1、BRITISH STANDARD BS EN 60645-5:2005 Electroacoustics Audiometric equipment Part 5: Instruments for the measurement of aural acoustic impedance/admittance The European Standard EN 60645-5:2005 has the status of a British Standard ICS 17.140.50 BS EN 60645-5:2005 This British Standard was published un
2、der the authority of the Standards Policy and Strategy Committee on 9 March 2005 BSI 9 March 2005 ISBN 0 580 45430 4 National foreword This British Standard is the official English language version of EN 60645-5:2005. It is identical with IEC 60645-5:2004. It supersedes BS EN 61027:1993, which is wi
3、thdrawn. The UK participation in its preparation was entrusted to Technical Committee EPL/29, Electro-acoustics, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement
4、international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not
5、 purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European com
6、mittee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, the forewo
7、rd page, pages 3 to 29 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEAN STANDARD EN 60645-5 NORME EUROPENNE EUROPISCHE NORM January 2005 CENELEC European Committee for
8、 Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2005 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
9、 Ref. No. EN 60645-5:2005 E ICS 17.140.50 Supersedes EN 61027:1993English version Electroacoustics Audiometric equipment Part 5: Instruments for the measurement of aural acoustic impedance/admittance (IEC 60645-5:2004) Electroacoustique Appareillage audiomtrique Partie 5: Instruments pour la mesure
10、de limpdance ou de ladmittance aurale (impdancemtres ou admittancemtres) (CEI 60645-5:2004) Akustik Audiometer Teil 5: Gerte zur Messung der akustischen Impedanzen/Admittanzen des Gehrs (IEC 60645-5:2004) This European Standard was approved by CENELEC on 2004-12-01. CENELEC members are bound to comp
11、ly 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 bibliographical references concerning such national standards may be obtained on application to the Central Sec
12、retariat 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 responsibility of a CENELEC member into its own language and notified to the Central Secretariat has the same status as
13、 the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovaki
14、a, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Foreword The text of document 29/563/FDIS, future edition 1 of IEC 60645-5, prepared by IEC TC 29, Electroacoustics, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60645-5 on 2004-12-01. This European Stand
15、ard supersedes EN 61027:1993. The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2005-09-01 latest date by which the national standards conflicting with the EN have to be withdra
16、wn (dow) 2007-12-01 Annex ZA has been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 60645-5:2004 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the standa
17、rds indicated: ISO 389-1 NOTE Harmonized as EN ISO 389-1:2000 (not modified). ISO 389-2 NOTE Harmonized as EN ISO 389-2:1996 (not modified). _ Page2 EN606455:2005 CONTENTS INTRODUCTION.4 1 Scope.5 2 Normative references .5 3 Terms and definitions .6 4 Requirements for specific instruments 9 5 Genera
18、l specifications 10 6 Demonstration of conformity with specifications14 7 Calibration cavities .17 8 General requirements.17 9 Symbols, forms and formats for acoustic impedance/admittance data.19 10 Additional characteristics to be specified by the manufacturer 20 Annex A (informative) Routine calib
19、ration.23 Annex B (informative) Units and terms.24 Annex C (informative) Overall temporal characteristics 26 Annex ZA (normative) Normative references to international publications with their corresponding European publications .28 Bibliography29 Page3 EN606455:2005 INTRODUCTION Developments in the
20、field of diagnostic hearing measurement have resulted in a number of instruments designed to evaluate the acoustic impedance/admittance of the human ear by means of acoustic probe signals having different frequencies and temporal characteristics. The practical use of such instruments concerns to a l
21、arge extent the measurement of changes in acoustic impedance/admittance caused either by varying the air pressure in the external acoustic meatus or by activating the middle ear muscle reflex. Page4 EN606455:2005ELECTROACOUSTICS AUDIOMETRIC EQUIPMENT Part 5: Instruments for the measurement of aural
22、acoustic impedance/admittance 1 Scope This part of IEC 60645 applies to instruments designed primarily for the measurement of acoustic impedance/admittance in the human external acoustic meatus using a stated probe tone. It is recognized that other probe signals may also be used. The standard define
23、s the characteristics to be specified by the manufacturer, lays down performance specifications for three types of instruments and specifies the facilities to be provided on these types. This standard describes methods of test to be used for approval testing and guidance on methods for undertaking r
24、outine calibration. The purpose of this standard is to ensure that measurements made under comparable test conditions with different instruments complying with the standard will be consistent. The standard is not intended to restrict development or incorporation of new features, nor to discourage in
25、novative 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 amendments) applies. IEC 6
26、0126, IEC reference coupler for the measurement of hearing aids using earphones coupled to the ear by means of ear inserts 1IEC 60601-1, Medical electrical equipment Part 1: General requirements for safety IEC 60601-1-2, Medical electrical equipment Part 1-2: General requirements for safety Collater
27、al standard: Electromagnetic compatibility Requirements and tests IEC 60601-1-4, Medical electrical equipment Part 1: General requirements for safety Collateral standard: Programmable electrical medical systems IEC 60645-1:2001, Electroacoustics Audiological equipment Part 1: Pure-tone audio- meters
28、 BIPM/IEC/IFCC/ISO/IUPAC/IUPAP/OIML, Guide to the expression of uncertainty in measurement (GUM) _ 1To be revised as IEC 60318-5. Page5 EN606455:20053 Terms and definitions For the purposes of this document the following terms and definitions apply. NOTE The units in this standard conform to the Int
