EN 60118-13-2011 en Electroacoustics - Hearing aids - Part 13 Electromagnetic compatibility (EMC)《电声学 助听器 第13部分 电磁兼容性(EMC)》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationElectroacoustics Hearing aidsPart13: Electromagnetic compatibility (EMC)BS EN 60118-13:2011National forewordThis British Standard is the UK implementation of EN 60118-13:2011. It

2、 isidentical to IEC 60118-13:2011. It supersedes BS EN 60118-13:2005 which iswithdrawn.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 publicatio

3、n does not purport to include all the necessary provisions of acontract. Users are responsible for its correct application. BSI 2011ISBN 978 0 580 58369 8ICS 17.140.50; 33.100.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under

4、the authority of the StandardsPolicy and Strategy Committee on 31 August 2011.Amendments issued since publicationAmd. No. Date Text affectedBRITISH STANDARDBS EN 60118-13:2011EUROPEAN STANDARD EN 60118-13 NORME EUROPENNE EUROPISCHE NORM August 2011 CENELEC European Committee for Electrotechnical Sta

5、ndardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Management Centre: Avenue Marnix 17, B - 1000 Brussels 2011 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60118-13:201

6、1 E ICS 17.140.50; 33.100.20 Supersedes EN 60118-13:2005English version Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC) (IEC 60118-13:2011) Electroacoustique - Appareils de correction auditive - Partie 13: Compatibilit lectromagntique (CEM) (CEI 60118-13:2011) Akustik

7、- Hrgerte - Teil 13: Elektromagnetische Vertrglichkeit (EMV) (IEC 60118-13:2011) This European Standard was approved by CENELEC on 2011-05-16. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of

8、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, French, German). A ver

9、sion 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, Belgium, Bulgaria, Croatia,

10、 Cyprus, the 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 60118-13:2011EN 60

11、118-13:2011 - 2 - Foreword The text of document 29/737/FDIS, future edition 3 of IEC 60118-13, prepared by IEC TC 29, Electroacoustics, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60118-13 on 2011-05-16. This European Standard supersedes EN 60118-13:2005. EN 6011

12、8-13:2011 introduces a new set of requirements for use of hearing aids with mobile phones. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent rights

13、. 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) 2012-02-16 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2014-05-16 This Eur

14、opean Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive MDD (93/42/EEC). See Annex ZZ. Annexes ZA and ZZ have been added by CENELEC. _ Endorsement notice The text of the Int

15、ernational Standard IEC 60118-13:2011 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: IEC 60118-4 NOTE Harmonized as EN 60118-4. _ BS EN 60118-13:2011- 3 - EN 60118-13:2

16、011 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 late

17、st 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 60118-0 - Hearing aids - Part 0: Measurement of electroaco

18、ustical characteristics EN 60118-0 - IEC 60118-2 - Hearing aids - Part 2: Hearing aids with automatic gain control circuits EN 60118-2 - IEC 60118-7 - Electroacoustics - Hearing aids - Part 7: Measurement of the performance characteristics of hearing aids for production, supply and delivery quality

19、assurance purposes EN 60118-7 - 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 inserts EN 60318-4 - IEC 60318-5 - Electroacoustics - Simulators of human head and ear - Part 5: 2 cm

20、 coupler for the measurement of hearing aids and earphones coupled to the ear by means of ear inserts EN 60318-5 - IEC 61000-4-3 - Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test EN 61000-4-3 - IEC 61

21、000-4-20 - Electromagnetic compatibility (EMC) - Part 4-20: Testing and measurement techniques - Emission and immunity testing in transverse electromagnetic (TEM) waveguides EN 61000-4-20 - BS EN 60118-13:2011EN 60118-13:2011 - 4 - Annex ZZ (informative) Coverage of Essential Requirements of EC Dire

22、ctives This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and within its scope the standard covers only the following essential requirements out of those given in Annex I of the EC Directive 93/42/EEC: ER 3, on

23、ly for the aspect of electromagnetic compatibility for performance. Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned. WARNING: Other requirements and other EC Directives may be applicable to the products falling withi

24、n the scope of this standard. BS EN 60118-13:2011 2 60118-13 IEC:2011 CONTENTS INTRODUCTION . 5 1 Scope . 7 2 Normative references . 7 3 Terms and definitions . 8 4 Requirements for immunity . 9 5 Immunity test procedures . 10 6 Measurement uncertainty . 13 Annex A (informative) Background for estab

25、lishing test methods, performance criteria and test levels 15 Bibliography 20 Figure 1 Example of a test arrangement for hearing aid immunity measurements using a one-port TEM cell (asymmetric septum) 11 Figure 2 Examples of input-output response curves at 1 000 Hz and the determination of gain at a

26、n input level of 55 dB . 12 Figure 3 Positioning of hearing aid during RF exposure . 12 Figure 4 Examples of determination of IRIL by electromagnetic immunity (EMI) testing 13 Figure A.1 Ratio of 1:2 between field strength and interference level in dB 16 Figure A.2 Example of test arrangement for he

27、aring aid immunity measurements using dipole antenna . 18 Figure A.3 Digital wireless devices antenna designs 19 Table 1 Field strengths of RF test signals to be used to establish immunity for bystander compatible and user compatible hearing aids . 9 BS EN 60118-13:201160118-13 IEC:2011 5 INTRODUCTI

