眼科用冷凍手術ユニット承認基準の制定について
Contents
1.2. 16 169 1 5 1 4 17 10
3. JIST 14971 JIST0601 1 2 1 2 36 202 JST 14971 1 2
4. 30 5 3 19 6MPa 30 4 2 1 2
5. I 1 428 2 3 1 4
6. 1 42 8 424 4 5
7. 427 4 2 8 42 9 3 3 4
8. JTS T 0601 1 2 1 JIS 7
9. 16 169 GMP QMS 0380001 17 8 80 4 4 1 0
10. JTS T 0601 1 1 25 42 43 52 56 57 59 1 5 2 JIST 14971 3
11. 4 5
12. 1 16 169 1 JTS T 14971
13. ASTM F882 84 5 4 1 2 4 2 4 4 2 5 JIS B 8246 Cryogen Exhaust 4 2 5 1 ASTM F882 84 7 3 2 Ambient Concentrations of Nitrous Oxide
14. 5 16 169 JJS T 14971 JUST 14971 6
15. wn 6 16 169
16. ASTM F882 84 13 Test Method for Determining fhe 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 3
17. 4 5 6
18. JIST 14971 1 42 5 4 2 5 1 42 5 2 3 JST 14971
19. JTS T 0601 1 1 6 5 17 3 10 0310008
20. 3 5 6 7 3 60C 3 2 42 8
21. JST 0601 1 1 21 23 24 25 45 0 1 42 JISPT0601 1 1 10 2 2 49 JHST 0601 1 2 1 2 86 202
22. vy 3 vy 4 TS 14971
23. 1 4 25 42 5 1 42 5 2 JTS T 0601 1 1 56 11 JIS T 14971 H 1 F
24. vs 5 JIST 0601 1 2 1 2 36 201 6
25. 1 42 JIS T 14971 3
26. 16 169 4 16 169 JIS T 14971
27. 16 169 JIS T 0601 1 1 10 56 8 a 57 58 1 4 2 3 424 JST 14971 5 JTS T 0601 1
28. 2 5 7 16 298 1 956 20 3 25 1 Ni 2 1 3
29. JIS T 14971 H 1 0213001 15 2 18 1 42 1 2 1 4 2 JTS T 0601 1 1 48 1 2 8 4 E
30. 1 1 41 42 JIS T 0601 1 1 7 Ba
31. 42 6 60C _427 60C 4 2 7 1 ASTM F882 84 11 Test Method for Determining Closed Cryotip Temperature Reproducibility 3 1 1000mL 1000mL 30C 2
32. 1 4 4 2 1 3 E IS T 0993 1 4 E 1 JIS T0601 1 23
33. 4 2 1 4 cryotip ASTM F882 84 3 1 1 closed 4 2 1 4 1 _ 1 a 10 0 35 0mm s i b 2 0 4 0mm NT e 2 0 20 0mm a 10 0 35 0mm b 1 5 3 0mm e 2 0 20 0mm d 2 0 5 0mm 1 3 a 10 0 40 0mm he 1 b 1 5 3 5mm Bf 5 ci 2 0 30 0mm 9 1 d 1 5 4 0mm 1 a 10 0 40 0mm b pl 5 3 5mm bf f d 1 5 4 0mm a 10 0 35 0mm
34. I VD 1 3 1 7 2 1 6 0216002 p 2 2 3
35. IS T 0601 1 6 1 G 5 Hz V 6 A VA W 8 JHS T 0601 1 6 1 5 1 2 1 JS T 0601 1 6 1 6 7 7 1 3 13 3
36. 16 169 1 4 2 2 42 5 42 5 1 42 5 2 3 1 5 JTS T 0601 1
37. ASTM F882 84 7 3 1 4 2 5 2 4 2 5 3 ASTM F882 84 10 Test Method for Determining Ambient Concentration of Nitrous Oxide 1 1 2 13 28 32
38. JTS T 0601 1 1 6 3 5 JST 14971 JIS T 0601 1 1 6 8 1 1
39. 17 3 10 0310003 E FE 3 4 47 6 1 49 5 0 62 1 20
40. GIMP QMS 0880001 7 8 30 4 4 1 5 1 5 7 16
41. JST 14971 1 42 5 4 2 5 1 42 5 2 6 JIS T 0601 1 1 44 4 56 11 9
42. 0 7 8 1 2 JTST 14971
43. 4 2 8 2 JS C 1602 4 2 9 JIS B 7505 4 2 10 4 2 11 SO10993 7 25pg g 4 2 12 4 2 1 4 1
44. ASTM F882 84 ASTM F882 84 6 2 3 3 FN ASTM F882 84 6 2 4 6 2 5 H ASTM F882 84 AC ASTM F882 84 6 2 6 JIST0601 1 A1 6
45. 1 6 1 5 2 3
46. 0810008 JES T 14971 vs BB JIS T 0601 1 1 6 8 1 42 8 42 4 5 2 9 ST 14971