29、ernational System of Units (SI). However, for audiological measurements test results have traditionally often been reported in other units. To provide information on the conversion from such units to SI units, Annex B has been compiled. 3.1 aural impedance/admittance general term covering all aspect
30、s of acoustic impedance/admittance of the ear NOTE Throughout this standard the term aural impedance/admittance will be employed as a general term covering all aspects of acoustic impedance/admittance of the ear, except where reference is made to specific derivatives. 3.2 acoustic impedance at a spe
31、cified surface, quotient of sound pressure by volume velocity through the surface NOTE 1 The symbol is Z aand the unit is the pascal second per metre to the third power (Pa s/m 3 ) NOTE 2 The quantity usually measured is the modulus. 3.3 acoustic resistance real component of complex acoustic impedan
32、ce NOTE The symbol is R aand the unit is the pascal second per metre to the third power (Pa s/m 3 ). 3.4 acoustic reactance imaginary component of complex acoustic impedance NOTE The symbol is X aand the unit is the pascal second per metre to the third power (Pa s/m 3 ). 3.5 acoustic admittance at a
33、 given surface, the reciprocal of acoustic impedance at the same surface NOTE 1 The symbol is Y aand the unit is the metre to the third power per pascal second (m 3 /Pa s). NOTE 2 Thus, the acoustic admittance at a given surface is the complex ratio of the volume velocity through the surface of the
34、sound pressure averaged over the surface. The quantity usually measured is the modulus. 3.6 acoustic conductance real component of complex acoustic admittance NOTE The symbol is G aand the unit is the metre to the third power per pascal second (m 3 /Pa s). 3.7 acoustic susceptance imaginary componen
35、t of complex acoustic admittance NOTE The symbol is B aand the unit is the metre to the third power per pascal second (m 3 /Pa s). 3.8 acoustic inertance ratio of the driving sound pressure to the resulting rate of change in volume velocity NOTE The symbol is M aand the unit is the pascal second to
36、the second power per metre to the third power (Pa s 2 /m 3 ). Page6 EN606455:20053.9 acoustic compliance ratio of volume displacement to sound pressure NOTE The symbol is C aand the unit is the metre to third power per pascal (m 3 /Pa). 3.10 equivalent volume volume of an air-filled hard-walled cyli
37、ndrical cavity that offers the equivalent acoustic impedance/admittance NOTE 1 The volume is given by the formula: a 2 a s e C c C p V = = where V eis the equivalent volume in m 3 ; is the ratio of specific heat for air at constant pressure to that at constant volume (approximately 1,40); p sis the
38、barometric air pressure in Pa; is the ambient density of air in kg/m 3 , at the temperature and pressure of the measurement; c is the speed of sound in m/s at the temperature and pressure of the measurement; C ais the acoustic compliance in m 3 /Pa. NOTE 2 It has been practice to refer to aural impe
39、dance/admittance at the probe tone frequency of 226 Hz as an equivalent volume of air. NOTE 3 For a probe tone frequency of 226 Hz, the equivalent volume of air is equal to its physical volume provided the latter does not exceed 5 cm 3 . 3.11 relative pressure in the external acoustic meatus differe
40、nce between the pressure in the external acoustic meatus and the ambient barometric pressure in daPa 3.12 probe coupling device that is inserted into the external acoustic meatus to connect the instrument to the ear 3.13 ear tip device used to provide a seal between the probe and the external acoust
41、ic meatus 3.14 probe signal acoustic signal that is emitted into the external auditory meatus by means of a probe NOTE The signal is used to measure acoustic impedance/admittance. 3.15 probe ear ear into which the probe in inserted 3.16 measurement plane plane located at the frontal surface of the p
42、robe perpendicular to the volume velocity vector Page7 EN606455:20053.17 tympanometry measurement of change of aural impedance/admittance as a function of air pressure in the external acoustic meatus NOTE The measured acoustic impedance/admittance values may depend on rate and direction of change of
43、 air pressure as well as time spent with a certain constant air pressure in the external acoustic meatus. 3.17.1 measurement plane tympanometry measurement of change of the aural impedance/admittance at the measurement plane, comprising the combined impedance/admittance of the middle ear and part of
44、 the external acoustic meatus 3.17.2 meatus-compensated tympanometry measurement of the vector difference between the aural impedance/admittance obtained at the test pressure and that obtained at a specific reference pressure in the external acoustic meatus for a given fitting of the probe NOTE 1 Th
45、e reference pressure should be such as to effectively eliminate the influence of the middle ear. NOTE 2 The reference pressure will normally be 200 daPa different from the indicated pressure, which gives maximum admittance or minimum impedance indication, or fixed at 200 daPa relative to ambient pre
46、ssure. 3.18 tympanogram graphical display of some quantity related to aural impedance/admittance as a function of air pressure in the external acoustic meatus 3.19 middle-ear muscle reflex change in tonus of muscles of the middle ear in response to stimulation NOTE The change may be measured as a va
47、riation in the acoustic impedance/admittance within the external auditory meatus 3.19.1 acoustic reflex middle-ear muscle reflex elicited by an acoustic stimulus 3.19.2 non-acoustic reflex middle-ear muscle reflex elicited by a non-acoustic stimulus 3.20 acoustic reflex activating stimulus acoustic
48、stimulus that is used to elicit an acoustic reflex 3.21 stimulus ear ear to which a reflex activating stimulus is presented in order to elicit a middle ear muscle reflex 3.22 ipsilateral reflex middle ear muscle reflex elicited in the stimulus ear Page8 EN606455:20053.23 contralateral reflex middle
49、ear muscle reflex elicited in the ear contralateral to the stimulus ear 4 Requirements for specific instruments Three different types of aural acoustic impedance/admittance instruments are specified by the requirements for minimum mandatory facilities (see Table 1). Other facilities are not precluded. The three types relate to their presumed primary application. Table 1 M
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