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1、BRITISH STANDARD BS EN 61669:2001 IEC 61669:2001 Electroacoustics Equipment for the measurement of real-ear acoustical characteristics of hearing aids The European Standard EN 61669:2001 has the status of a British Standard ICS 17.140.50 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYR
2、IGHT LAW Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 04:27:00 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 61669:2001 This British Standard, having been prepared under the direction of the Electrotechnical Sector Committee, was published under the authority of the Standards Committee
3、and comes into effect on 15 August 2001 BSI 08-2001 ISBN 0 580 38086 6 National foreword This British Standard is the official English language version of EN 61669:2001. It is identical with IEC 61669:2001. The UK participation in its preparation was entrusted to Technical Committee EPL/29, Electroa
4、coustics, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. From 1 January 1997, all IEC publications have the number 60000 added to the old number. For instance, IEC 27-1 has been renumbered as IEC 60027-1. For a peri
5、od of time during the change over from one numbering system to the other, publications may contain identifiers from both systems. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue und
6、er the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct a
7、pplication. 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 committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed
8、; 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, pages 2 to 19 and a back cover. The BSI copyright date displayed in this document indicates when the document was
9、 last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 04:27:00 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARDEN 61669 NORME EUROPENNE EUROPISCHE NORMMay 2001 CENELEC European Committee for Electrotechnical Standar
10、dization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2001 CENELEC -All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 61669:2001 E
11、ICS 17.140.50 English version Electroacoustics - Equipment for the measurement of real-ear acoustical characteristics of hearing aids (IEC 61669:2001) Electroacoustique - Appareillage pour la mesure des caractristiques acoustiques des appareils de correction auditive sur loreille relle (CEI 61669:20
12、01) Elektroakustik - Gerte zur Messung der Kenndaten von Hrgerten am menschlichen Ohr (IEC 61669:2001) This European Standard was approved by CENELEC on 2001-03-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European S
13、tandard 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 Secretariat or to any CENELEC member. This European Standard exists in three official versions (English,
14、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 the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgi
15、um, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 04:27:00 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 61669:2001-
16、2 - Foreword The text of document 29/476/FDIS, future edition 1 of IEC 61669, prepared by IEC TC 29, Electroacoustics, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 61669 on 2001-03-01. The following dates were fixed: latest date by which the EN has to be implement
17、ed at national level by publication of an identical national standard or by endorsement(dop) 2001-12-01 latest date by which the national standards conflicting with the EN have to be withdrawn(dow) 2004-03-01 Annexes designated “normative“ are part of the body of the standard. In this standard, anne
18、x ZA is normative. Annex ZA has been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 61669:2001 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 standards
19、 indicated: IEC 60118-0 NOTE: Harmonized as HD 450.0 S1:1984 (not modified). IEC 60118-7NOTE: Harmonized as EN 60118-7:1993 (not modified). _ Page 2 EN 61669:2001 BSI 082001 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 04:27:00 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 61669 IEC:2001 3 CO
20、NTENTS Page INTRODUCTION 5 Clause 1Scope 6 2Normative references. 6 3Terms and definitions 6 4Limitations 10 5General requirements .11 5.1General .11 5.2Safety requirements.11 5.3Warm-up time11 5.4Environmental conditions.11 5.5Power supply variation.11 5.6Immunity to power and radio frequency field
21、s 12 5.7Interface connections.12 6Test signal characteristics 12 6.1Test signal.12 6.2Sound source 12 6.3Test signal level.12 6.4Test signal level indication.12 6.5Equalization.12 6.6Frequency .13 6.7Harmonic distortion13 6.8Equipment for automatic sweep frequency recording .13 6.9Integrity of test
22、signal 13 7Sound measurement.13 7.1Probe microphone measurement .13 7.2Noise floor of probe microphone measurement 13 7.3Attenuation of probe microphone to external signals13 8Data acquisition, analysis and presentation 14 8.1General .14 8.2Output indication .14 8.3Graphical printout 14 9Calibration
23、 14 10Demonstration of conformity with specifications and test procedures 14 10.1 General .14 10.2 Environmental conditions and power supply variation 15 10.3 Immunity to power and radio frequency fields 15 10.4 Test signals .15 10.4.1 Signal accuracy .15 10.4.2 Accuracy of control 15 Page 3 EN 6166
24、9:2001 BSI 082001 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 04:27:00 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 61669 IEC:2001 4 ClausePage 10.5 Sound measurement16 10.5.1 Measurement accuracy16 10.5.2 Noise floor of probe microphone measurement 16 10.5.3 Attenuation of probe microphone
25、 to external signals 16 11Maximum permitted expanded uncertainty of measurements.16 12Marking and instruction manual 17 12.1 Marking .17 12.2 Software version17 12.3 Instruction manual .17 Bibliography18 Annex ZA (normative) Normative references to international publications with their corresponding
26、 European publications .19 Page 4 EN 61669:2001 BSI 082001 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 04:27:00 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 61669 IEC:2001 5 INTRODUCTION The performance characteristics of hearing aids in actual use can differ significantly from those determ
27、ined in accordance with standards such as IEC 60118-0, and IEC 60118-7, due to differing acoustic influence and coupling presented by individual ears. Measuring methods that take into account the acoustic coupling and the acoustic influence of the individual wearer on the performance of hearing aids
