BS ISO 14117-2013 Active implantable medical devices Electromagnetic compatibility EMC test protocols for implantable cardiac pacemakers implantable cardioverter defibrillators and.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationActive implantable medicaldevices Electromagnetic compatibility EMC test protocols for implantable cardiac pacemakers, implantablecardioverter defibrillators and cardiac resynchr

2、onization devicesBS ISO 14117:2012National forewordThis British Standard is the UK implementation of ISO 14117:2012.The UK participation in its preparation was entrusted by Technical CommitteeCH/150, Implants for surgery, to Subcommittee CH/150/2, Cardiovascularimplants.A list of organizations repre

3、sented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions of acontract. Users are responsible for its correct application. The British Standards Institution 2013Published by BSI Standards Limited 2013ISBN 978 0 580 6

4、8877 5ICS 11.040.40; 33.100.01Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of the StandardsPolicy and Strategy Committee on 31 March 2013.Amendments issued since publicationAmd. No. Date Text affectedBRITISH S

5、TANDARDBS ISO 14117:2012 ISO 2012Active implantable medical devices Electromagnetic compatibility EMC test protocols for implantable cardiac pacemakers, implantable g70g68g85g71g76g82g89g72g85g87g72g85g3g71g72g191g69g85g76g79g79g68g87g82g85g86g3g68g81g71g3g70g68g85g71g76g68g70g3resynchronization dev

6、icesDispositifs mdicaux implantables actifs Compatibilit lectromagntique Protocoles dessai EMC pour pacemakers g70g68g85g71g76g68g84g88g72g86g3g76g80g83g79g68g81g87g68g69g79g72g86g15g3g71g112g191g69g85g76g79g79g68g87g72g88g85g86g3g76g80g83g79g68g81g87g68g69g79g72g86g3g72g87g3g71g76g86g83g82g86g76g87

7、g76g73g86g3g71g72g3resynchronisation cardiaqueINTERNATIONAL STANDARDISO14117First edition2012-07-15Reference numberISO 14117:2012(E)BS ISO 14117:2012ISO 14117:2012(E)ii ISO 2012 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2012g36g79g79g3g85g76g74g75g87g86g3g85g72g86g72g85g89g72g71g17g3g56g81

8、g79g72g86g86g3g82g87g75g72g85g90g76g86g72g3g86g83g72g70g76g191g72g71g15g3g81g82g3g83g68g85g87g3g82g73g3g87g75g76g86g3g83g88g69g79g76g70g68g87g76g82g81g3g80g68g92g3g69g72g3g85g72g83g85g82g71g88g70g72g71g3g82g85g3g88g87g76g79g76g93g72g71g3g76g81g3g68g81g92g3g73g82g85g80g3g82g85g3g69g92g3g68g81g92g3g80

9、g72g68g81g86g15g3g72g79g72g70g87g85g82g81g76g70g3g82g85g3g80g72g70g75g68g81g76g70g68g79g15g3g76g81g70g79g88g71g76g81g74g3g83g75g82g87g82g70g82g83g92g76g81g74g3g68g81g71g3g80g76g70g85g82g191g79g80g15g3g90g76g87g75g82g88g87g3g83g72g85g80g76g86g86g76g82g81g3g76g81g3g90g85g76g87g76g81g74g3g73g85g82g80g3

10、g72g76g87g75g72g85g3g44g54g50g3g68g87g3g87g75g72g3g68g71g71g85g72g86g86g3g69g72g79g82g90g3g82g85g3g44g54g50g182g86g3g80g72g80g69g72g85g3g69g82g71g92g3g76g81g3g87g75g72g3g70g82g88g81g87g85g92g3g82g73g3g87g75g72g3g85g72g84g88g72g86g87g72g85g17g44g54g50g3g70g82g83g92g85g76g74g75g87g3g82g73g191g70g72g38