47. JST0601 12 1 2 36 202 7 JTIS T 0601 1 1 7 19 20 58 1 3
48. H ASTM F882 84 6 2 7 ASTM F882 84 6 2 8 E ASTM F882 84 6 2 10 ASTM F882 84 6 2 11 2
49. JIST 14971 1 42 5 42 5 1 42 5 2 8
50. 3 B 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 15 25 2 1 17 6 30 063000 1 I JMDN 13700000 2 O 19mrmn 8 5mmR 30 2 C 1000mL 60g
51. 1 42 1 4 2 2 1 4 2
52. i 2 sg 3
53. 4 2 5 _ 1 1 2 JIST0601 1 1 JIS T 0601 1 2 1 2 JIST0993 1 1 JIS C 1602
54. JIS T 14971 1 6 4 0216002 17 3 81 2 1 2 2 4
55. 4 44 7 2 3 B
56. 3 5 3 6 f 4 4 1 JIS T 0601 1 JIS T 0601 1 2 ASTM F882 84 Reapproved 2002 Standard Performance and Safety Specificafion for Cryosurgical Medical instraments 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 Requirements 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 Concentr
57. 1 4 9 6 2 1 4 1 1 9 2 1 1 7 2 1 6 0216002 4 2 1 7 3 3 1 0331012
58. IS T 0601 1 6 6 1 JIS T 0601 1 56 3 a 3 1 4 1 5 1 5 4 d 5 2 1
59. L b p2 0 4 0mm 6 bf c 2 0 20 0mm 4 2 2 3 1 a 200 35 0mm b qp0 8 I1 5mm 4 1 s a 10 0 35 0mm b pl 0 2 5mm 4 a 10 0 35 0mm b 01 0 2 5mm Nf e 2 0 20 0mm Ts a a 20 0 60 0mm 6 bp1 5 4 0mm c 2 0 20 0mm 9 d 4 0 12 0mm 3 _ a 20 0 60 0mm d b pl 5 4 0mm bt d 4 0 12 0mm 6 1 a 25 0 45 0mm c 2 0 30 0mm 7 sa a 15 0 60 0mm b ql 0 3 0mm BT 1 c 2 0 20 0mm d 1 5 4 0mm a 20 0 45 0mm b e1 0 4 0mm b1 c 2 0 20 0mm 7 3 s a 10 0 40 0mm b 1 0 3 0mm 1 T ce 2 0 20 0mm d 2 0 8 0mm f F ASTM F882 84 7 4 Thermal Insulation 42 3
60. 142 17 0 30cm 90cm 9ocm 3 2 60 12 ASTM 12 25ppm
61. 169 GMP QMS 0880001 7 8 30 4 4 1 4 2 10 8 16 169 1 5 2 9
62. 1 2 60g 2 1000mL 30 2C O 3 5 6 45 45 5 5 1 5 1 1
63. 5 5 JIS T 0601 1 25 43 1 44 4 45 4 2 1 1 2 ASTM F882 84 9 Test Method for Mechanical integrity 7 2 Mechanical Integriy 39 JIS B 8241 1 5
64. 16 169 JJS T 0601 1 1 44 7 16 169 JIS T 0601 1 1 44 4 44 7 Y 16 169 JTS T 0601 1 1
65. JISB 7505 JSB8241 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 JIS T 0601 1 JIS T 0601 1 2 JJS T 0993 1 JIS C 1602 JIS B 7505 JS B 8241 JIS B 8246 ASTM F882 84 ISO10993 7 3 1 3 2 3 3 3 4
66. JIST 14971 1 4 2 5 1 0 E 2 1 427 42 8 42 9
67. TS T 0601 1 1 21 28 24 45 1 42 JST 14971 2 9
68. 20 33 40 4 1 20 3 25 0325013 EE 0325013 2 0 3 2 5 3 5 1 4 5 1 4 1 19 2 1 1 4 9 1 9 2 5
69. ation of Nitrous Oxide 11 Test Method for Determining Closed Cryotip Temperature Reproducibihty 12 Tractive Force Test Method 13 Test Method for Determining the Accuracy of Temperature Monitors Cryotip and Tissue 4 2 4 2 1 JHS T0601 1 21 42 1 1 ASTM F882 84 7 2 Mechanical Integrity 4 2 1 1 1 ASTM F882 84 9 Test Method for Mechanical Imtegrity 5 3
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