植え込み型心臓ペースメーカー等承認基準の制定ついて（PDF：862KB）
Contents
1. 2 22. 2 ISO14708 1 2000 Hmplants for surgery Active implantable medical devices Part 1 General requirements for safety marking and for information to be provided by the manufacturer ISO14708 2 2005 Implants for surgery Active implantable medical devices Part 2 Cardiac pacemakers EN 28601 1992 Data elements ISO 8601 EN 45502 2 1 2003 Active implantable medical devices Part 2 1 Particular requirements for active implantable medical devices intended to treat bradyarrhythmia Cardiac pacemakers 60068 2 27 1993Basic environmental testing pro
3. 201 A e 6 1 3 2 IMO FI03 E lkQ 9 103 103 5000Q 1 Rr NE 4 ont ON A NR RC 30ms
4. 0 3 2 2 5 7 1 6 2 9 8 1 200 203 204 oN 206 19
5. 116 500Q2 1 Ri R Rr 100kQ 1 6 1 2 2 a Y se 116 PVARP t
6. 3 12AV 6 1 7 3 13 3 14 1 6 1 1 a 3 16 3 17 1 1 3 18
7. 5 109 2 s 1 2 1 a 2 1 6 109 1 1 s 1 1 110 10 2 111 111 2 2 t
8. 3 27 3 28 3 29 3 30 Rc 6 2 1 3 31 Z 6 2 2 3 32
9. 28 8 37C 2 9g 1 10 IMO 102 _ 102 62 1 6 2 1 R R Q 6 2 2 Z 50Q 2
10. Q amp A 1 1
11. 0 S Ri 0 V S V Z ak 5 ZL EK Rs Rs 2 kQ 6 1 4 t
12. O 3 1 4 9 6 2 1 4 1 1 9 2 1 1 7 2 1 6 0216002
13. 3 19 3 20 Z 6 1 3 Se 3 21 6 1 2 3 22 6 1 5 6 1 6 3 23 3 24 1 3 23 2 3 26 5
14. 1 3 A 6J1 3 7 2 6 1 1 3 8 2 6 1 1 3 9 NR 3 10 6 1 4 3 11
15. 1 eS 2 EE a NN a a 2 2 8 1 DT
16. 101 101 i eee 61D 6 1 1 9 0 2 6 1 1 6 1 1 0 5 6 1 2 IIIIETFPIIII 6 3 lt IMQ io 6 1 4 10 6 1 5 6 1 6 6 1 8 10 _ AV AM 6 17 61 9 39 6 Fe IMo
17. OC OO 100kQ 19 Rj C 119 AV 30ms 120 18 2 RR 1 6 5 2 DN AV 5 2 ph 120 AV AV ty ms 6 2
18. 3 40 RRT J 3 41 3 42 3 43 3 44 3 45 _3 46 3 47 4
19. 4 4 15 2 13 0213001 3 3 1 3 2 3 3 3 4
20. ts 6 1 1 300Q Rr 101 1 D Amax 3 1 Fi01 A F102 20 3 B 5 2402 1 lkQ 1 R
21. al e ms e V mA e ms mm 6 1 2 ea 2 1MO F103 1kQ 102 500Q 1 R 100kQ 1 Rr A 50ms 0
22. 2 E in 1 hp EE Ei Ce ss 110 A 1 2 1 2 1 a Ly i 1 a 3 1 p 112 113 112 3 2 1 2 a i a a Ns 112 A 1 1 H a 113 B tb
23. 6 ms 5 6 1 6 tp 6 1 4 104 6 1 2 2 t t 596 109 105 107 3 t 114 3 t 1 2 ia 5E 7 5 2 RI 0 7
24. 104 500Q 1 Ri Rr A Rg 100kO 1 inf 104 6 1 2 2 t t 5 10 105 2 105 t lt
25. 4 2 1 7 3 3 1 0331012 5 1 1 1 2 2 8 1439 12 3 28 528 12 10 5 No21
26. 33 396ruF Cr 122 63 4V 0 1V 0 5ms 0 05ms 100 2 R my Z 0 dt as vadt 0 20
27. 0302004 19 3 2 Er ea te er rd 3 5 1 4 5 1 4 1 1 9 2 1 4 9 1 9 2 5 2 I VD 1 1
28. 117 2 1 oe PVARP 117 PVARP 117 2 t 118 1 3 i EPVARP 7 ft 118 PVARP AV PVARP AV PVARP ms 6 1 9 AV F 103
29. 5 6 1 28 8 37 2 S00Q 1
30. d 50mm 0 8d 1 2d 10 33 396uF lt 2 Cr 121 0 M mm we 121 1Smm 10 10mm 122
31. 2 Love 106 107 NR 1 2 1 2 107 te Mk ms 6 1 5 G 108 300O 1 R R A R 100kQ 1 6 1 2 OR 2
32. Z 6 2 3 3 33 3 34 3 33 BOS 3 36 EOS AA 3 37 3 38 PSP 3 39
33. 3 2 1 A gt 1 8 4 2 1 RR I A RE 0 5 1 1
34. 2 114 2 tu ms 6 1 7AV 300Q 1 115 1 2 a pm 115 AV I AV ty ms 6 1 8 PVARP
35. cedures 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 EC 60068 2 47 EN 60068 2 64 1994 Environmental testing Part 2 Test methods Test Fh broad band random digital control and guidance JEC60068 2 64 ISO 5841 3 1992 Low profile connectors IS 1 for implantable pacemakers ANSUAAMI PC69 2000 Active implantable devices Electromagneic compatibility EMC iest protocols for implantable cardiac pacemaker and innplantable cadioverter defibriHators SO 10993 1 2003 Biological evaluation of medical devices Part 1 Evaluation and testing ISO 11134 1994 Sterilization of health care products Requirements for validation and routine control industrial moist heat sterilization ISO 11135 1994 Medical Devices Vahdation and routine control of ethylene oxide sterilisation for medical devices ISO 14971 2000 Medical devices Application of risk inanagernent to inedical devices JST14971 2003 17 3 30 0330001 GMP QMS 0
Download Pdf Manuals
Related Search