SIST EN 60645-1:2015

SLOVENSKI STANDARD
SIST EN 60645-1:2015
01-september-2015
1DGRPHãþD
SIST EN 60645-4:1999
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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
SIST EN 60645-1:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60645-1:2015

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SIST EN 60645-1:2015


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

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SIST EN 60645-1:2015
EN 60645-1:2015 - 2 -
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.

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SIST EN 60645-1:2015
- 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

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SIST EN 60645-1:2015
EN 60645-1:2015 - 4 -
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

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SIST EN 60645-1:2015



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



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 60645-1:2015
– 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 . 20
7.2 Headband. 20

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SIST EN 60645-1:2015
60645-1 © IEC:2012 – 3 –
7.3 Loudspeaker . 20
8 Signal level control . 20
8.1 Marking . 20
8.2 Signal indicator . 20
8.3 Accuracy of sound pressure level and vibratory force level . 21
8.4 Hearing level control . 21
8.4.1 Manual audiometers . 21
8.4.2 Automatic-recording audiometers . 21
8.4.3 Accuracy of control . 21
8.5 Masking level control . 22
8.5.1 General . 22
8.5.2 Masking level . 22
8.5.3 Accuracy of masking levels. 22
8.5.4 Masking level range . 22
8.6 Tone switching . 22
8.6.1 Tone switch for manual audiometers . 22
8.6.2 On/off ratio for manual audiometers . 22
8.6.3 Rise/fall times for manual audiometers . 23
8.6.4 Automatic pulsed presentation . 23
8.6.5 Subject’s response time for automated test procedures . 24
8.6.6 Subject’s response system . 24
9 Reference tone . 24
9.1 General . 24
9.2 Frequencies . 24
9.3 Reference tone level control . 25
9.3.1 Range . 25
9.3.2 Intervals . 25
9.3.3 Marking . 25
9.3.4 Accuracy . 25
9.3.5 Operation . 25
10 Calibration . 25
11 Electrical output of test signals . 26
12 Audiogram format . 26
13 Test requirements to demonstrate conformity . 27
13.1 General . 27
13.2 Environmental conditions and power supply variation . 27
13.3 Electromagnetic compatibility . 27
13.4 Unwanted sound . 28
13.4.1 Unwanted sound from an earphone . 28
13.4.2 Unwanted sound from a bone vibrator . 28
13.4.3 Unwanted sound radiated by an audiometer . 29
13.5 Total harmonic distortion of test signals . 29
13.6 Signal accuracy . 29
13.6.1 Accuracy of sound pressure level and vibratory force level . 29
13.6.2 Accuracy of hearing level control . 29
13.7 Masking sound . 29
13.7.1 Narrow-band noise . 29
13.7.2 Masking level . 30

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SIST EN 60645-1:2015
– 4 – 60645-1 © IEC:2012
13.8 Headbands . 30
13.8.1 General . 30
13.8.2 Supra-aural and circumaural earphone headband . 30
13.8.3 Bone vibrator headband . 30
14 Maximum permitted expanded uncertainty of measurements U . 30
max
15 Marking and instruction manual . 31
15.1 Marking . 31
15.2 Instruction manual . 31
Bibliography . 33

Figure 1 – Rise/fall envelope of test tones . 24

Table 1 – Minimum facilities for fixed-frequency audiometers . 12
Table 2 – Minimum number of frequencies to be provided and the minimum range of
values of hearing level for fixed frequency audiometers . 15
Table 3 – Minimum range of values of hearing level for EHF audiometers . 16
Table 4 – Maximum permissible acoustic total harmonic distortion, for supra-aural,

circumaural, insert earphones and bone vibrators . 17
Table 5 – Narrow-band masking noise: upper and lower cut-off frequencies for a
sound pressure spectrum density level of –3 dB referred to the level at the centre
frequency of the band . 19
Table 6 – Reference standards for obtaining audiometric zero . 26
Table 7 – Symbols for the graphical presentation of hearing threshold levels . 26
Table 8 – Values of U for basic measurements . 31
max

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SIST EN 60645-1:2015
60645-1 © IEC:2012 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

ELECTROACOUSTICS –
AUDIOMETRIC EQUIPMENT –

Part 1: Equipment for pure-tone audiometry

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
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 third edition cancels and replaces the second edition, published in 2001, and
IEC 60645-4 published in 1994. It constitutes an editorial revision.
The text of this standard is based on the following documents:
FDIS Report on voting
29/754/FDIS 29/757/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.

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SIST EN 60645-1:2015
– 6 – 60645-1 © IEC:2012
A list of all parts of the IEC 60645 series can be found, under the general title
Electroacoustics, on the IEC website.
Future standard in this series will carry the new general title as cited above. Titles of existing
standards in this series will be updated at the time of the next edition.
The committee has decided that the contents of this publication will remain unchanged until
the stability 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.

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SIST EN 60645-1:2015
60645-1 © IEC:2012 – 7 –
INTRODUCTION
Developments in the field of hearing measurements for diagnostic, hearing conservation and
rehabilitation purposes have resulted in the availability of a wide range of audiometers. In
addition it is possible to consider the audiometer in terms of a set of functional units which
can be specified independently. By specifying these functional units it is then possible to
specify the performance of other audiometric equipment which use these units. IEC 60645
series consists of a number of parts. IEC 60645-1 is the first in the series and covers the
requirements for pure tone audiometers.
This standard describes equipment which is designed for the measurement of hearing in the
frequency range from 125 Hz to 16 000 Hz.
Due to the development of the later parts of IEC 60645, no reference is now made in part 1 to
the use of broad-band noise for masking. Requirements for broad-band masking noise now
only relate to its use with speech signals as described in IEC 60645-2.
The test requirements to demonstrate conformity are now specified separately. Conformance
to the specifications in this standard is demonstrated only when the result of a measurement,
extended by the actual expanded uncertainty of measurement of the testing laboratory, lies
fully within the tolerances specified in this standard. The tolerances that are to be met by the
manufacturer of an audiometer are essentially the same as in the first edition of IEC 60645-1,
while the tolerances as applicable to the testing of the audiometer are increased by U
max
compared with those of the previous edition.
IEC 60645 se
...