11、g68g86g72g3g83g82g86g87g68g79g72g3g24g25g3g135g3g38g43g16g20g21g20g20g3g42g72g81g72g89g68g3g21g19Tel. + 41 22 749 01 11g41g68g91g3g14g3g23g20g3g21g21g3g26g23g28g3g19g28g3g23g26g40g16g80g68g76g79g3g70g82g83g92g85g76g74g75g87g35g76g86g82g17g82g85g74Web www.iso.orgg51g88g69g79g76g86g75g72g71g3g76g81g3g

12、54g90g76g87g93g72g85g79g68g81g71BS ISO 14117:2012ISO 14117:2012(E) ISO 2012 All rights reserved iiiContents g51g68g74g72Foreword ivIntroduction v1 Scope 12 Normative references . 1g22g3 g55g72g85g80g86g3g68g81g71g3g71g72g191g81g76g87g76g82g81g86g15g3g86g92g80g69g82g79g86g3g68g81g71g3g68g69g69g85g72g

13、89g76g68g87g76g82g81g86 . 14 Test requirements for the frequency band 0 Hz g100 g100 3 000 MHz 34.1 General . 34.2 Induced lead current . 4g23g17g22g3 g51g85g82g87g72g70g87g76g82g81g3g73g85g82g80g3g83g72g85g86g76g86g87g76g81g74g3g80g68g79g73g88g81g70g87g76g82g81g3g68g87g87g85g76g69g88g87g68g69g79g72

14、g3g87g82g3g68g80g69g76g72g81g87g3g72g79g72g70g87g85g82g80g68g74g81g72g87g76g70g3g191g72g79g71g86 . 114.4 Temporary response to continuous wave sources 214.5 Protection from sensing EMI as cardiac signals 24g23g17g25g3 g51g85g82g87g72g70g87g76g82g81g3g73g85g82g80g3g86g87g68g87g76g70g3g80g68g74g81g72g

15、87g76g70g3g191g72g79g71g86g3g82g73g3g192g88g91g3g71g72g81g86g76g87g92g3g88g83g3g87g82g3g20g3g80g55 .34g23g17g26g3 g51g85g82g87g72g70g87g76g82g81g3g73g85g82g80g3g86g87g68g87g76g70g3g80g68g74g81g72g87g76g70g3g191g72g79g71g86g3g82g73g3g192g88g91g3g71g72g81g86g76g87g92g3g88g83g3g87g82g3g24g19g3g80g55 .3

16、5g23g17g27g3 g51g85g82g87g72g70g87g76g82g81g3g73g85g82g80g3g36g38g3g80g68g74g81g72g87g76g70g3g191g72g79g71g3g72g91g83g82g86g88g85g72g3g76g81g3g87g75g72g3g85g68g81g74g72g3g82g73g3g20g3g78g43g93g3g87g82g3g20g23g19g3g78g43g93 .364.9 Test requirements for the frequency range of 450 MHz g100 g100 3 000 M

17、Hz .375 Testing above frequency of 3 000 MHz 41g25g3 g51g85g82g87g72g70g87g76g82g81g3g82g73g3g71g72g89g76g70g72g86g3g73g85g82g80g3g40g48g3g191g72g79g71g86g3g72g81g70g82g88g81g87g72g85g72g71g3g76g81g3g68g3g87g75g72g85g68g83g72g88g87g76g70g3g72g81g89g76g85g82g81g80g72g81g87 41g25g17g20g3 g51g85g82g87g

18、72g70g87g76g82g81g3g82g73g3g87g75g72g3g71g72g89g76g70g72g3g73g85g82g80g3g71g68g80g68g74g72g3g70g68g88g86g72g71g3g69g92g3g75g76g74g75g16g73g85g72g84g88g72g81g70g92g3g86g88g85g74g76g70g68g79g3g72g91g83g82g86g88g85g72 41g25g17g21g3 g51g85g82g87g72g70g87g76g82g81g3g82g73g3g87g75g72g3g71g72g89g76g70g72g3

19、g73g85g82g80g3g71g68g80g68g74g72g3g70g68g88g86g72g71g3g69g92g3g72g91g87g72g85g81g68g79g3g71g72g191g69g85g76g79g79g68g87g82g85g86 427 Additional accompanying documentation467.1 Disclosure of permanently programmable sensitivity settings 467.2 Descriptions of reversion modes 467.3 Known potential haza

