test tones . 30
Figure A.1 – Relationship between tolerance interval, corresponding acceptance
interval and the maximum permitted uncertainty of measurement . 40

Table 1 – Minimum facilities for audiometers . 14
Table 2 – Minimum number of frequencies to be provided and the minimum range of
values of hearing level for type and class of audiometer . 20
Table 3 – Maximum permissible acoustic total harmonic distortion, for supra-aural,
circumaural, insert earphones and bone vibrators . 21
Table 4 – Narrow-band masking noise: upper and lower cut-off frequencies for a
sound pressure spectrum density level of –3 dB referenced to the level at the centre
frequency of the band . 25
Table 5 – Standards specifying reference equivalent threshold levels . 32
Table 6 – Symbols for the graphical presentation of hearing threshold levels . 33
Table 7 – Values of U for basic measurements . 38
max

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SIST EN 60645-1:2017
IEC 60645-1:2017 © IEC 2017 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

ELECTROACOUSTICS – AUDIOMETRIC EQUIPMENT –

Part 1: Equipment for pure-tone and speech audiometry

FOREWORD
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international co-operation on all questions concerning standardization in the electrical and electronic fields. To
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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 60645-1 has been prepared by IEC technical committee 29:
Electroacoustics.
This fourth edition cancels and replaces the third edition, published in 2012, and the first
edition IEC 60645-2, published in 1993. This edition constitutes a technical revision.
This e
...