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1、J IS JAPANESE INDUSTRIAL STANDARD Translated and Published by Japanese Standards Association JIS T 1201-1:2000 Audiometers- Part 1 : Pure-tone audiometers ICs 17.140.50 Descriptors : audiometers, auditory threshold, hearing (auditory perception), testing Reference number : JIS T 1201-1 : 2000 (E) PR
2、OTECTED BY COPYRIGHT 28 S Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007 21:01:10 MDTNo reproduction or networking permitted without license from IHS -,-,- T 1201-1 : 2000 (IEC 60645-1 199
3、2) Foreword This translation has been made based on the original Japanese Industrial Standard established by the Minister of International Trade and Industry and the Minister of Health and Welfare through deliberations at the Japanese Industrial Standards Committee in accordance with the Industrial
4、Standardization Law. In order to conform to the International Standard, this Standard has been prepared based on IEC 60645-1 : 1992 without modifying the technical contents. In addition, annexes 1 to 6 (normative) have been respectively prepared based on IS0 389 : 1991, IS0 389-3 : 1994, IS0 389-4 :
5、 1994, IEC 60303 : 1970, IEC 60318 : 1970 and IEC 60373 : 1990 without modifying the technical contents. JIS T 1201 consists of the following 2 parts: Part 1 : Pure-tone audiometers Part 2 :Equipment for speech audiometry Date of Establishment: 2000-08-01 Date of Public Notice in Official Gazette: 2
6、000-08-01 Investigated by: Japanese Industrial Standards Committee Divisional Council on Medical and Safety JIS T 1201-1 :2000, First English edition published in 2005-07 Translated and published by: Japanese Standards Association 4-1-24, Akasaka, Minato-ku, Tokyo, 107-5440 JAPAN In the event of any
7、 doubts arising as to the contents, the original JIS is to be the final authority. O JSA 2005 All rights reserved. Unless otherwise specified, iio part of this publication may be reproduced or utilized in any forin or by any ineaiis, electronic or mechanical, includiiig photocopying and microfilm, w
8、ithout permission in writing from the publisher. Printed in Japan AT PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007 21:01:10 MDTNo reproduction or networking permitt
9、ed without license from IHS -,-,- JAPANESE INDUSTRIAL STANDARD JIS T 1201-1 : 2000 (IEC 60645-1 : 1992) Audio met ers- Part 1 : Pure-tone audiometers Introduction This Japanese Industrial Standard has been prepared based on the first edition of IEC 60645-1 Audiometers-Part 1 : Pure-tone audiometers
10、published in 1992 without modifying the technical contents. Portions underlined with dots are the matters not stated in the original Interna- tional Standard. 1 This part of JIS T 1201 specifies general requirements for audiometers and particular requirements for pure-tone audiometers designed for u
11、se in determining hearing threshold levels in comparison with the standard reference threshold level by means of psycho-acoustic test methods. Scope and object The purpose of this part is to ensure: a) that tests of hearing, particularly threshold, on a given human ear performed with different audio
12、meters which comply with this part using methods described in IS0 8253-1 and IS0 6189 (see clause 2) 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. Audiometers can be c
13、lassified in the following ways: according to the type of test signal they generate, according to the mode of operation or according to the com- plexity of the range of auditory functions they test (i.e. diagnostic, screening, etc.). However, in order to rationalize the classification of audiometers
14、, five types are defined. Audiometers with which it is possible to make a diagnostic assessment (Le. hav- ing as a minimum both air and bone conduction facilities) are classified as types 1, 2 and 3. Instruments with air conduction facilities only are classified as types 4 and 5. This part covers th
15、e general requirements for audiometers as a whole as well as their functional units: signal sources, signal level controls and transducers (earphones and bone vibrators). . . . . . . . . . . . . . . . . . . . . . In addition, since the units specified cover the majority of audiometric applica- tions
16、, instruments which may not necessarily be conventional pure-tone audiometers and not specified in this part (such as an auditory stimulator for evoked potential recording), but which contain circuitry used for measurement of auditory sensitivity or presentation of supraliminal signals should, where
17、 possible, conform to the ap- propriate clauses of this part. By using table 1, the reader can find the appropriate clauses (5 to 9) of this part which describe the performance requirements for a given instrument. PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under
