薬食発第 03250ー3 号 平成20年3月 2 5 日
Contents
1.2.
3. 16 169 1 4 2 2 4 2 5 4 2 5 1 4 2 5 2 1 5 JIS T 0601 1 1 6
4. 0 3 4
5. JIS T 0601 1 2 1 JIS 7
6. JIS T 0601 1 1 6 1 5 17 3 10 0810003 JIS T 14971
7. 16 169 GMP QMS 0380001 17 3 30 4 4 1 5 1 5 7
8. JIS T 14971 1 4 2 3 4 2 4 JIS T 14971 1
9. 1 42 JIS T 14971
10. 5 16 169 JIS T 14971 JIS T 14971 6
11. 5 5 C ea 4 2 8 2 JIS C 1602 4 2 9 JIS B 7505 4 2 10
12. 1 2 JIS T 14971 1 4 2 8
13. 16 169 GMP QMS 0380001 17 3 30 4 4 1 42 10 8
14. a 3 4 16
15. 1 41 42 JIS T 0601 1 1 7
16. 4 2 11 25ug g ISO10993 7 4 2 12 4 2 1 4 1 3 1 4 1 4 2 ASTM F882 84 12 Tractive Force Test Method 4 2 12 1 ASTM F882 84 12 Tractive Force Test Method 3 2 15 25 15 17 6 30
17. ASTM F882 84 7 3 2 Ambient Concentrations of Nitrous Oxide 4 2 5 2 5 4 2 5 3 ASTM F882 84 10 Test Method for Determining Ambient Concentration of Nitrous Oxide 1 1 28 32 2 13 1 142 gt 17 0 30qn
18. 25 42 43 52 56 57 59 1 5 2 JIS T 14971 3 JIST 14971
19. ASTM F882 84 6 2 11 2 1 16 169 JIS T 14971
20. JIS T 14971 1 4 2 5 4 2 5 1 4 2 5 2 3
21. 2 19 6MPa 30 4 2 1 2 JIST 0993 1 1
22. 0cm 9Ogn dn 3 2 60 12 ASTM 12 25ppm 4 2 6 60
23. 4 2 7 60C 4 2 7 1 ASTM F882 84 11 Test Method for Determining Closed Cryotip Temperature Reproducibihty 3 1 1000mL 1000mL 30C 2
24. JIS T 14971 0218001 15 2 13 1 4 2 1 2 1 42 JIS T 0601 1 1 43 1 2
25. ASTM F882 84 7 4 Thermal Insulation 4 2 3 ASTM F882 84 3 4 1 2 42 4 JIS B 8246 4 2 5 ASTM F882 84 7 3 1 Cryogen Exhaust 4 2 5 1
26. 3 16 169 4 16 169 JIS T 14971
27. 16 169 1 5 2 5 9 16 169
28. 0310008 JIST 14971 JIS T 0601 1 1 6 8 1 4 2 3 4 2 4 5 2 9
29. Raf 5 1 1 2 JIST0601 1 1 JIST 0601 1 2 1 2 JIST0993 1 JIS C 1602 JIS B 7505 _ JIS B 8241 JIS B 8246 ASTM F882 84 Standard Performance and Safety Specification for Cryosurgical Medical Instruments ISO10993 7 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals 3
30. 1 5 2 3
31. GS i ni 3 1 9 6 2 NUMEIe 1 4 1 1 9 2 1 UI EE 8 1 7 2 1 6 0216002 HMI 4 2
32. 5 6 NSR 7 8
33. 1 4 2 2 1 4 1 42 7 4 2 8 4 2 9 2
34. JIS T 0601 1 JIS T 0601 1 2 JIS T 0993 1 JIS C 1602 JIS B 7505 JIS B 8241 JIS B 8246 ASTM F882 84 ISO10993 7 3 1 3 2 3 3 3 4 3 5 2 2
35. JIS T 14971 _ JIST 0601 1 2 1 2 36 202 JIS T 14971 2 JIS T 0601 1 1
36. GMP QMS 0330001 17 8 30 4 4 1 0 16 169 1 5 1 4 17 3 10
37. 1 7 3 3 1 031012 2 5 7 16 298 1 956 20 3 25 1 2 1 3 4 2
38. 3 4 JIS T 14971 JIS T 0601 1 1 6 3 5
39. JIS T 14971 JIS T 0601 1 1 21 23 24 25 45 1 4 2 JIST0601 1 1 10 2 2 49 JIST 0601 1 2 1
40. 45 5 6 5 5 1 OR 5 1 1 A RAs 1 2 3 Hz V 6 A VA W 7 3 JIS T 0601 1 6 1 5 1 2 1 JIS T 0601 1 6 1 6 7 7
41. 2 86 201 JIST 0601 1 2 1 2 86 202 7 JIS T 0601 1 1 7
42. ASTM F882 84 9 Test Method for Mechanical Integrity 7 2 Mechanical mtegrity 39 JIS B 8241 1 D 30
43. 1 4 2 5 4 2 5 1 42 5 2 6 IS T 0601 1 1 44 4 56 11 9 JST 14971 1 4 2 5 4 2 5 1 4 2 5 2
44. 1 6 0216002 17 3 81 2 1 2 2
45. 2 36 202 1 6 4 2 5 4 2 5 1 4 2 5 2 JIS T 0601 1 1 56 11 d JIST 14971
