As IEC 60645.1-2002 Electroacoustics - Audiological Equipment Pure-Tone Audiometers (IEC 60645-1-2001 MOD)
As IEC 60645.1-2002 Electroacoustics - Audiological Equipment Pure-Tone Audiometers (IEC 60645-1-2001 MOD)
As IEC 60645.1-2002 Electroacoustics - Audiological Equipment Pure-Tone Audiometers (IEC 60645-1-2001 MOD)
1—2002
AS IEC 60645.1
Australian Standard™
This is a free 9 page sample. Access the full version at http://infostore.saiglobal.com.
Electroacoustics—Audiological
equipment
Australian Standard™
This is a free 9 page sample. Access the full version at http://infostore.saiglobal.com.
Electroacoustics—Audiological
equipment
COPYRIGHT
© Standards Australia International
All rights are reserved. No part of this work may be reproduced or copied in any form or by any
means, electronic or mechanical, including photocopying, without the written permission of the
publisher.
Published by Standards Australia International Ltd
GPO Box 5420, Sydney, NSW 2001, Australia
ISBN 0 7337 4959 3
ii
PREFACE
This Standard was prepared by the Australian members of the Joint Standards Australia/Standards
New Zealand Committee AV-003, Acoustics Human Effects to be used as a means to demonstrate
compliance with the relevant essential principles in new medical device legislation.
After consultation with stakeholders in both countries, Standards Australia and Standards New
Zealand decided to develop this Standard as an Australian, rather than an Australian/New Zealand
Standard.
This Standard is an adoption with national modifications and has been reproduced from
IEC 60645-1:2001, Electroacoustics—Audiological equipment, Part 1: Pure-tone audiometers.
Variations to the IEC text for application in Australia are listed below and the affected text is
indicated by a marginal bar.
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Committee AV-003 considered that particular sound levels set in IEC 60645-1 were insufficient to
demonstrate conformity.
As this Standard is reproduced from an International Standard, the following applies:
(a) Its number does not appear on each page of text and its identity is shown only on the cover and
title page.
(b) In the source text ‘this part of IEC 60645’ should read ‘this Australian Standard’.
(c) A full point substitutes for a comma when referring to a decimal marker.
(d) In Clause 13.6.1, delete the existing text ‘70 dB’, and replace with ‘80 dB’. Delete the existing
text ‘30 dB or the maximum, which is lower’, and replace with ‘30 dB or at a level sufficient to
demonstrate conformity’.
(e) In Clause 13.7.2, delete the existing text ‘70 dB’ and replace with ‘80 dB’.
The objective of this Standard is to specify general requirements for audiometers and particular
requirements for pure-tone audiometers designed for use in determining hearing threshold levels, in
comparison with standard reference threshold levels by means of psychoacoustic test methods.
This Standard provides for the use of the following Australian/New Zealand Standards as equivalents
to particular International Standards referenced herein:
Reference to International Standard Australian/New Zealand Standard
IEC AS/NZS
60601 Medical electrical equipment 3200 Medical electrical equipment
60601-1 Part 1: General requirements for safety 3200.1.0 General requirements for safety—Parent
Standard
60601-1-2 Part 1-2: General requirements for 3200.1.2 Part 1.2: General requirements for
safety—Collateral Standard: safety—Collateral Standard:
Electromagnetic compatibility— Electromagnetic compatibility—
Requirements and tests Requirements and tests
ISO AS/NZS
389 Acoustics—Reference zero for the 1591 Acoustics—Instrumentation for
calibration of audiometric equipment audiometry
389-3 Part 3: Reference equivalent threshold 1591.1 Part 1: Reference zero for the
force levels for pure tones and bone calibration of pure-tone bone
vibrators conduction audiometers
iii
CONTENTS
INTRODUCTION .................................................................................................................. iv
Bibliography ......................................................................................................................... 28
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 uses these units. IEC 60645
consists of a number of parts. IEC 60645-1 is the first in the series and covers the
requirements for pure tone audiometers.
Due to the development of the later parts of IEC 60645, part 1 now confines its scope solely
to the requirements of pure tone audiometers. One consequence of this is that no reference is
now made to the use of broad-band noise for masking. Requirements for broad-band masking
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noise now only relate to its use with speech signals as described in IEC 60645-2.
This second edition now specifies performance requirements separate from the test
requirements to show conformity. Conformance to the specifications in this International
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 International Standard extended by the values for U max given in table 7. By
this, 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 use
of the audiometer are increased by U max compared with those of the previous edition.
1
AUSTRALIAN STANDARD
Electroacoustics—Audiological equipment
Part 1:
Pure-tone audiometers (IEC 60645-1:2001, MOD)
This part of IEC 60645 specifies general requirements for audiometers and particular
requirements for pure-tone audiometers designed for use in determining hearing threshold
levels, in comparison with standard reference threshold levels by means of psychoacoustic
test methods.
This is a free 9 page sample. Access the full version at http://infostore.saiglobal.com.
a) that tests of hearing, particularly threshold, in the frequency range 125 Hz to 8 000 Hz on
a given human ear performed with different audiometers which comply with this
International Standard using methods described in ISO 8253-1 and ISO 6189 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.
2 Normative references
The following normative documents contain provisions which, through reference in this text,
constitute provisions of this part of IEC 60645. For dated references, subsequent amend-
ments to, or revisions of, any of these publications do not apply. However, parties to
agreements based on this part of IEC 60645 are encouraged to investigate the possibility of
applying the most recent editions of the normative documents indicated below. For undated
references, the latest edition of the normative document referred to applies. Members of ISO
and IEC maintain registers of currently valid International Standards.
IEC 60126, IEC reference coupler for the measurement of hearing aids using earphones
coupled to the ear by means of ear inserts
IEC 60318-1, Electroacoustics – Simulators of human head and ear – Part 1: Ear simulator for
the calibration of supra-aural earphones
IEC 60318-2, Electroacoustics – Simulators of human head and ear – Part 2: An interim
acoustic coupler for the calibration of audiometric earphones in the extended high frequency
range
IEC 60318-3, Electroacoustics – Simulators of human head and ear – Part 3: Acoustic coupler
for the calibration of supra-aural earphones used in audiometry
IEC 60601-1, Medical electrical equipment – Part 1: General requirements for safety