1、 IEC 60645-7Edition 1.0 2009-04INTERNATIONAL STANDARD NORME INTERNATIONALEElectroacoustics Audiometric equipment Part 7: Instruments for the measurement of auditory brainstem responses Electroacoustique Equipements audiomtriques Partie 7: Instruments pour la mesure des rponses du tronc crbral une st
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16、ons, visitez le FAQ du Service clients ou contactez-nous: Email: csciec.ch Tl.: +41 22 919 02 11 Fax: +41 22 919 03 00 IEC 60645-7Edition 1.0 2009-04INTERNATIONAL STANDARD NORME INTERNATIONALEElectroacoustics Audiometric equipment Part 7: Instruments for the measurement of auditory brainstem respons
17、es Electroacoustique Equipements audiomtriques Partie 7: Instruments pour la mesure des rponses du tronc crbral une stimulation auditive INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE MICS 17.140.50 PRICE CODECODE PRIXISBN 2-8318-1038-4 Registered trademark of t
18、he International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale 2 60645-7 IEC:2009 CONTENTS FOREWORD.3 INTRODUCTION.5 1 Scope.6 2 Normative references .6 3 Terms and definitions .6 4 Requirements for specific instruments 7 5 General specifications 8 5.1 Mea
19、suring system .8 5.1.1 Units of measurement8 5.1.2 Measurement range.8 5.1.3 Time resolution8 5.2 Stimulus system 8 5.2.1 General requirements 8 5.2.2 Stimulus types.8 5.3 Test quality assuring system .8 5.3.1 Recording conditions .8 5.3.2 Response detection.9 5.3.3 Quality estimates.9 5.3.4 Referen
20、ce values.9 5.4 Presentation of results 9 6 Demonstration of conformity with specifications9 6.1 General .9 6.2 Signal-to-noise ratio improvement .9 6.3 Maximum permitted expanded uncertainty of measurements Umax.9 7 General requirements.10 7.1 Marking .10 7.2 Instruction manual.10 7.3 Safety requir
21、ements 10 7.3.1 General .10 7.3.2 Immunity to power and radiofrequency fields .10 7.4 Warm-up time10 7.5 Voltage supply variation and environmental conditions 11 7.5.1 Mains operation.11 7.5.2 Battery operation .11 7.5.3 Environmental conditions.11 8 Routine calibration .11 Bibliography12 Table 1 In
22、strumentation requirements 7 Table 2 Documentation of test conditions, parameters and results .9 Table 3 Values of Umaxfor basic measurements 10 60645-7 IEC:2009 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ ELECTROACOUSTICS AUDIOMETRIC EQUIPMENT Part 7: Instruments for the measurement of auditory b
23、rainstem responses FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning sta
24、ndardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their prepara
25、tion is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely wit
26、h the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subj
27、ects since each technical committee has representation from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical
28、 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 promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent p
29、ossible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any eq
30、uipment 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 to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and
31、 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) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications. 8) At
32、tention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights.
33、 IEC shall not be held responsible for identifying any or all such patent rights. International Standard IEC 60645-7 has been prepared by IEC technical committee 29: Electroacoustics. The text of this standard is based on the following documents: FDIS Report on voting 29/674/FDIS 29/682/RVD Full inf
34、ormation 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 with the ISO/IEC Directives, Part 2. 4 60645-7 IEC:2009 The list of all the parts of the IEC 60645 series, under the general tit
35、le 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 maintenance result date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publicat
36、ion. At this date, the publication will be reconfirmed; withdrawn; replaced by a revised edition, or amended. 60645-7 IEC:2009 5 INTRODUCTION Developments in the field of diagnostic hearing measurement have resulted in a number of instruments designed to evaluate the auditory evoked potentials of th
37、e human hearing system which can be evoked by acoustic or vibratory signals having different spectral and temporal characteristics. The practical use of such instruments concerns the measurement of these electric potentials and their separation from electric signals emerging from other physiological
38、 or artificial sources. 6 60645-7 IEC:2009 ELECTROACOUSTICS AUDIOMETRIC EQUIPMENT Part 7: Instruments for the measurement of auditory brainstem responses 1 Scope This part of IEC 60645 applies to instruments designed for the measurement of auditory evoked potentials from the inner ear, the auditory
39、nerve and the brainstem, evoked by acoustic and/or vibratory stimuli of short duration. This part of IEC 60645 defines the characteristics to be specified by the manufacturer, specifies performance requirements for two types of instrument, screening and diagnostic, and specifies the functions to be
40、provided on these types. The purpose of this part of IEC 60645 is to ensure that measurements made under comparable test conditions with different instruments complying with this standard will be consistent. This part of IEC 60645 is not intended to restrict development or incorporation of new featu
41、res, nor to discourage innovative approaches. The application of electric stimuli for special purposes is beyond the scope of this standard. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited
42、applies. For undated references, the latest edition of the referenced document (including any amendments) applies. IEC 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance IEC 60645-1:2001, Electroacoustics Audiological equipment Part 1: Pure-
43、tone audiometers IEC 60645-3:2007, Electroacoustics Audiometric equipment Part 3: Test signals of short duration ISO 389 (all parts), Acoustics Reference zero for the calibration of audiometric equipment ISO/IEC Guide 98-3, Uncertainty of measurement Part 3: Guide to the expression of uncertainty in
44、 measurement (GUM:1995) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 auditory evoked potentials AEP electric potentials which can be evoked by acoustic or vibratory stimulation of the auditory system and recorded by means of electrodes 606
45、45-7 IEC:2009 7 3.2 electric response audiometry ERA method for recording the AEPs 3.3 auditory brainstem response ABR transient AEPs generated in the inner ear, the auditory nerve and the brainstem after stimulation of the ear with an acoustic or vibratory force stimulus of short duration NOTE A me
46、thod for recording the ABRs is also known as BERA (brainstem electric response audiometry). 3.4 automated auditory brainstem response AABR automatic detection of auditory brainstem responses 4 Requirements for specific instruments Two different types of ERA instrument are specified by the requiremen
47、ts for minimum mandatory functions (see Table 1). Other functions are not precluded. The two types relate to their presumed primary application (diagnostic/clinical and screening). Table 1 Instrumentation requirements TypeFeature 1 Diagnostic/clinical 2 Screening Stimulus Stimulus according to IEC 6
48、0645-3 x x1Adjustable stimulus level, level control x Contra-lateral masking facility x2Signal processing Artefact rejection x x User adjustable averaging x Automatic response detection x Presentation of results Display of result x Display of PASS/REFER x Display of a quality measure x Documentation
49、 Display, internal/external storage, and export of test results/parameters x 1 If a different test signal is used, it shall be described by the manufacturer. 2 Usually a white noise signal is used for contra-lateral masking. 8 60645-7 IEC:2009 5 General specifications 5.1 Measuring system 5.1.1 Units of measurement SI units or derived SI units shall be used. The units of me
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