46. 169 JIS T 0601 1 1 10 56 8 a 57 58 1 4 2 3 42 4 JIS T 14971 5 TS T 0601 1 1 42
47. 4 2 1 3 JIS T0601 1 23 4 2 1 4 ASTM F882 84 3 1 1 closed cryotip 4 2 1 4 1 1 1 a 10
48. JIS TO601 1 21 4 2 1 1 ASTM F882 84 7 2 Mechanical Integrity 4 2 1 1 1 ASTM F882 84 9 Test Method for Mechanical Integrity 3 3 5 JIS T 0601 1 25 43 1 44 4 45 4 2 1 1 2
49. 3 4 5 6 7 3 60 3 5 2 ee 4 2 8
50. 0325013 2 0 3 2 5 3 5 1 4 5 1 4 1 19 2 1 1 4 9 1 9 2 5 SE I VD 1 0 2 10 216002 ep 2 2
51. JIS T 14971 JIS T 0601 1 1 6 3 1 1 2
52. 3 6 4 1 JIS T 0601 1 JIS T 0601 1 2 ASTM F882 84 Reapproved 2002 Standard Performance and Safety Specification for Cryosurgical Medical mstruments ASTM F882 84 Reapproved 2002 Standard Performance and Safety Specification for Cryosurgical Medical Instruments 3 1 1 closed cryotip 5 4 Monitoring Devices 6 Disclosure Labeling and Documentation Reduirements 7 2 Mechanical Integrity 7 3 1 Cryogen Exhaust 7 3 2 Ambient Concentrations of Nitrous Oxide 7 4 Thermal Insulation 9 Test Method for Mechanical Integrity 10 Test Method for Determining Ambient Concentration of Nitrous Oxide 11 Test Method for Determining Closed Cryotip Temperature Reproducibility 12 Tractive Force Test Method 13 Test Method for Determining the Accuracy of Temperature Monitors Cryotip and Tissue 4 2 4 2 1
53. 8 16 169 JIS T 0601 1 1 44 7 _
54. 19 20 58 1 3 IS T 0601 1 1 21 23 24 45 1 42 JHS T 14971 2
55. 1 7 10 3103 G3 4 KUURD 47 6 495 la 0 ASTM F882 84 9 1 20C ASTM F882 84 6 2 3 AST
56. 0630001 1 H JMDN 13700000 2 O 19mm 8 SmmR 30 2 C 1000mL 6Og 1 2 60g O 2 1000mL 30 2 O 3 I DT 45
57. 16 169 JIS T 0601 1 1 _44 4 44 7 16 169 JIS T 0601 1 1 44 4 44 7 2 3
58. 2 3 4 5 JIST 0601 1 2 1
59. 0 35 0mm 9 a 1 b eo2 0 4 0mm 0 C 2 0 20 0mm 1 2 i c 2 0 20 0mm d 2 0 5 0mm 1 3 a 10 0 40 0mm b p1 5 3 5mm 1 6 c 2 0 30 0mm 00 1 5 a 10 0 40 0mm b 1 5 3 5mm bt d 1 5 4 0mm 0 a 10 0 35 0mm b 2 0 4 0mm c 2 0 20 0mm 3 1 gt 4 gt a 20 0 35 0mm b p0 8 1 5mm 1 a a 10 0 35 0mm b pl 0 2 5mm a 10 0 35 0mm a a b qp1 0 2 5mm NT c 2 0 20 0mm 5 1 Bf a 20 0 60 0mm b e1 5 4 0mm c 2 0 20 0mm Q 1 ee d 4 0 12 0mm Ce a a 20 0 60 0mm b e1 5 4 0mm bf fF d 4 0 12 0mm 6 1 a 25 0 45 0mm b 01 0 2 0mm A NH Ei il fr a c 2 0 30 0mm 7 1 a a 15 0 60 0mm b pl1 0 3 0mm c 2 0 20 0mm o d 1 5 4 0mm ii 4 a 20 0 45 0mm 4 01 0 4 0 NI bf c 2 0 20 0mm i 2 a 10 0 40 0mm b 1 0 3 0mm c 2 0 20 0mm d 2 0 8 0mm 3 ol 42 2
60. 1 5 1 3 IS T 0601 1 6 6 1 JIS T 0601 1 56 3 a 3 1 4 1 2 3 5 1 5 OAS ein GR 5 2 Me
61. 1 4 2 5 1 0 4 2 7 4 2 8 4 2 9 2 mm
62. ASTM F882 84 13 Test Method for Determining the Accuracy of Temperature Monitors Cryotip and Tissue 4 2 8 1 ASTM F882 84 13 Test Method for Determining the Accuracy of Temperature Monitors Cryotip and Tissue 3 3 1 2 3
63. M F882 84 6 2 4 ASTM F882 84 6 2 5 AC ASTM F882 84 6 2 6 JIST 0601 1 A1 6 ASTM F882 84 6 2 7 ASTM F882 84 6 2 8 5 ASTM F882 84 6 2 10
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