経皮的冠動脈形成術用カテーテル承認基準の制定について
Contents
1.2.
3. 1 6
4. 4 1 4 1 1 STERILE 4 1 2 4 6 4 1 2
5. 16 169 16 169 2
6. 17 3 10 0310003 acea st 2 1 6 5 JIS T 14971 16
7. GMP QM S 17 3 30 0330001 4 OR 4 7
8. JIS T 14971 2 1 6 1 2 6 1 4 JIS T 14971 8
9. 959 99 9 gt NP RBP d e f g h
10. 4 5 hhANN 1 4
11. 3 JIS T 14971 2 4 a
12. ISO 10555 4 A FDA 95 90 40 4 1 7 ISO 594 1 ISO 594 2 EN 1707 4 2
13. 0216002 17 2 16 2 1 2
14. 2 2 5 7 16 298 1 81 17 4 1 1 1 tw 1 3
15. 4 5 6
16. 3 4 5
17. 3 16 169 9 4 16 169
18. 3 4
19. 13 2 3
20. 2 3
21. 2 17 2 16 021 6002 2 2 3
22. 5 1 1 2
23. GMP QM 8 S 17 3 30 0330001 4 4 16 169 9
24. 2 2 O d mmm o GO Le O h O x x i O 1 x x O x 2 ae 1
25. 2 3 10
26. 4 5 a b d f g h 1 j k 1 m 4 6 0D Outside Outer diameter Effective Usable 1engtb STERILE 4 3 3 Diameter of the inflated balloons Effective Usable 1ength of the balloon Maximum Max Guidewire GW diameter X Position s of radio detectable radiopaque markers kPa RBP
27. 9
28. 6 7 8 am
29. 2 1 6 1 7 6 3 1 6 3 2 6 3 3 c 17 3 10 0310003 2 1 6 5 JIS T 14971 2 1 6 4 JIS T 14971 JIS T 14971 JIS T 14971
30. 14 96 2 14 1 19 2 1 17 2 16 0216002 2 17 3 31
31. 3 4 3 5 3 6 Effective 1ength Usable 1ength 3 7 Outside diameter Outer diameter 3 8 3 9 NP Nomina1 Pressure 3 10 RBP Rated Burst Pressure 3 11 Balloon Profile 3 12
32. 10 JIS T 14971
33. N 15 2 NN 3
34. 12 2 1 3
35. PTCA 4 2 5 1 PTCA
36. to 2 1 ISO 10555 1 1995 Sterile single use intravascular catheters Part 1 General requirements ISO 10555 1 2 2 ISO 10555 4 1996 Sterile single use intravascular catheters Part 4 Balloon dilatation catheters ISO 10555 4 2 3 ISO 594 1 1986 Conical fittings with a 6 Luer taper for syringes needles and certain other medical equipment Part 1 General requirements ISO 594 1 2 4 1SO 594 2 1998 Conical fittings with 6 Luer taper for syringes needles and certain other medical equipment Part 2 Lock fittings IS0 594 2 2 5 EN 1707 1997 Conical fittings with a 6 Luer taper for syringes need es and certain other medical equipment EN 1707 2 6 Draft Guidance for the Submission of Research and Marketing Applications for Interventiona 1 Cardiology Devices PTCA Catheters Atherectomy Catheters Lasers Intravascular Stents 1994 FDA 2 7 17 3 30
37. 2 3 2 1 6 1 2 JIS T 14971
38. JIST 14971 2 1 6 1 2 JIS T 14971 2 1 6 1 2 JIS T 14971 JIS T 14971
39. 16 169 JIS T 14971 JIS T 14971 2
40. 6 JIS T 14971 0401038 17 4 1 2 1 4 1 3 4 1 5 4 1 6 7
41. X 4 3 3 3 1 Re 3 2 3 3 a NPD multidiameter balloons b c 3 4 4
42. 0330001 G MP QMS 4 4 2 8 SO 11135 1994 Medical Devices Validation and routine control of ethylene oxide sterilisation for medica devices ISO 11135 2 9 ISO11137 1995 Sterilization of health care products Requirments for validation and routine contro Radiation sterilization ISO 11137 2 10 EN 550 1994 Sterilization of medical devices Vatidation and routine control of ethylene oxide sterilization EN 550 2 11 EN 552 1994 Sterilization of medical devices Validation and routine control of sterilization by irradiation EN 552 2 12 15 2 13 0213001 2 13 1S0 10993 1 2003 Biologica1 evaluation of medical devices Part 1 Evaluation and testi
43. ISO 10555 1 A 4 1 5 2 1 3 N 0 55mm ISO 10555 1 B 1 mn N gt 0 55 lt 0 75 3 gt 0 75 lt 1 15 5 1 15 1 85 10 lt 1 85 15 ES 2 4 1 6
44. 0401038 1 7 4 1 35 145 14 1 19 2 1 14 9 19 2 5 I VD ul CU 1 1 1
45. JIS T 14971 5 16 169 JIS T 14971
46. 15 2 13 0213001 IS0 10993 4 1 3 4 1 4
47. 4 NN 5 6 7
48. 0331012 1 1
49. Rated Burst Pressure Rated kPa NP Nominal Pressure Nominal MRI 4 1 2 4 5 IS014971 17184024 a b c
50. ng IS0 10993 1 2 14 JIS T 0993 1 1 2 15 ISO 14971 2000 Medical deyices Application of risk management to medical devices ISO 14971 2 16 JIS T 14971 2003 3 1 as 5 1 3 2 3 3
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