1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationElectroacoustics Audiometric equipment Part 6: Instruments for the measurement of otoacoustic emissionsBS EN 60645-6:2010National forewordThis British Standard is the UK implemen
2、tation of EN 60645-6:2010. It isidentical to IEC 60645-6:2009.The UK participation in its preparation was entrusted to Technical CommitteeEPL/29, Electroacoustics.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to inc
3、lude all the necessary provisions of acontract. Users are responsible for its correct application. BSI 2010 ISBN 978 0 580 60925 1 ICS 13.140; 17.140.50Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Stan
4、dards Policy and Strategy Committee on 28 February 2010Amendments issued since publicationAmd. No. Date Text affectedBRITISH STANDARDBS EN 60645-6:2010EUROPEAN STANDARD EN 60645-6 NORME EUROPENNE EUROPISCHE NORM January 2010 CENELEC European Committee for Electrotechnical Standardization Comit Europ
5、en de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: Avenue Marnix 17, B - 1000 Brussels 2010 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60645-6:2010 E ICS 17.140.50 Engli
6、sh version Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions (IEC 60645-6:2009) Electroacoustique - Appareillage audiomtrique - Partie 6: Instruments pour la mesure des missions otoacoustiques (CEI 60645-6:2009) Akustik - Audiometer - Teil 6:
7、 Gerte zur Messung von otoakustischen Emissionen (IEC 60645-6:2009) This European Standard was approved by CENELEC on 2009-12-01. 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 st
8、andard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any o
9、ther language made by translation under the responsibility of a CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the
10、Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. BS EN 60645-6:2010EN 60645-6:2010 - 2
11、 - Foreword The text of document 29/673/FDIS, future edition 1 of IEC 60645-6, prepared by IEC TC 29, Electroacoustics, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60645-6 on 2009-12-01. The following dates were fixed: latest date by which the EN has to be implem
12、ented at national level by publication of an identical national standard or by endorsement (dop) 2010-09-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2012-12-01 Annex ZA has been added by CENELEC. _ Endorsement notice The text of the International
13、 Standard IEC 60645-6:2009 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 389-6 NOTE Harmonized as EN ISO 389-6 (not modified). _ BS EN 60645-6:2010- 3 - EN 60645-6
14、:2010 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the la
15、test edition of the referenced document (including any amendments) applies. NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. Publication Year Title EN/HD Year IEC 60318-4 - Electroacoustics - Simulators of human head an
16、d ear - Part 4: Occluded-ear simulator for the measurement of earphones coupled to the ear by means of ear inserts EN 60318-4 200X1)IEC 60318-5 - Electroacoustics - 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 o
17、f ear inserts EN 60318-5 - IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 60601-1 - IEC 60601-1-2 (mod) - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral sta
18、ndard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 - IEC 60601-1-4 - Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems EN 60601-1-4 - IEC 60645-1 2001 Electroacoustics - Audiological equipme
19、nt - Part 1: Pure-tone audiometers EN 60645-1 2001 IEC 60645-3 2007 Electroacoustics - Audiometric equipment - Part 3: Test signals of short duration EN 60645-3 2007 ISO/IEC Guide 98-3 - Uncertainty of measurement - Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) - - 1)To be
20、 published. BS EN 60645-6:2010 2 60645-6 IEC:2009 CONTENTS INTRODUCTION.6 1 Scope.7 2 Normative references .7 3 Terms and definitions .8 4 Requirements for specific instruments 9 5 General specifications 9 5.1 Acoustic stimulus system 9 5.1.1 General requirements 9 5.1.2 Stimulus types.9 5.1.3 Stimu
21、lus frequency range 10 5.1.4 Stimulus level 10 5.1.5 Harmonic distortion .11 5.2 Test quality assuring system .11 5.2.1 General .11 5.2.2 Test quality assurance.11 5.2.3 Individual stimulus recordings11 5.3 Measuring system .11 5.3.1 Units of measurement11 5.3.2 Measurement range.11 5.3.3 Accuracy o
22、f measurement .11 5.3.4 Frequency range .11 5.3.5 Noise reduction .11 5.3.6 Response detection.12 5.3.7 Quality estimates.12 5.3.8 Normative values.12 5.4 Presentation of results 12 5.4.1 General .12 5.4.2 Primary results 12 5.4.3 Secondary results13 6 Demonstration of conformity with specifications
23、13 6.1 General .13 6.2 Probe signal 13 6.2.1 Probe signal spectrum .13 6.2.2 Probe signal level and harmonic distortion.13 6.3 Maximum permitted expanded uncertainty of measurements Umax.13 6.4 Function of the complete system .14 7 General requirements.14 7.1 Marking .14 7.2 Instruction manual.14 7.