20、rdous behaviour46g36g81g81g72g91g3g36g3g11g76g81g73g82g85g80g68g87g76g89g72g12 Rationale .47g36g81g81g72g91g3g37g3g11g76g81g73g82g85g80g68g87g76g89g72g12 Rationale for test frequency ranges 58g36g81g81g72g91g3g38g3g11g76g81g73g82g85g80g68g87g76g89g72g12 Code for describing modes of implantable gener

21、ators .63g36g81g81g72g91g3g39g3g11g81g82g85g80g68g87g76g89g72g12 Interface circuits .65g36g81g81g72g91g3g40g3g11g76g81g73g82g85g80g68g87g76g89g72g12 Selection of capacitor Cx70g36g81g81g72g91g3g41g3g11g81g82g85g80g68g87g76g89g72g12 Calibration of the injection network (Figure D.5) .71g36g81g81g72g91

22、g3g42g3g11g81g82g85g80g68g87g76g89g72g12 Torso simulator .73g36g81g81g72g91g3g43g3g11g81g82g85g80g68g87g76g89g72g12 Dipole antennas 76g36g81g81g72g91g3g44g3g11g81g82g85g80g68g87g76g89g72g12 Pacemaker/ICD programming settings 78g36g81g81g72g91g3g45g3g11g81g82g85g80g68g87g76g89g72g12 Simulated cardiac

23、 signal .80g36g81g81g72g91g3g46g3g11g81g82g85g80g68g87g76g89g72g12 Calculation of net power into dipole antenna .81g36g81g81g72g91g3g47g3g11g76g81g73g82g85g80g68g87g76g89g72g12g3g47g82g82g83g3g68g85g72g68g3g70g68g79g70g88g79g68g87g76g82g81g86 85g36g81g81g72g91g3g48g3g11g76g81g73g82g85g80g68g87g76g89

24、g72g12 Correlation between levels of test voltages used in this International Standard g68g81g71g3g86g87g85g72g81g74g87g75g86g3g82g73g3g85g68g71g76g68g87g72g71g3g191g72g79g71g86 90g37g76g69g79g76g82g74g85g68g83g75g92 .96BS ISO 14117:2012ISO 14117:2012(E)Forewordg44g54g50g3g11g87g75g72g3g44g81g87g72g

25、85g81g68g87g76g82g81g68g79g3g50g85g74g68g81g76g93g68g87g76g82g81g3g73g82g85g3g54g87g68g81g71g68g85g71g76g93g68g87g76g82g81g12g3g76g86g3g68g3g90g82g85g79g71g90g76g71g72g3g73g72g71g72g85g68g87g76g82g81g3g82g73g3g81g68g87g76g82g81g68g79g3g86g87g68g81g71g68g85g71g86g3g69g82g71g76g72g86g3g11g44g54g50g3 g

26、80g72g80g69g72g85g3 g69g82g71g76g72g86g12g17g3 g55g75g72g3 g90g82g85g78g3 g82g73g3 g83g85g72g83g68g85g76g81g74g3 g44g81g87g72g85g81g68g87g76g82g81g68g79g3 g54g87g68g81g71g68g85g71g86g3 g76g86g3 g81g82g85g80g68g79g79g92g3 g70g68g85g85g76g72g71g3 g82g88g87g3 g87g75g85g82g88g74g75g3 g44g54g50g3g87g72g7

27、0g75g81g76g70g68g79g3g70g82g80g80g76g87g87g72g72g86g17g3g40g68g70g75g3g80g72g80g69g72g85g3g69g82g71g92g3g76g81g87g72g85g72g86g87g72g71g3g76g81g3g68g3g86g88g69g77g72g70g87g3g73g82g85g3g90g75g76g70g75g3g68g3g87g72g70g75g81g76g70g68g79g3g70g82g80g80g76g87g87g72g72g3g75g68g86g3g69g72g72g81g3g72g86g87g68