18、license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007 21:01:10 MDTNo reproduction or networking permitted without license from IHS -,-,- 2 T 1201-1 : 2000 (IEC 60645-1 : 1992) Table 1 Guide to the requirements for various parts of an audiometer General requi
19、rements 5.1 Safety requirements 5.2 Subjects response 5.3 Warm-up time 5.4 Supply variation system and environmental conditions 5.5 Unwanted sound 10 Marking and instruction manual Requirements for signal sources 6.1 Pure tones 6.2 External signal 6.3 Masking sounds 8 Reference tone source Requireme
20、nts for signal level control 7.1 Marking 7.2 Signal indicator 7.3 Accuracy of sound pressure level and vibratory force level 7.4 Hearing level control 7.5 Masking sound 7.6 Tone switching Requirements for transducers (earphones and bone vibrators) 9.1 Air conduction 9.2 Bone conduction 2 Normative r
21、eferences The following standards contain provisions which, through reference in this text, constitute provisions of this Standard. If the indication of the year of coming into effect or the year of publication is given to these referred stan- dards, only the edition of indicated year constitutes th
22、e provision of this Standard but the revision and amendment made thereafter do not apply. The normative ref- erences without the indication of the year of coming into effect or the year of publi- cation apply only to the most recent edition. JIS C 1505 Precision sound level meters NOTE : Type 1 of I
23、EC 60651 : 1979 Sound level meters is equivalent to the said standard. JIS T 1001 NOTE : General requirements for safety of medical electrical equipment IEC 60601-1 : 1988 Medical electrical equipment-Part 1 : General re- quirements for safety is equivalent to the said standard. General rules of tes
24、ting methods for safety of medical electrical equip- ment IEC 60601-1 : 1988 Medical electrical equipment-Part 1 : General re- quirements for safety is equivalent to the said standard. IEC 60126 : 1973 IEC reference coupler for the measurement of hearing aids us- ing earphones coupled to the ear by
25、means of ear inserts JIS T 1002 NOTE : IEC 60268-3 : 1988 IEC 60711 : 1981 Occluded-ear simulator for the measurement of earphones coupled to the ear by ear inserts IEC 61260 : 1995 Electroacoustics-Octave-band and fractional-octave-band fil- ters Sound system equipment-Part 3 :Amplifiers Informatio
26、n : The above IEC Standard numbers are based on the new number- ing system of IEC Standards put in force on January 1st 1997, and the Standards published before the said date are numbered . PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee
27、=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007 21:01:10 MDTNo reproduction or networking permitted without license from IHS -,-,- 3 T 1201-1 : 2000 (IEC 60645-1 : 1992) IS0 389-2 : 1994 Acoustics-Reference zero for the calibration of audiometric equipment-Part 2 : Reference
28、equivalent threshold sound pres- sure levels for pure tones and insert earphones IS0 4869-1 : 1990 Acoustics-Hearing protectors-Part 1 : Subjective method for the measurement of sound attenuation Acoustics-Pure tone air conduction threshold audiometry for hearing conservation purposes IS0 8253-1 : 1
29、989 Acoustics-Audiometric test methods-Part 1 :Basic pure tone air and bone conduction threshold audiometry IS0 6189 : 1983 3 Definitions The definitions of term used in this Standard shall be as follows: 3.1 an instrument for the measurement of hearing for pure tones and in particular the threshold
30、 of hearing. The audiometer may be ei- ther a fixed or continuous sweep frequency type pure-tone audiometer 3.2 of results are performed manually manual audiometer an audiometer in which signal presentations and recording 3.3 automatic recording audiometer an audiometer in which signal presenta- tio
31、ns, hearing level variation, frequency selection or frequency variation, and recording of subjects responses are implemented automatically. Direction of hearing level changes is under subjects control and is recorded automatically 3.4 computer-controlled audiometer an audiometer in which the test pr
32、oce- dure is controlled by computer or microprocessor 3 . 5 test material speech audiometer an instrument for the measurement of hearing for speech 3.6 to the inner ear air conduction transmission of sound through the external and middle ear 3.7 by mechanical vibration of the cranial bones bone cond
33、uction transmission of sound to the inner ear mediated primarily 3.8 equivalent threshold sound pressure level (monaural earphone listen- ing) for a given ear, at a specified frequency, for a specified type of earphone and for a stated force of application of the earphone to a human ear, the sound p