24、3 Safety requirements 14 7.4 Immunity to power and radiofrequency fields .14 7.5 Warm-up time15 7.6 Voltage supply variation and environmental conditions 15 7.6.1 Mains operation.15 7.6.2 Battery operation .15 BS EN 60645-6:201060645-6 IEC:2009 3 7.6.3 Environmental conditions.15 8 Additional charac
25、teristics to be specified by the manufacturer 15 9 Routine calibration .15 Bibliography16 Table 1 Mandatory functions for otoacoustic emission instruments 9 Table 2 Documentation of test conditions, parameters and results .12 Table 3 Values of Umaxfor basic measurements 14 BS EN 60645-6:2010 6 60645
26、-6 IEC:2009 INTRODUCTION Developments in the field of diagnostic hearing measurement have resulted in a number of instruments designed to evaluate the otoacoustic emissions of the human ear evoked by acoustic test signals having different spectral and temporal characteristics. The practical use of s
27、uch instruments concerns the measurement of sound energy emitted by the inner ear and its separation from sounds emerging from other physiological or artificial sources. BS EN 60645-6:201060645-6 IEC:2009 7 ELECTROACOUSTICS AUDIOMETRIC EQUIPMENT Part 6: Instruments for the measurement of otoacoustic
28、 emissions 1 Scope This part of IEC 60645 applies to instruments designed primarily for the measurement of otoacoustic emissions in the human external acoustic meatus evoked by acoustic probe pulses or tones. This standard defines the characteristics to be specified by the manufacturer, lays down pe
29、rformance specifications for two types of instruments1and specifies the functions to be provided on these types. This part of IEC 60645 describes methods of test to be used for approval testing and guidance on methods for undertaking routine calibration. The purpose of this part of IEC 60645 is to e
30、nsure that measurements made under comparable test conditions with different instruments complying with the standard will be consistent. Instruments which provide a measurement function not specifically within the scope of the standard shall still comply with any relevant requirements. This standard
31、 is not intended to restrict development or incorporation of new features, nor to discourage innovative approaches. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated refe
32、rences, the latest edition of the referenced document (including any amendments) applies. 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 inserts2IEC 60318-5, Electroacoustics Simulators
33、 of human head and ear Part 5: 2 cm3coupler for the measurement of hearing aids and earphones coupled to the ear by means of ear inserts IEC 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance IEC 60601-1-2, Medical electrical equipment Part
34、1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and tests IEC 60601-1-4, Medical electrical equipment Part 1-4: General requirements for safety Collateral standard: Programmable electrical medical systems IEC 60645-
35、1:2001, Electroacoustics Audiological equipment Part 1: Pure-tone audiometers 1Screening and full diagnostics. 2To be published. BS EN 60645-6:2010 8 60645-6 IEC:2009 IEC 60645-3:2007, Electroacoustics Audiometric equipment Part 3: Test signals of short duration ISO/IEC Guide 98-3, Uncertainty of me
36、asurement Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 otoacoustic emissions OAE general term covering all types of acoustic signals generated in the inner ear which
37、can be recorded in the external acoustic meatus NOTE The spontaneous otoacoustic emissions (SOAE) and stimulus frequency otoacoustic emissions (SFOAE) which are also a part of the otoacoustic emissions are not be covered by this standard. 3.2 transient-evoked otoacoustic emissions TEOAE acoustic sig
