目民科用冷凍手術ユニッ ト承認基準の制定について
Contents
1.2.
3.
4. 16 169
5. me NN 5 JJST 0601 1 2 1 2 36 201
6. JIST 14971 1 42 5 4 2 5 1 4 2 5 2
7. 16 169 JIS T 0601 1 1 44 7 16 169 JIS T 0601 1
8. _ gt 1 2 6
9. 5 5 2 1 3
10. JIS T 0601 1 1 6 1 1 6 2
11. 1 5 2 JIST 14971 JIS T 14971 3 ea 1 4 2 5
12. 5 A 42 82 JIS C 1602 4 2 9 JIS B 7505 4 2 10 4 2 11
13. JIS 2 16 169 JJS T 14971 JIS T 0601 1 1 7 1 4 2 JIS T 14971
14. 5 17 8 10 0310003 JIS T 14971 0216002 17 3 81 2 1 2
15. a GMP QMS 0830001 17 8 380 4 4 1 5 1 5 16 169
16. JIS 0601 1 1 6 3 1 1 2
17. ASTM F882 84 7 3 1 Cryoeen Exhaust 4 2 5 1 ASTM F882 84 7 3 2 Ambient Concentrations of Nitrous Oxide 4 2 5 2 Ce 4 2 5 3 ASTM F882 84 10 Test Method for WDM Ambient Concentration of Nitrous Oxide 1 1 28 32
18. gt JIS T 14971 JIS T 0601 1 1 6 3 5 JIST14971
19. 1 4 2 5 4 2 5 1 4 2 5 2 JIS T 0601 1 1 56 11 d JIST 14971 JIS T 14971
20. ASTM F882 84 7 2 Mechanical Integrity 4 2 1 1 1 ASTM F882 84 9 Test Method for Mechanical 1 Tntegrity 5 ein hisa etiologies _ 3 5 0 JIS T 0601 1 2 43 1 44 4 45 Sh 4 2 1 1 2 Me F882 84 9 Test Method for Mechanical Integrity 7 2 Mechanical Integrity 39 PR JIS B 8241 Rb A
21. 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 ASTM F882 84 6 2 11 1
22. ee 8 16 169 JIS T 0601 1 1 10 56 8 a 57 58 MS
23. i 5 30 6 ret 2 1 RW 5
24. 1 4 come 1 427 4 2 8 4 2 9 16 169
25. 3 1 2 I 4
26. v JIS T 14971 1 4 2 8
27. 19 6MPa 30 4 2 1 2 JIS T 0993 1 1 4 2 1 3 _ 2 JIS T0601 1 23
28. 16 169 16 169 4 JIS T 14971
29. JIST 14971 JIS T 0601 1 1 6 8 1 4 2 8 42 4 5 2 9 _ JIS T 14971
30. JIST 0601 1 2 1 6 2 36 202 JIS T 0601 1 1 7 7 19 20 58
31. 16 169 5 _ 2 JIS T 14971 0 St JIS T 14971 6 1 4 1
32. NN EEC 3 1 4 9 6 2 1 4 1 1 9 2 1 AA RS ei Ce 1 7 2 16 brie 0216002 4 PP 2
33. Re WW Aa A 60 4 2 7 1 ASTM F882 84 11 Test Method for Determining Closed Cryotip Temperature Reproducibility 3 1 1000mL 1000mL 30C2C 2 G
34. 16 169 1 0 1 5 1 4 17 3 10 0310008
35. A 5 1 4 1 2 3 5 1 5 lt n 5 2 1 2 17 3 10 0310003 3
36. 5 ea AS i NE 60C 3 Da 42 8 EC _Method for Determining the Accuracy of Temperature Monitors gel and Tissue 42 8 1 ASTM F882 84 13 Test Method for Determining the Accuracy of Temperature Monitors Cryotip and Tissue 3
37. v 1 4 2 8 4 2 4 YL JIS T 14971 JIS T 0601 1 1 42 NR 1 4 2 2 5
38. 1 5 2 5 16 169 9 v gt GMP QMS 0330001 17 8 80 4 4
39. JIS T0601 1 2 1 2 86 202 JIST 14971 JIS T 0601 1 1 25 42 48 52 56 57 59
40. 1 4 2 1 2 0 1 42 JIS T 0601 1 1 43 1 2 JIST 14971
41. JIS T 0601 1 1 21 23 24 25 45 4 2 JIST 0601 1 1 10 2 2 49 JIST 0601 1 2 1 2 86 202
42. EE 5 Es 1 1 2 JIST0601 1 1 I 1 2 JIST0993 1 1 JIS C 1602 JIS B 7505 JIS B 8241 JIS B 8246 ASTM F882 84 Standard Performance and Safety Specification for dl Medical Instruments _ ISO10993 7 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals JI