28、 are therefore important in the fitting of these devices. Such measuring methods have come to be known as “real-ear measurements” and are sometimes performed clinically in less than ideal acoustic environments. The accuracy and repeatability of measurements made under such conditions are complex fun
29、ctions of the sound field, the test environment, the nature of the test signal, the hearing aid under evaluation, the method of test signal control, the location of the sound source, the nature of the data acquisition, analysis and presentation as well as the degree of subject movement permitted. Th
30、is International Standard specifies performance requirements separate from the test requirements to show conformity. Conformance to the specifications in this International Standard is demonstrated only when the result of a measurement, extended by the actual expanded uncertainty of measurement of t
31、he testing laboratory, lies fully within the tolerances specified in this International Standard extended by the values for Umax given in table 1. Page 5 EN 61669:2001 BSI 082001 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 04:27:00 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 61669 IEC:2001
32、 6 ELECTROACOUSTICS EQUIPMENT FOR THE MEASUREMENT OF REAL-EAR ACOUSTICAL CHARACTERISTICS OF HEARING AIDS 1 Scope This International Standard specifies the general requirements for test equipment designed for use in measuring the real-ear acoustical characteristics of hearing aids and describes the t
33、erminology used. The purpose of this International Standard is to ensure that measurements of real-ear acoustical characteristics of a hearing aid on a given human ear, performed with different test equipment which comply with this International Standard using methods described in ISO 12124, shall g
34、ive substantially the same results. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do n
35、ot apply. However, parties to agreements based on this part of the ISO/IEC Directives are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applie
36、s. Members of ISO and IEC maintain registers of currently valid International Standards. IEC 60601-1, Medical electrical equipment Part 1: General requirements for safety IEC 60601-1-2, Medical electrical equipment Part 1: General requirements for safety 2. Collateral standard: Electromagnetic compa
37、tibility Requirements and tests IEC 60601-1-4, Medical electrical equipment Part 1: General requirements for safety 4. Collateral standard: Programmable electrical medical systems IEC 60645-1, Audiometers Part 1: Pure tone audiometers IEC 60942, Electroacoustics Sound calibrators ISO 266, Acoustics
38、Preferred frequencies 3 Terms and definitions For the purpose of this International Standard, the following terms and definitions apply: 3.1 test signal acoustic signal at the field reference point Page 6 EN 61669:2001 BSI 082001 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 04:27:00 GMT+00
39、:00 2006, Uncontrolled Copy, (c) BSI 61669 IEC:2001 7 3.2 subject person in whose ear the hearing aid performance is characterized 3.3 subject reference point point bisecting the line joining the centres of the openings of the ear canals of the subject (at the junction between concha and ear canal)
40、NOTE In cases of severe head shape abnormality or asymmetry, it may not be easy to determine the reference point of the subject. The subject reference point used should then be stated. 3.4 test axis line joining the subject reference point to the sound source passing along the axis of the sound sour
41、ce 3.5 working distance distance from the subject reference point to the plane of the mounting ring or protective grille of the sound source measured along the test axis 3.6 sound pressure level (SPL) twenty times the logarithm to the base 10 of the ratio of a given root-mean-square sound pressure t
42、o the reference sound pressure (IEV 801-22-07, modified) NOTE Throughout this International Standard all sound pressure levels refer to 20 Pa. 3.7 band sound pressure level sound pressure level measurement for a defined band 3.8 test signal level level of the test signal expressed as a sound pressur
43、e level in decibels (dB) NOTE For broad-band signals, the frequency spectrum should be specified and stated. 3.9 equalization process of controlling the test signal level as a function of frequency such that it does not vary from the desired level 3.10 reference microphone controlling microphone mic
44、rophone used to measure the test signal level in the measurement process and/or to control it in the equalization process 3.11 sound inlet aperture through which sound enters a microphone and at which the microphone is calibrated NOTE In the case of a probe microphone (see 3.13) which includes an ex
45、tension tube, this will be the open end of the probe tube. Page 7 EN 61669:2001 BSI 082001 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 04:27:00 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 61669 IEC:2001 8 3.12 field reference point point at which the sound inlet of the reference microphone
46、 is located during equalization and/or measurement 3.13 probe microphone microphone adapted to determine the sound pressure level in the ear canal NOTE The probe microphone may include an extension tube. 3.14 test ear ear of the subject in which the sound inlet of the probe microphone is placed 3.15
47、 measurement point point in the ear canal of the test ear at which the sound inlet of the probe microphone is placed 3.16 test signal type identification of the test signal in terms of its frequency spectrum and/or temporal properties 3.17 concurrent equalization real time equalization equalization
48、performed at the time of measurement based on the monitoring of the test signal level 3.18 stored equalization equalization performed at the time of measurement based on data recorded during a prior measurement of the sound field 3.19 substitution method method of measurement using stored equalizati
49、on with the reference microphone located at the subject reference point and the subject absent during the recording of the sound field data 3.20 modified pressure method method of measurement using stored or concurrent equalization with the field reference point near the surface of the head close to the test ear, but outside the acoustic influence of the pinna and the hearing aid NOTE The exact location of the field reference point should be specified by its perpendicular distance from