38、nals emitted by the inner ear after stimulation with a stimulus of short duration 3.3 distortion product otoacoustic emissions DPOAE acoustic signals generated in the inner ear during stimulation with two pure tones (frequencies f1and f2, f1being the lower frequency) NOTE The frequencies of the DPOA
39、E are given by the formulas for distortions 3f1, 2f1-f2, 2f2-f1, 3f2, etc. 3.4 nominal test frequency the frequency for which a DPOAE measurement is reported 3.5 primary tones pure tone stimuli used to evoke DPOAEs 3.6 probe part of the instrument, usually containing transducers, interfacing the ins
40、trument to the ear 3.7 ear tip device used to provide a seal between the probe and the external acoustic meatus 3.8 probe signal acoustic signal that is emitted into the external auditory meatus by means of a probe 3.9 peak-to-peak equivalent sound pressure level peSPL r.m.s. value of a long-duratio
41、n sinusoidal sound signal which, when compared under the same test conditions with a short-duration output signal from the transducer under test, has the BS EN 60645-6:201060645-6 IEC:2009 9 same peak-to-peak value (i.e., difference between the extreme positive and the extreme negative values) as th
42、e short-duration signal NOTE See IEC 60645-3:2007, Figure 2. 4 Requirements for specific instruments Two different types of otoacoustic emission instrument are specified by the requirements for minimum mandatory functions (see Table 1). Additional functions are not precluded. The two types relate to
43、 their presumed primary application (screening and diagnostic/clinical). Instrument types 1 Diagnostic/clinical: Adjustable stimulus and recording parameters, result shown in a graphical format 2 Screening: Automatic testing, automatic evaluation, results as pass/refer Table 1 Mandatory functions fo
44、r otoacoustic emission instruments Type 1 Diagnostic/clinical 2 Screening Automatic test x x Manual test x Presentation of results Display of full result x Display of PASS/REFER x Display of a quality measure estimate x Display of response significance x Digital storage of full result x Printout x 5
45、 General specifications 5.1 Acoustic stimulus system 5.1.1 General requirements Specifications for the acoustic stimulus system are as given in the relevant parts of Clauses 6, 8 and 10 of IEC 60645-1:2001 and Clause 5 of IEC 60645-3:2007 with the exceptions specified below. NOTE If the instrument i
46、s designed to allow also the measurement of hearing thresholds, the full text of IEC 60645-1:2001 should apply. 5.1.2 Stimulus types 5.1.2.1 General The general properties and temporal characteristics of the acoustic stimulus signals are specified within the following sections depending on the type
47、of OAEs. BS EN 60645-6:2010 10 60645-6 IEC:2009 5.1.2.2 TEOAE The full characteristics of the short-duration signal used for the measurements of TEOAEs shall be specified by the manufacturer (i.e., as specified in IEC 60645-3:2007). NOTE Series of clicks with different polarity and levels are often
48、used, usually referred to as non-linear click series. The specifications found in IEC 60645-3 are applicable to each single click in the series. 5.1.2.3 DPOAE The stimulus signal used for the measurement of DPOAEs shall be composed of two primary tones, f1and f2. The nominal test frequency normally
49、refers to f1. If f2is used as the nominal test frequency, this shall be stated by the manufacturer. If additional test signals are used, their full characteristics shall be specified by the manufacturer. 5.1.3 Stimulus frequency range 5.1.3.1 General The frequency of the stimulus signals shall meet at least the requirements specified in the following subclauses depending on the type of OAEs. 5.1.3.2 TEOAE The stimulus shall cover the range from 0,5
