EN 60645-1-2015 en Electroacoustics - Audiometric equipment - Part 1 Equipment for pure-tone audiometry.pdf

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1、BSI Standards PublicationElectroacoustics Audiometric equipmentPart 1: Equipment for pure-tone audiometryBS EN 60645-1:2015National forewordThis British Standard is the UK implementation of EN 60645-1:2015. It isidentical to IEC 60645-1:2012. It supersedes BS EN 60645-1:2001 and BS EN60645-4:1995, w

2、hich are withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee EPL/29, Electroacoustics.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions ofa contr

3、act. Users are responsible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 88221 0ICS 13.140; 17.140.50Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under t

4、he authority of theStandards Policy and Strategy Committee on 28 February 2015.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 60645-1:2015EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 60645-1 January 2015 ICS 17.140.50 Supersedes EN 60645-1:2001, EN 60645-4

5、:1995 English Version Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone audiometry (IEC 60645-1:2012) lectroacoustique - Appareils audiomtriques - Partie 1: Appareils pour laudiomtrie tonale (IEC 60645-1:2012) Akustik - Audiometer - Teil 1: Reinton-Audiometer (IEC 60645-1:20

6、12) 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 bibliographi

7、cal 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 responsibi

8、lity 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, Fo

9、rmer 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 Electrotechn

10、ical Standardization Comit Europen de Normalisation ElectrotechniqueEuropisches Komitee fr 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.

11、EN 60645-1:2015 E 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: latest date by which

12、the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2015-08-05 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2017-11-05 This document supersedes EN 60645-1:2001 and EN 606

13、45-4:1995. 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 El

14、ectrical 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 hav

15、e to be added for the standards indicated: IEC 61260 NOTE Harmonized as EN 61260. ISO 389-9 NOTE Harmonized as EN ISO 389-9. BS EN 60645-1:2015- 3 - EN 60645-1:2015 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following do

16、cuments, 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 Internat

17、ional 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 sys

18、tem equipment - Part 3: Amplifiers EN 60268-3 - IEC 60318-1 - Electroacoustics - Simulators of human head and ear - Part 1: Ear simulator for the measurement of supra-aural and circumaural earphones EN 60318-1 - IEC 60318-3 - Electroacoustics - Simulators of human head and ear - Part 3: Acoustic cou

19、pler for the calibration of supra-aural earphones used in audiometry EN 60318-3 - IEC 60318-4 - Electroacoustics - Simulators of human head and ear - Part 4: Occluded-ear simulator for the measurement of earphones coupled to the ear by means of ear inserts EN 60318-4 - IEC 60318-5 - Electroacoustics

20、 - Simulators of human head and ear - Part 5: 2 cm coupler for the measurement of hearing aids and earphones coupled to the ear by means of ear inserts EN 60318-5 - IEC 60318-6 - Electroacoustics - Simulators of human head and ear - Part 6: Mechanical coupler for the measurements on bone vibrators E

21、N 60318-6 - IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 60601-1 - IEC 60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagneti

22、c disturbances - Requirements and tests EN 60601-1-2 - IEC 60645-2 - Audiometers - Part 2: Equipment for speech audiometry EN 60645-2 - IEC 61672-1 - Electroacoustics - Sound level meters - Part 1: Specifications EN 61672-1 - BS EN 60645-1:2015EN 60645-1:2015 - 4 - Publication Year Title EN/HD Year

23、ISO 266 - Acoustics - Preferred frequencies EN ISO 266 - ISO 389-1 - Acoustics - Reference zero for the calibration of audiometric equipment - Part 1: Reference equivalent threshold sound pressure levels for pure tones and supra-aural earphones EN ISO 389-1 - ISO 389-2 - Acoustics - Reference zero f

24、or the calibration of audiometric equipment - Part 2: Reference equivalent threshold sound pressure levels for pure tones and insert earphones EN ISO 389-2 - ISO 389-3 - Acoustics - Reference zero for the calibration of audiometric equipment - Part 3: Reference equivalent threshold force levels for

25、pure tones and bone vibrators EN ISO 389-3 - ISO 389-4 1994 Acoustics - Reference zero for the calibration of audiometric equipment - Part 4: Reference levels for narrow-band masking noise EN ISO 389-4 1998 ISO 389-5 - Acoustics - Reference zero for the calibration of audiometric equipment - Part 5:

26、 Reference equivalent threshold sound pressure levels for pure tones in the frequency range 8 kHz to 16 kHz EN ISO 389-5 - ISO 389-7 - Acoustics - Reference zero for the calibration of audiometric equipment - Part 7: Reference threshold of hearing under free-field and diffuse-field listening conditi

27、ons EN ISO 389-7 - ISO 389-8 - Acoustics - Reference zero for the calibration of audiometric equipment - Part 8: Reference equivalent threshold sound pressure levels for pure tones and circumaural earphones EN ISO 389-8 - ISO 4869-1 - Acoustics - Hearing protectors - Part 1: Subjective method for th

28、e measurement of sound attenuation EN 24869-1 - ISO 8253-1 2010 Acoustics - Audiometric test methods - Part 1: Pure-tone air and bone conduction audiometry EN ISO 8253-1 2010 ISO 8253-2 - Acoustics - Audiometric test methods - Part 2: Sound field audiometry with pure-tone and narrow-band test signal

29、s EN ISO 8253-2 - ISO 8253-3 - Acoustics - Audiometric test methods - Part 3: Speech audiometry EN ISO 8253-3 - BS EN 60645-1:2015 2 60645-1 IEC:2012 CONTENTS INTRODUCTION . 7 1 Scope . 8 2 Normative references . 8 3 Terms and definitions . 9 4 Requirements for specific types of fixed frequency audi

30、ometer . 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 Oth

31、er 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 Int

32、erface 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 Frequen

33、cy 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 .

34、20 7 Transducers . 20 7.1 Type of transducers . 20 7.2 Headband 20 BS EN 60645-1:201560645-1 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 M

35、anual 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

36、.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 Subjects response time for automated test procedures . 24 8.6.6 Subjects response system 24 9 Reference tone . 24 9.1 General . 24 9.2 Frequencies 24 9.3 Refer

37、ence 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 condi

38、tions 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 Sig

39、nal 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 BS EN 60645-1:2015 4 60645-1 IEC:2012 13.8 Headbands 30 13.8.1 General . 30 13.8.2 Supra-aura

40、l and circumaural earphone headband 30 13.8.3 Bone vibrator headband 30 14 Maximum permitted expanded uncertainty of measurements Umax30 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 fa

41、cilities 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 ha

42、rmonic distortion, for supra-aural, circumaural, insert earphonesand 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 standar

43、ds for obtaining audiometric zero 26 Table 7 Symbols for the graphical presentation of hearing threshold levels 26 Table 8 Values of Umaxfor basic measurements 31 BS EN 60645-1:201560645-1 IEC:2012 7 INTRODUCTION Developments in the field of hearing measurements for diagnostic, hearing conservation

44、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 perf

45、ormance 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 freque

46、ncy 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 re

47、quirements 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 specifie

48、d 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 Umax compared with those of the previous edition. IEC 60645

49、 series consists of the following parts: IEC 60645-1, Electroacoustics Audiometric equipment Part 1: Equipment for pure-tone audiometry IEC 60645-2, Audiometers Part 2: Equipment for speech audiometry IEC 60645-3, Electroacoustics Audiometric equipment Part 3: Test signals of short duration IEC 60645-4, Audiometers Part 4: Equipment for extended high-frequency audiometry IEC 60645-5, Electroacoustics Audiometric equipment Part 5: Instruments for the measurement