28、g69g79g76g86g75g72g71g3g75g68g86g3g87g75g72g3g85g76g74g75g87g3g87g82g3g69g72g3g85g72g83g85g72g86g72g81g87g72g71g3g82g81g3g87g75g68g87g3g70g82g80g80g76g87g87g72g72g17g3g44g81g87g72g85g81g68g87g76g82g81g68g79g3g82g85g74g68g81g76g93g68g87g76g82g81g86g15g3g74g82g89g72g85g81g80g72g81g87g68g79g3g68g81g71g

29、3g81g82g81g16g74g82g89g72g85g81g80g72g81g87g68g79g15g3g76g81g3g79g76g68g76g86g82g81g3g90g76g87g75g3g44g54g50g15g3g68g79g86g82g3g87g68g78g72g3g83g68g85g87g3g76g81g3g87g75g72g3g90g82g85g78g17g3g44g54g50g3g70g82g79g79g68g69g82g85g68g87g72g86g3g70g79g82g86g72g79g92g3g90g76g87g75g3g87g75g72g3g44g81g87g72

30、g85g81g68g87g76g82g81g68g79g3g40g79g72g70g87g85g82g87g72g70g75g81g76g70g68g79g3g38g82g80g80g76g86g86g76g82g81g3g11g44g40g38g12g3g82g81g3g68g79g79g3g80g68g87g87g72g85g86g3g82g73g3g72g79g72g70g87g85g82g87g72g70g75g81g76g70g68g79g3g86g87g68g81g71g68g85g71g76g93g68g87g76g82g81g17g44g81g87g72g85g81g68g87

31、g76g82g81g68g79g3g54g87g68g81g71g68g85g71g86g3g68g85g72g3g71g85g68g73g87g72g71g3g76g81g3g68g70g70g82g85g71g68g81g70g72g3g90g76g87g75g3g87g75g72g3g85g88g79g72g86g3g74g76g89g72g81g3g76g81g3g87g75g72g3g44g54g50g18g44g40g38g3g39g76g85g72g70g87g76g89g72g86g15g3g51g68g85g87g3g21g17g55g75g72g3g80g68g76g81g

32、3g87g68g86g78g3g82g73g3g87g72g70g75g81g76g70g68g79g3g70g82g80g80g76g87g87g72g72g86g3g76g86g3g87g82g3g83g85g72g83g68g85g72g3g44g81g87g72g85g81g68g87g76g82g81g68g79g3g54g87g68g81g71g68g85g71g86g17g3g39g85g68g73g87g3g44g81g87g72g85g81g68g87g76g82g81g68g79g3g54g87g68g81g71g68g85g71g86g3g68g71g82g83g87g7

33、2g71g3g69g92g3g87g75g72g3g87g72g70g75g81g76g70g68g79g3g70g82g80g80g76g87g87g72g72g86g3g68g85g72g3g70g76g85g70g88g79g68g87g72g71g3g87g82g3g87g75g72g3g80g72g80g69g72g85g3g69g82g71g76g72g86g3g73g82g85g3g89g82g87g76g81g74g17g3g51g88g69g79g76g70g68g87g76g82g81g3g68g86g3g68g81g3g44g81g87g72g85g81g68g87g76

34、g82g81g68g79g3g54g87g68g81g71g68g85g71g3g85g72g84g88g76g85g72g86g3g68g83g83g85g82g89g68g79g3g69g92g3g68g87g3g79g72g68g86g87g3g26g24g3g8g3g82g73g3g87g75g72g3g80g72g80g69g72g85g3g69g82g71g76g72g86g3g70g68g86g87g76g81g74g3g68g3g89g82g87g72g17g36g87g87g72g81g87g76g82g81g3g76g86g3g71g85g68g90g81g3g87g82g

35、3g87g75g72g3g83g82g86g86g76g69g76g79g76g87g92g3g87g75g68g87g3g86g82g80g72g3g82g73g3g87g75g72g3g72g79g72g80g72g81g87g86g3g82g73g3g87g75g76g86g3g71g82g70g88g80g72g81g87g3g80g68g92g3g69g72g3g87g75g72g3g86g88g69g77g72g70g87g3g82g73g3g83g68g87g72g81g87g3g85g76g74g75g87g86g17g3g44g54g50g3g86g75g68g79g79g3