28、ON This standard introduces specifications for EMC requirements for hearing aids. Hearing aids basically consist of a microphone, an amplifier, a induction pick-up coil and a small earphone (receiver). For behind the ear (BTE) hearing aids the sound is often fed to the ear canal by means of an indiv

29、idually made ear mould (ear insert). In the ear (ITE) hearing aids have the active circuitry located in the auditory canal. The power source normally used is a small battery. On some hearing aids, the user can perform some adjustments of the controls of the hearing aid, which in some cases is by mea

30、ns of a remote control. The standard only deals with hearing aid immunity, as experience has shown that hearing aids do not emit electromagnetic signals to an extent that can disturb other equipment. Other EMC phenomena, such as RF emission and electrostatic discharge, are not currently known to be

31、a significant problem in connection with hearing aids. Based on new knowledge, they could be considered in connection with future revisions or extensions of this standard. Hearing aids containing RF transmitting equipment are covered by this standard regarding immunity, however the RF transmitting e

32、quipment is not covered. Experience in connection with the use of hearing aids in recent times has identified digital wireless devices, such as DECT wireless phones and GSM mobile phones as potential sources of disturbance for hearing aids. Interference in hearing aids depends on the emitted power f

33、rom the wireless telephone as well as the immunity of the hearing aid. The performance criteria in this standard will not totally ensure hearing aid users interference- and noise-free use of wireless telephones but will establish useable conditions in most situations. In practice a hearing aid user,

34、 when using a digital wireless device, will seek, if possible, to find a position on the ear which gives a minimum or no interference in the hearing aid. Hearing aids are battery powered devices, and therefore disturbances related to a.c. or d.c. power inputs are not relevant and are therefore not c

35、onsidered in this standard. Hearing aids whose outputs are non-acoustic, e.g. cochlear implants and bone conduction hearing aids, are not covered by this standard. In some cases, hearing aids are connected to other equipment by cable, but this standard does not cover common mode transients and commo

36、n mode surges on such cable connections. Based on experience in connection with the use of hearing aids, relevant sources of disturbance for hearing aids include low frequency radiated magnetic fields, which may interact with the induction pick-up coil input included in some hearing aids. As the ind

37、uction pick-up coil input is an intended feature of some hearing aids, and the hearing aid therefore must have a certain sensitivity to low frequency magnetic fields, it is not relevant to specify immunity against disturbing low frequency magnetic fields. To avoid unintended interference from low fr

38、equency magnetic noise fields, the recommendations specified in IEC 60118-4 11, regarding specifications for induction loop systems, should be followed. With regard to high frequency radiated electromagnetic fields originating from RF wireless devices such as digital mobile telephone systems, only s

39、ources of disturbance which are currently known to be a problem in connection with hearing aids are covered. Reference is made to IEC 61000-4-3, which identifies digital radio telephone systems operating in the frequency ranges 0,8 GHz to 0,96 GHz and 1,4 GHz to 2,48 GHz to be potential sources of i

40、nterference. Future versions may add tests for other frequency bands, as they come into more common use. Hearing aids are used in all environments as outlined in IEC 61000-4-3. _ 1Figures in square brackets refer to the bibliography. BS EN 60118-13:2011 6 60118-13 IEC:2011 Various test methods have

41、been considered for determining the immunity of hearing aids. When a wireless telephone is used close to a hearing aid, there is an RF near-field illumination of the hearing aid. However, validation investigations in preparing this standard have shown that it is possible to establish a correlation b

42、etween the measured far-field immunity level and the immunity level experienced by an actual hearing aid used in conjunction with a digital wireless device. The use of a far-field test has shown high reproducibility, and is considered sufficient to verify and express the immunity of hearing aids. Ne

43、ar-field illumination of the hearing aid (i.e. by generating an RF field using a dipole antenna) could however bring valuable information during design and development of hearing aids. BS EN 60118-13:201160118-13 IEC:2011 7 ELECTROACOUSTICS HEARING AIDS Part 13: Electromagnetic compatibility (EMC) 1

44、 Scope This part of IEC 60118 in principle covers all relevant EMC phenomena for hearing aids. EMC phenomena, such as RF emission and electrostatic discharge, are not currently known to be a significant problem in connection with hearing aids and are therefore not dealt with. Based on new knowledge,

45、 they could be considered in connection with future revisions or extensions of this standard. Hearing aid immunity to high frequency electromagnetic fields originating from digital wireless devices operating in the frequency ranges 0,8 GHz to 0,96 GHz and 1,4 GHz to 2,48 GHz is currently identified

46、as the only relevant EMC phenomenon regarding hearing aids. Future editions of this part of IEC 60118 may add tests for other frequency bands, as they come into more common use. IEC 61000-4-3 is the basis for relevant EMC tests to be conducted on hearing aids. Measurement methods and acceptance leve

47、ls are described in this part of IEC 60118. For the purpose of this part of IEC 60118, two immunity classes of hearing aids are defined (see 3.1) related to their use. “Bystander compatible“ ensures that a hearing aid is usable in environments where digital wireless devices are in operation in the p

48、roximity of the hearing aid wearer. “User compatible“ hearing aids ensures that a hearing aid is usable when the wearer is using a digital wireless device at the wearers own aided ear. Measurement methods for hearing aids with non-acoustic outputs and for hearing aids connected to other equipment by

49、 cables are not given in this standard. 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 60118-0, Hearing aids Part 0: Measurement of electroacoustical characteristics IEC 60118-2, Hearing aids Part 2: Hearing aids with automatic gain control circui