34、ressure level set up by the earphone in a specified acoustic coupler or artificial ear when the earphone is activated by that voltage which, with the earphone applied to the ear concerned, would correspond to the threshold of hearing 3.9 for a given ear, at a specified frequency, for a Specified con
35、figuration of bone vibrator on a specified mechanical coupler, the force level set up by the bone vibrator in a specified me- chanical coupler when the bone vibrator is activated by that voltage which, with the bone vibrator applied to the mastoid prominence or to the forehead, would corre- spond to
36、 the threshold of hearing equivalent threshold force level (monaural listening) PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007 21:01:10 MDTNo reproduction or network
37、ing permitted without license from IHS -,-,- 4 T 1201-1 : 2000 (IEC 60645-1 : 1992) NOTE : This definition requires the non-test ear to be masked in accordance with annex 2. 3.10 reference equivalent threshold sound pressure level (RETSPL) at a specified frequency, the modal value of the equivalent
38、threshold sound pressure lev- els of a sufficiently large number of ears of otologically normal persons of both sexes aged between 18 and 30 years inclusive, expressing the threshold of hearing in a specified acoustic coupler or artificial ear for a specified type of earphone Values of reference equ
39、ivalent threshold sound pressure levels are speci- fied in annex 1. NOTE : 3.11 at a specified fre- quency, the mean value of the equivalent threshold force levels of a sufficiently large number of ears of otologically normal persons of both sexes aged between 18 and 30 years inclusive, expressing t
40、he threshold of hearing in a specified mechanical cou- pler for a specified configuration of bone vibrator NOTE : Values of reference equivalent threshold force levels are specified in annex 2. reference equivalent threshold force level (RETFL) 3.12 hearing level of a pure tone at a specified freque
41、ncy, for a specific type of transducer and for a specified manner of application, the sound pressure level or the vibratory force level of this signal set up by the transducer in a specified acous- tic or mechanical coupler or an artificial ear minus the appropriate reference equivalent threshold le
42、vel for air or bone conduction as applicable 3.13 hearing threshold level for pure tones the hearing threshold level of a given ear at a specified frequency is the threshold of hearing at that frequency ex- pressed as hearing level Methods of determining thresholds of hearing are specified in IS0 61
43、89 and IS0 8253-1. NOTE : 3.14 artificial ear; (ear simulator) device for the calibration of an earphone which presents to the earphone an acoustic impedance equivalent to the impedance pre- sented by the average human ear. It is equipped with a calibrated microphone for the measurement of the sound
44、 pressure developed by the earphone An artificial ear is specified in annex 5. NOTE : 3.15 cavity of predetermined shape and volume which is used for the calibration of an earphone in conjunction with a calibrated microphone to measure the sound pressure developed within the cavity NOTE : An acousti
45、c coupler is specified in annex 4. acoustic coupler 3.16 mechanical coupler device designed to present a specified mechanical im- pedance to a vibrator applied with a specified static force, and equipped with a mechano- electric transducer to enable the alternating force level at the surface of cont
46、act between vibrator and mechanical coupler to be determined NOTE : A mechanical coupler is specified in annex 6. PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007 21:0
47、1:10 MDTNo reproduction or networking permitted without license from IHS -,-,- 5 T 1201-1 : 2000 (IEC 60645-1 : 1992) 3.17 masking a) process by which the threshold of hearing of a sound is raised by the presence of another (masking) sound. the amount by which the hearing threshold level is so raise
48、d, expressed in deci- bels. b) 3.18 effective masking level the level of a specified masking sound which is nu- merically equal to that hearing level to which the tone threshold of the notional normal person would be raised by the presence of that masking sound. The notional normal person is one who
49、se hearing conforms to the standards for threshold and for mask- ing efficiency (annex 1 and annex 3) NOTES 1 Effective masking level is thus analogous to hearing level (see 3.12), that is, it is measure of sound on a physical scale, independent of a particular ear under test. 2 Reference values for effective masking are given in annex 3. 3.