36、g81g82g87g3g69g72g3g75g72g79g71g3g85g72g86g83g82g81g86g76g69g79g72g3g73g82g85g3g76g71g72g81g87g76g73g92g76g81g74g3g68g81g92g3g82g85g3g68g79g79g3g86g88g70g75g3g83g68g87g72g81g87g3g85g76g74g75g87g86g17g44g54g50g3g20g23g20g20g26g3g90g68g86g3g83g85g72g83g68g85g72g71g3g69g92g3g55g72g70g75g81g76g70g68g79g

37、3g38g82g80g80g76g87g87g72g72g3g44g54g50g18g55g38g3 g20g24g19g15g3 Implants for surgeryg15g3g54g88g69g70g82g80g80g76g87g87g72g72g3g54g38g3 g25g15g3Active implants.g44g54g50g3g20g23g20g20g26g3g76g86g3g69g68g86g72g71g3g82g81g3g36g49g54g44g18g36g36g48g44g3g51g38g25g28g29g21g19g19g26g17g3g55g75g72g3g85g7

38、2g79g68g87g76g82g81g86g75g76g83g3g69g72g87g90g72g72g81g3g87g75g72g3g71g82g70g88g80g72g81g87g86g3g76g86g3g68g71g71g85g72g86g86g72g71g3g76g81g3g36g17g21g17g23g17iv ISO 2012 All rights reservedBS ISO 14117:2012ISO 14117:2012(E)Introductiong55g75g72g3g81g88g80g69g72g85g3g68g81g71g3g87g75g72g3g87g92g83g7

39、2g86g3g82g73g3g72g79g72g70g87g85g82g80g68g74g81g72g87g76g70g3g11g40g48g12g3g72g80g76g87g87g72g85g86g3g87g82g3g90g75g76g70g75g3g83g68g87g76g72g81g87g86g3g90g76g87g75g3g68g70g87g76g89g72g3g76g80g83g79g68g81g87g68g69g79g72g3g70g68g85g71g76g82g89g68g86g70g88g79g68g85g3g71g72g89g76g70g72g86g3g68g85g72g3g

40、72g91g83g82g86g72g71g3g76g81g3g87g75g72g76g85g3g71g68g92g16g87g82g16g71g68g92g3g68g70g87g76g89g76g87g76g72g86g3g75g68g89g72g3g83g85g82g79g76g73g72g85g68g87g72g71g3g82g89g72g85g3g87g75g72g3g83g68g86g87g3g87g90g82g3g71g72g70g68g71g72g86g17g3g55g75g76g86g3g87g85g72g81g71g3g76g86g3g72g91g83g72g70g87g72g

41、71g3g87g82g3g70g82g81g87g76g81g88g72g17g3g55g75g72g3g76g81g87g72g85g68g70g87g76g82g81g3g69g72g87g90g72g72g81g3g87g75g72g86g72g3g72g80g76g87g87g72g85g86g3g68g81g71g3g68g70g87g76g89g72g3g76g80g83g79g68g81g87g68g69g79g72g3g70g68g85g71g76g82g89g68g86g70g88g79g68g85g3g71g72g89g76g70g72g86g3g11g83g68g70g7

42、2g80g68g78g72g85g86g3g68g81g71g3g76g80g83g79g68g81g87g68g69g79g72g3g70g68g85g71g76g82g89g72g85g87g72g85g3g71g72g191g69g85g76g79g79g68g87g82g85g86g15g3g82g85g3g44g38g39g86g12g3g76g86g3g68g81g3g82g81g74g82g76g81g74g3g70g82g81g70g72g85g81g3g82g73g3g83g68g87g76g72g81g87g86g15g3g76g81g71g88g86g87g85g92g3

