別添2経皮的冠動脈形成術用カテーテル承認基準
Contents
1.2.
3. 6
4. JIST 14971 2 1 6 4 J1S T 14971 JIS T 14971
5. 1 5
6. GMPQM S 17 3 30 0330001 4 4 8 16 169 9
7. 2 1 6 1 7 5 6 3 1 6 3 2 6 3 3 ec 17 3 10 0310003 2 1 6 5 9
8. 4 1 4 1 1 STERILE 4 1 2 4 6 1 2 15 2 13 0213001
9. 4 5 JIST 14971
10. 10 JIS T 14971
11. 2 1 6 1 2 6 1 4 6 IS T 14971 8
12. 95 99 9 NP RBP 9 f 8 hb i
13. 5 16 169 16
14. 4 3 16 169
15. JIS T 14971 2 1 6 1 2 JIS T 14971 2 1 6 1 2 JTS T 14971
16. 4 H 5 11
17. 5 1 4 2 3
18. lh 2 1 6 5 JIST 14971 16 0216002 17 2 16 2 1 2
19. a b c d f 8 hb 1 3 ks 1 m 4 6 4 1 2 4 5 OD Outside Outer diameter Effective Usabl1e 1ength STERILE 9 4 3 3 Diameter of the inflated ba11oons BEFfective Usab1e 1ength of the ba11oon PR Maximum Max Guidewire GW diameter X Position s of radqio detectab1e radiopaque markers kPa RBP Rated Burst Pressure Rated kPa N
20. 2 1 3 N 0 55mm TSO 10555 1 B 1 mm N 0 55 lt 0 75 3 0 75 lt 1 15 5 1 15 lt 1 85 10 1 85 15 i ban 4 2 41 6
21. 1S0 10555 4 A FDA 95 90 40 4 1 7 TIS0 594 1 1S0 594 2 EN 1707 4 2 X 43
22. 10 2 3
23. 8 1 2
24. 4 5
25. 5 6 _ 7
26. 16 169 JIS T 14971 5 5 JIS T 14971 2
27. 3 6 Effective length Usable 1ength 3 7 Outside diameter Outer diameter 3 8 3 9 NP Nomina Pressure 1 3 10 RBP Rated Burst Pressure 3 11 Ba11oon Profi1e 3 12
28. TS0 10993 4 1 3 4 1 4 ISO 10555 1 A 4 1 5
29. Ni 6 GMP QM S 17 3 30 0330001 4 4 7
30. 4 3 ny Tt 3 3 a 4
31. 2 JIS T 14971 2 1 6 1 2 3 JTS T 14971
32. 16 169 JIS T 14971 JIS T 14971 0401038 17 4 1 2 1 4 1 3 4 1 5 41 6 7
33. ko o I Po to tS Ro DY 1 TISO 10555 1 1995 Sterile single use intravascular catheters Part 1 General requirements 1S0 10555 1 2 TSO 10555 4 1996 Steri1e Sing e use intravascular thet Part 4 Balloon dilatation catheters IS0 10555 4 3 IS0 594 1 1986 Conica1 fittings witha6 Luer taper for syringes needles and certain other medica equipment Part 1 General requirements IS0 594 1 4 IS0 594 2 1998 Conica1 fittings with 6 Luer taper for syringes needles and certain other medical eguipment Part 2 Lock fittings 1S0 594 2 5 EN 1707 1997 Conical fittings with a 6 Luer taper for syringes needles and certain other medica equipment EN 1707 6 Draft Guidance for the Submission of Research and Marketing Applications for Interventiona Cardiology Devices PTCA Catheters Atherectomy Catheters Lasers Intravascular Stents 1994 FDA 7 17 3 30 0330001 G MP
34. 2 3 17 3 10 0310003
35. 5 1 1 PTCA r
36. deyices TS0 14971 2 16 JIS T 14971 2003 3 1 1 3 2 3 3 3 4 3 5
37. 2 3 4
38. 3 4 3 1 4 3 2 4 3 3 a NP multidiameter ba11oons b c 6232 3 4 4 4 5
39. N NN 1 3 6 7 2
40. SPDT JIS T 14971 2 3
41. 169 3
42. 2 3 io 2 4 5
43. 2 b Oo lc o 9 9 le lg h O x 2 ed 1
44. 16 169 JTS T 14971 6 5
45. 2 2 5 7 16 298 1 81 17 4 1 1 1 2 1 3 PTCA 4 2
46. QMS 4 4 8 IS0 11135 1994 Medica Devices Validation and routine control of ethylene oxide sterilisation for medica1 devices ISO 11135 9 TIS011137 1995 Steri1ization of health care products Requirments for validation and routine contro1 Radiation steri1ization IS0 11137 10 EN 550 1994 Steri1ization of medica deyices Validation and oUtine control of ethylene oxide sterilization EN 550 11 EN 552 1994 Sterilization of medical devices Validation and routine control of sterilization by irradiation EN 552 12 15 2 13 0213001 13 IS0 10993 1 2003 Biological evaluation of medica1 devices Part 1 Evaluation and testing ISO 10993 1 14 JIS T 0993 1 1 15 IS0 14971 2000 Medical devices Application of risk management to medica1
47. P Nomina1 Pressure Nomina1 MRI IS014971 17184024 i a b c
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