1、 IEC 60645-6Edition 1.0 2009-04INTERNATIONAL STANDARD NORME INTERNATIONALEElectroacoustics Audiometric equipment Part 6: Instruments for the measurement of otoacoustic emissions Electroacoustique Equipements audiomtriques Partie 6: Instruments pour la mesure des missions otoacoustiques IEC60645-6:20
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16、lients ou contactez-nous: Email: csciec.ch Tl.: +41 22 919 02 11 Fax: +41 22 919 03 00 IEC 60645-6Edition 1.0 2009-04INTERNATIONAL STANDARD NORME INTERNATIONALEElectroacoustics Audiometric equipment Part 6: Instruments for the measurement of otoacoustic emissions Electroacoustique Equipements audiom
17、triques Partie 6: Instruments pour la mesure des missions otoacoustiques INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE PICS 17.140.50 PRICE CODECODE PRIXISBN 2-8318-1038-3 Registered trademark of the International Electrotechnical Commission Marque dpose de la
18、Commission Electrotechnique Internationale 2 60645-6 IEC:2009 CONTENTS FOREWORD.4 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 Stimu
19、lus types.9 5.1.3 Stimulus 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 ra
20、nge.11 5.3.3 Accuracy of 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 conform
21、ity with specifications13 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 I
22、nstruction manual.14 7.3 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 60645-6 IEC:2009 3 7.6.3 Environmental conditions.15 8 Additional c
23、haracteristics 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 4 60645-6 IEC:2009 IN
24、TERNATIONAL ELECTROTECHNICAL COMMISSION _ ELECTROACOUSTICS AUDIOMETRIC EQUIPMENT Part 6: Instruments for the measurement of otoacoustic emissions FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical c
25、ommittees (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, Techn
26、ical 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, governmen
27、tal 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 ag
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29、e 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 prom
30、ote 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 indic
31、ated in the latter. 5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in conformity with an IEC Publication. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach
32、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) a
33、nd 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.
34、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 60645-6 has been prepared by IEC technical committee 29: Electro
35、acoustics. The text of this standard is based on the following documents: FDIS Report on voting 29/673/FDIS 29/681/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 w
36、ith the ISO/IEC Directives, Part 2. 60645-6 IEC:2009 5 The list of all the parts of the IEC 60645 series, under the general title Electroacoustics Audiometric equipment, can be found on the IEC website. The committee has decided that the contents of this publication will remain unchanged until the m
37、aintenance result 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. 6 60645-6 IEC:2009 INTRODUCTION Developments in the field of di
38、agnostic 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 such instruments concerns the measurement of sound energy
39、 emitted by the inner ear and its separation from sounds emerging from other physiological or artificial sources. 60645-6 IEC:2009 7 ELECTROACOUSTICS AUDIOMETRIC EQUIPMENT Part 6: Instruments for the measurement of otoacoustic emissions 1 Scope This part of IEC 60645 applies to instruments designed
40、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 performance specifications for two types of instruments1and specifies the fu
41、nctions 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 ensure that measurements made under comparable test conditions with differe
42、nt 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 is not intended to restrict development or incorporation of new features,
43、 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 references, the latest edition of the referenced document (including any amend
44、ments) 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 of human head and ear Part 5: 2 cm3coupler for the measurement of hearing
45、 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 1-2: General requirements for basic safety and essential performance Colla
46、teral 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 60645-1:2001, Electroacoustics Audiological equipment Part 1: Pure-tone audiomet
47、ers 1Screening and full diagnostics. 2To be published. 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 measurement Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) 3 Terms an
48、d 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 can be recorded in the external acoustic meatus NOTE The spontaneous otoacoustic emissions (S
49、OAE) 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 signals emitted by the inner ear after stimulation with a stimulus of short duration 3.3 distortion product otoacoustic emissions DPOAE acoustic signals generate