43、g68g81g71g3g85g72g74g88g79g68g87g82g85g86g15g3g74g76g89g72g81g3g87g75g72g3g83g82g87g72g81g87g76g68g79g3g79g76g73g72g16g86g88g86g87g68g76g81g76g81g74g3g81g68g87g88g85g72g3g82g73g3g87g75g72g86g72g3g71g72g89g76g70g72g86g17g3g55g75g72g3g85g76g86g78g86g3g68g86g86g82g70g76g68g87g72g71g3g90g76g87g75g3g86g8

44、8g70g75g3g76g81g87g72g85g68g70g87g76g82g81g86g3g76g81g70g79g88g71g72g3g71g72g89g76g70g72g3g76g81g75g76g69g76g87g76g82g81g3g82g85g3g71g72g79g76g89g72g85g92g3g82g73g3g76g81g68g83g83g85g82g83g85g76g68g87g72g3g87g75g72g85g68g83g92g3g87g75g68g87g15g3g76g81g3g87g75g72g3g90g82g85g86g87g3g70g68g86g72g15g3g7

45、0g82g88g79g71g3g85g72g86g88g79g87g3g76g81g3g86g72g85g76g82g88g86g3g76g81g77g88g85g92g3g82g85g3g83g68g87g76g72g81g87g3g71g72g68g87g75g17g44g81g3g85g72g70g72g81g87g3g92g72g68g85g86g15g3g82g87g75g72g85g3g68g70g87g76g89g72g3g76g80g83g79g68g81g87g68g69g79g72g3g70g68g85g71g76g82g89g68g86g70g88g79g68g85g3g

46、71g72g89g76g70g72g86g3g75g68g89g72g3g72g80g72g85g74g72g71g15g3g80g82g86g87g3g81g82g87g68g69g79g92g3g71g72g89g76g70g72g86g3g87g75g68g87g3g83g72g85g73g82g85g80g3g87g75g72g3g73g88g81g70g87g76g82g81g3g82g73g3g76g80g83g85g82g89g76g81g74g3g70g68g85g71g76g68g70g3g82g88g87g83g88g87g3g69g92g3g82g83g87g76g80g

47、76g93g76g81g74g3g89g72g81g87g85g76g70g88g79g68g85g3g86g92g81g70g75g85g82g81g92g15g3g76g81g3g68g71g71g76g87g76g82g81g3g87g82g3g83g72g85g73g82g85g80g76g81g74g3g83g68g70g72g80g68g78g72g85g3g82g85g3g44g38g39g3g73g88g81g70g87g76g82g81g17g36g79g87g75g82g88g74g75g3g87g75g72g86g72g3g71g72g89g76g70g72g86g3g7

48、0g68g81g3g71g72g79g76g89g72g85g3g68g81g3g68g71g71g76g87g76g82g81g68g79g3g87g75g72g85g68g83g92g3g90g76g87g75g3g85g72g86g83g72g70g87g3g87g82g3g83g68g70g72g80g68g78g72g85g86g3g68g81g71g3g44g38g39g3g71g72g89g76g70g72g86g15g3g80g82g86g87g3g82g73g3g87g75g72g76g85g3g85g72g84g88g76g85g72g80g72g81g87g86g3g70

49、g82g81g70g72g85g81g76g81g74g3g40g48g3g70g82g80g83g68g87g76g69g76g79g76g87g92g3g68g85g72g3g86g76g80g76g79g68g85g3g86g82g3g87g75g68g87g15g3g76g81g3g80g82g86g87g3g70g68g86g72g86g15g3g87g75g72g3g70g82g81g70g72g83g87g86g3g87g75g68g87g3g68g83g83g79g92g3g87g82g3g83g68g70g72g80g68g78g72g85g86g3g68g79g86g82g3g68g83g83g79g92g3g87g82g3g38g53g55g16g51g3g71g72g89g76g70g72g86g15g3g68g81g71g3g87g75g72g3g68g83g83g85g82g83g85g76g68g87g72g3g90g68g92g3g87g82g3g87g72g86g87g3g68g3g38g53g55g16g51g3g71g72g89g76g70g72g3g76g86g3g86g76g80g76g79g68g85g3g87g82g3g87g75