43. 3 ES 4 Hz V A VA W 7 i 5 1 2 1 JIS T 0601 1 6 1 6 7 7 1 5 1 3 JIS T 0601 1 6 6 1 JIS T 0601 1 56 3 a 2
44. 1 4 2 5 4 2 5 1 4 2 5 2 JIS T 14971 3 1 4 2 8 424
45. 1 5
46. 2Sug 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 5 25 15 17 6 30 0630001 1 II JMDN 13700000 19nnm 30 2C 100OrL
47. i 1 7 3 3 1 0331012 2 5 7 16 298 1 956 20 3 25 Hf 3 rt a 3 4 2
48. 4 1 JIS T0601 1 JIS T 0601 1 2 Be ASTM F882 84 AN 2002 Standard Performance and Safety Specification for Cryosureical Medical Instruments ASTM F882 84 Reapproved 2002 Standard Performance and Safety Specification for Cryosurgical Medical Instruments 3 1 1 closed cryotip 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 Concentration of Nitrous Oxide _11 Test Method for Determining Closed Cryotip 1emperature Reproducibility 12 Tractive Force Test Method 13 Test Method for Determining the Accuracy of Temperature Monitors Cryotip and Tissue 4 2 4 2 1 JIS T0601 1 21 4 2 1 1
49. 1 44 4 44 7 16 169 US T 0601 1 1 44 4 44 7 2 3
50. 7 GMPQMS 0330001 17 8 30 4 4 1 4 2 10 16 169 8
51. JIS T 0601 1 1 56 11 d JIST 14971 1 4 2 5 42 5 1 4 2 5 2 RL 8
52. 1 3 JIS T 0601 1 1 21 23 24 45 1 42 JIST 14971 2
53. 4 2 1 4 ASTM F882 84 3 1 1 closed cryotip 4 2 1 4 1 OV a 10 0 35 0mm 2 0 4 0mm 2 0 20 0mm 10 0 35 0mm 1 5 3 0mmm 2 0 20 0mm 2 0 5 0mm _ 10 0 40 0mm 01 5 3 5mm 2 0 30 0mm 1 5 4 0mm TT TT TT TT TT mre ere TT TT TT 10 0 40 0mm LO 3 5mm 1 5 4 0mm 10 0 35 0mm 2 0 4 0mm 2 0 20 0mm _ 20 0 35 0mm b 0 6 1 5mm 10 0 35 0mm 0 l 0 2 5mm 10 0 35 0mm b 01 0 2 5mm 2 0 20 0mm a 20 0 60 0mm gpl 5 4 0mm 2 0 20
54. 2 1 4 2 2 4 2 5 4 2 5 1 4 2 5 2 FC 1 5 JIS T 0601 1 1 6
55. 42 JIS T 0601 1 1 7 JIST 14971 0213001 15 2 13
56. 4 47 6 1 493 la 0C 1 ASTM F882 84 20C EE ASTM F882 84 6 2 3 A ASTM F882 84 6 2 4 ASTM F882 84 6 2 3 AC
57. 1 0 1 42 7 4 2 8 4 2 9 2 P
58. 0mm 4 0 12 0mm 20 0 60 0mm 01 5 4 0rmm 4 0 12 0mm 25 0 45 0mm 091 0 2 0mm 2 0 30 0mm 15 0 60 0mm pl 0 3 0mm 2 0 20 0mm 1 5 4 0mm 20 0 45 0mm b 1 0 4 0mm 2 0 20 0mm 10 0 40 0mm pl 0 3 0mm 2 0 20 0mm 2 0 8 0mm 42 2 ASTM F882 84 7 4 Thermal Insulation 42 3 ASTM F882 84 5 4 1 2 4 2 4 JIS B 8246 4 2 5
59. 2 13 142 lt 17 0 30cm 5 90cm 20 1S hr a 2 60 12 i IRON NG CE RE ROME CE 2 ls 60
60. 6Og 1 2 60g OO ON SE A RE eee 4 ee 6 OS 45 EN CO 45 5 5 1 5 1 1 JIS T 0601 1 6 G 2 2
61. S T 0601 1 JIS T 0601 1 2 JIS T 0993 1 a 1602 JISB 7505 JIS B 8241 JIS B 8246 ASTM F882 84 ISO10993 7 3 1 1 3 2 3 3 3 4 3 5 3 6
62. ht eS 0325013 20 3 25 H MG EN DN 1 9 2 1 0 SU 1 4 9 1 9 2 5 DO VD _ 1 7 2 1 6 0216002
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