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Contents
1. 6 1 1 a 5009 1 Ri 101 1 9 D Amax 3 1 F101 A F102 202. 28 8 37C 2 500O 1 _ 101 sm sm 0 2 6 1 1 61 2 ET 6 1 3 lt 1MQ 0 IE H 6 x NM SA lt Ww gt lt IN 6 1 5 6 1 6 6 1 8 10 NO OM SM 2 a 1MQ
3. 3 17 1 lt 1 1 3 18 3 19 3 20 Z 6 1 3 3 21 6 1 2 _ 3 22 6 1 5 6 1 6 3 23
4. 3 38 PSP 3 39 3 40 RRT 3 41 3 42 3 43 3 44 3 45
5. 5 10 v 105 gt 12 1 2 e Hp 2 H f _ 105 t 106 v 107 1 2 5 H f a 106 te 1 2
6. a 5 5 111 5 1 I 2 2 St 112 13 3 B b G ms 15 6 1 6 tpr 6 1 4 104 6 1 2 2
7. 6 2 1 3 31 Zp 6 2 2 _3 32 Z 6 2 3 3 33 3 34 3 33 BOS 3 36 BOS 3 37
8. 3 24 1 3 23 2 3 26 3 27 3 28 3 29 3 30 Rc
9. H HH 107 te t ms 6 1 5 108 300Q 1 R Rr A Rr 100kO 1 92 108 6 1 2 2 t s 109 2
10. Rr 100kO 1 090 6 1 2 2 116 PVARP t 117 1 117 PVARP RR Et PARP 117 2 t i18 1 2 9 ft 118 PVARP
11. t t 5 10 105 1 107 3 _ 114 3 t 1 i 0 0 7 114 2 tp ms 6 1 7AV
12. 3 10 V 6 1 4 3 11 3 12AV 6 1 7 3 13 3 14 6 1 1 3 15 v ER 3 16
13. 120 0
14. AV PVARP AV PVARP P ms 6 1 9 AV F103 119 500Q 1 Rr RE C 119 AV 50ms
15. 3 2 3 3 3 4 v 3 9 3 6 6 1 1 3 7 2 6 1 1 3 8 2 6 1 1 3 9
16. 101 tp NN SID TA 6 240O 1 1kQ 1 RL ms V mA 6 ms 8 min 2 6 1 2 ea eneg 1MO F103 1kQ 102 300Q 1 R
17. 100kO 1 Rs A 50ms 0 3 e 201 102 A ex 6 1 3 Z _ 1MO F 103
18. 1kQ 103 _ 103 5000 1 Rr Ri Rr A Ri 10kQ 100kQ R 1 Rr 100kQ 1 30ms _ 0 S R 0 V
19. 300Q 1 115 RN 1 2 115 AV AV ty ms 16 6 1 8 PVARP 116 500Q 1 Ri Rr
20. _3 46 3 47 4 3 6 6 1
21. 1 1 2 ISO14708 1 _2000 Implants for surgery Active implantable medical devices Part 1 General reduirements for safety marking and for information to be provided by the Tmanufacturer ISO14708 2 2005 Implants for surgery Active implantable medical devices Par
22. 17 3 30 0330001 GMP QMS 4 4 1 2 13 0213001 _ 3 3 1 PD
23. s 1 1 ms 2 1 2 _ 109 i 1 1 s 1 1 110 ti 110 2 11 111 2 2 t 1 2 110 AN 1 2 1 2
24. 11 _ S NO PRR MULT V Z Rs 2 kQ 6 1 4 t 104 2000 1 R Rr A Rr 100kO 1 dd 104 6 1 2 2
25. t 2 Cardiac pacemakers EN 28601 1992 Data elements SO 8601 EN 45502 2 1 2003 Active implantable medical devices Part 2 1 Particular reduirements for active implantable medical devices intended to treat bradyarrhythmia Cardiac pacemakers _60068 2 27 1993Basic environmental testing NRN Part 2 Tests Test Ea Shock EC 60068 2 27 EN 60068 2 47 1999 Environmental testing Part 2 47 Test methods Mounting of components equipment and other articles for vibration impact and similar dynamic tests IEC 60068 2 47 _ EN 60068 2 64 1994 Environmental testing Part 2 Test methods Test Fh broad band random digital control and guidance EC60068 2 64 ISO 841 3 1992 Low profile connectors IS for implantable pacemakers ANSAAMI PC69 2000 Active implantable devices Electromagnetic BB BMC test protocols for implantable cardiac pacemaker and implantable cadioverter defibrillators ISO 10993 1 2003 Biological evaluation of medical devices Part 1 Evaluation and testing ISO 11134 1994 Sterilization of health care produgt Requirements for validation and routine control Industrial moist heat sterilization JSO 11135 1994 Medical Devices Validation and routine control of ethylene oxide sterilisation for medical devices ISO 14971 2000 Medical devices Application of risk management to medical devices JIS T 14971 2003
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