汎用冷凍手術ユニット承認基準の制定について
Contents
1. IS T 14971 JIS T 0601 1 JIS2. IST 0601 1 1 6 1 5 17 3 10 0310003
3. 5 6
4. 2 JIST 0601 1 1 JIS T 0601 1 2 1 2 JIST0993 1 1 JIS C 1602 JIS B 7505 JIS B 8241 JIS B 8246 ASTIM 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 J
5. 16 169 GMP Q MS 0330001 17 3 30 4 4 1 4 2 10 8
6. amp B 16 169 JIS T 14971 5 6
7. 5 2 1 2 17 3 10 0310003 6 3 4 5 0
8. JIS T0601 1 23 4 2 1 4 ASTM F882 84 3 1 1 closed cryotip 4 2 2 ASTM F882 84 7 4 Thermal Insulation 4 2 3
9. 3 2 60 12 ASTM 12 25ppm 4 2 6 60 C 4 2 7 60 C
10. ASTM F882 84 5 4 1 2 4 2 4 JIS B 8246 4 2 5 ASTM F882 84 7 3 1 Cryogen Exhaust 4 2 5 1 ASTM F882 84 7 3 2 Ambient Concentrations of Nitrous Oxide 4 2 5 2
11. 16 169 1 5 2 5 9 16 169 0
12. 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 ASTM F882 84 9 Test Method for Mechanical
13. 4 5C ew 2 4 5 ee 4 2 8 2 JIS C 1602 3 4 2 9 JIS B 7505 4 2 10 4 2 11
14. 4 2 7 1 ASTM F882 84 11 Test Method for Determining Closed Cryotip Temperature Reproducibility 3 1 1000mL 1000mL 30 C 2C 2 3 4
15. 2 JIS T 14971 0213001 15 2 13 4 2 1 2
16. 7 8 0 1 2 HIS T 14971
17. 0 16 169 JIS T 0601 1 1 10 56 3 a 57 58 1 4 2 8 4 2 4 MIS T 14971 5
18. 4 2 5 3 ASTM F882 84 10 Test Method for Determining Ambient Concentration of Nitrous Oxide 1 1 28 32 2 13 142 170 30gn gocm gocm
19. IST 0601 1 1 42 1 4 2 2 1 4 1 4 2 7 4 2 8 4 2 9 2
20. 2 1 W 1 4 2 7 4 2 8 4 2 9 3 4
21. MTS T 14971 UIS T 0601 1 1 6 3 5 f MIS T 14971 JIS T 0601 1 6 3
22. 1 42 IS T0601 1 43 1 UIS T 14971 1 4 2 5 4 2 5 1 4 2 5 2 3
23. B 16 169 IGT 0601 1 44 4 44 7 0 16 169 UIS T 0601 1 44 4 44 7 2
24. 3 amp 169 1 4 2 2 4 2 5 2 5 1 4 2 5 2
25. 2 3 3 1 4 9 6 2 1 4 1 1 9 2 1
26. 25 g g ISO10993 7 5 S 1 S 1 1 JIS T 0601 1 6 1 2 4 5 Hz V 6 A VA W 7 8 JIS T 0601 1 6 1
27. 7 19 20 58 13 JIS T 0601 1 21 23 24 45 1 4 2 MIS T 14971
28. _ HIS T 14971 1 4 2 3 4 2 4 4 MA 5 bB
29. 1 4 2 5 4 2 5 1 4 2 5 2 BB 16 169 MIS T 0601 1 44 7
30. 17 3 10 0310003 IS T 14971 UIS T 0601 1 6 8 1 4 2 3 4 2 4 5 2 MM HIS T 14971
31. 3 6 4
32. 3 1 3
33. 0 16 169 MIS T 14971 HIS T 14971 o 1 4 1 4 2 HIS T0601 1 7 ORE ROSS
34. LIS T 0601 1 21 23 24 25 45 1 4 2
35. 8 Eo ON 3 a 16 169 GMP Q MS 0330001 17 3 30 4 4 1 5 1 5 7
36. MTIS T 14971 1 2 5 4 2 5 1 4 2 5 2 8 L IST 0601 1 1 44 4 56 11 d MIS T 14971
37. 2 3 4
38. 1 1 a x 2 3 NN v NN 5 3
39. 2 19 6MPa 30 4 2 1 2 JIS T 0993 1 1 4 2 1 3
40. ASTM F882 84 6 2 7 ASTM F882 84 6 2 8 ASTM F882 84 6 2 10 ASTM F882 84 6 2 11 2 _ 0 1 16
41. 1 4 2 8 2 3 gt 4
42. 1 5 2 MTS T 14971 3 UIS T 14971 1 2 5 10
43. JIS T 0601 1 IST 0601 1 2 1 2 86 202 1 4 2 5 4 2 5 1 4 2 5 2 IST 0601 1 56 11 d MIS T 14971 IS T 14971
44. 4 4 1 JIS T 0601 1 JIS T 0601 1 2 ASTM F882 84 Reapproved 2002 Standard Performance and Safety Specification for Cryosurgical Medical Instruments ASTM F882 84 Reapproved 2002 Standard Performance and Safety Specification for Cryosurgical Medicai Instruments 3 1 1 closed cryotip 5 4 Monitoring Devices 6 Disclosure Labeiing and Documentation Requirements 7 2 Mechanical integrity 7 3 1 Cryogen Exhaust 7 3 2 Ambient Concentrations oFNitrous 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 13 Test Method for Determining the Accuracy of Temperature Monitors Cryotip and Tissue 5 4 2 4 2 1 JIS T0601 1 21 4 2 1 1
45. 6 7 3 60C 3 SC 4 2 8 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
46. 7 1 4 2 MIS T 14971 3 16 169 0 4
47. 2 1 3 4 2 5 1 1
48. 5 IS T 0601 1 2 A 2 86 201 6 0 JIS T 0601 1 2 1 NSP 2 36 202 7 UIS T 0601 1
49. 1 2 1 JIS T 0601 1 6 1 6 7 7 1 6 5 1 3 IS T 0601 1 6 6 1 JIS T 0601 1 56 3 a 5 1 4 1 2 3 5 1 5
50. 1 7 2 1 6 0216002 4 2 1 7 3 3 1 0331012 2 5 7 16 298 1 955 19 3 2 1
51. GMP QI IMS 0330001 17 3 30 4 4 10 s 16 169 1 5 1 4 lt 2
52. HIS T 14971 16 0331032 17 3 31 2 1 2 2
53. a 1 2 1 2 36 202 IS T 14971 5 IS T0601 1 25 42 3 52 56 57 59
54. 169 j 2
55. 1 5 JIS T 0601 1 6 15 2 3
56. 0302012 1 9 3 2 SE rE Hl Ho se 3 6 dc ig 3 5 1 4 5 1 4 1 19 2 1 1 4 9 1 9 2 5 I VD 1 1 7 2 1 6 0216002
57. 4 5 6 7
58. C ASTM F882 84 6 2 1 20 ASTM F882 84 6 2 3 ASTM F882 84 6 2 4 ASTM F882 84 6 2 5 AC ASTM F882 84 6 2 6 JIS T 0601 1 A1 6
59. IS 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 Es 3 5 3 6
60. Integrity 7 2 Mechanical Integrity 39 JIS B 8241 1 30
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