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1. E
2. 1 4 2 8 42 4 8 4
3. 1 4 2 8 2 6 3 4
4. ws JST 14971 JEST 0601 1 2 1 2 3
5. 5 JJST0601 1 2 1 2 2 86 201 6
6. JIST 14971 0213001 15 2 13 1 4 2 1 2 1 4 2 JIS T 0601 1 1 43 1 2
7. 16 169 JIS T 0601 1 1 447 16 169 IS T 0601 1 1 444 44 7
8. TS T 0601 1 1 6 1 5 Pe 17 8 10 0310003 JIS T 14971
9. 30 2 5 19 6MPa
10. 3 6 169 6
11. 2
12. JIS T 0601 1 25 43 1 44 4 45 1 4 2 1 1 2 A ASTM F882 84 9 Test Method for Mechanical Integrity 7 2 Mechanical 0 3 39 JIS B 8241
13. 5 2 1 2 17 3 10 0310003 3 4 47 6 1 495 5 0C
14. 16 169 GMP QMS 0880001 7 3 30 4 4 1 5 1 5 7
15. ASTM F882 84 3 1 1 closed cryotip 4 2 1 4 1 1 a 10 0 35 0mm s b e2 0 4 0mm i c 2 0 20 0mm 2 es a a 10 0 35 0mm RN b e1 5 3 0mm 0 ci 2 0 20 0mm O d 2 0 3 0mm 1 3 a 10 0 40 0mm 1 b pl 5 3 5mm Zs ce 2 0 30 0mm d 1 d 15 4 0mm a 10 0 40 0mm_ b 1 5 3 5mm pT UA d 1 5 4 0mm 2 a 10 0 35 0mm b p2 0 4 0mm ci 2 0 20 0mm
16. 16 169 JJS T 0601 1 1 444 44 7 2 3
17. 1 2 3 6 SD 5
18. 2 5 7 16 298 1 956 F 20 3 25 Et NN Y 2 1 3 4
19. 5C 4 2 8 2 JIS C 1602 4 2 9 JIS B 7505 4 2 10 4 2 11
20. JIS T 0601 1 1 6 3 5 JIS T 14971 TS T 0601 1 1 6 3 1 1
21. 30 2C 1000mL GOg 1 2 60g O 2 1000mL 302 0 3 5 6 45 45
22. ot
23. 1 44 4 56 11 9 JIST 14971 1 2 5 425 1 2 5 2 8
24. 1 6 0216002 17 3 81 2 1 2 2
25. 7 1 5 1 3 JJS T 0601 1 6 6 1 JIS T 0601 1 56 3 a 2 1 4 1 3 5 1 5
26. 7 i 8 1 2 JI8T 14971
27. 3 Oxide 1 ASTM F882 84 7 3 2 Amb jent Concentrations of Nitrous Oxide ASTM F882 84 10 Test Method for Determining Ambient Concentration of Nitrous 1 28 32 2 13
28. 4 JIST 14971 IP 1 42 5 42 5 1 42 5 2 B 3 JIS T 14971
29. 1 a 3 14217 0 30cm Ocm 90cm F BB 3 2 60 12
30. 4 16 169 JIS T 14971 5
31. 1 9 21 23 24 45 1 4 2 JIST 14971 2
32. 16 169 NR JIS T 0601 1 1 10 56 3 57 a 58 1 423 42 4 JIS T 14971 5 JTS T 0601 1 1 42
33. 1 4 2 2 42 5 42 5 1 4 2 5 2 3 1 5 JIS T 060 1 6 ed 2 3
34. 7 1 42 i JIS T 14971
35. 1 5 2 5 9 16 169 GMP QMS
36. 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 0630001 1 II JMDN 13700000
37. JIST 14971 JIS T 0601 1 1 21 23 24 25 45 1 4 2 JIST0601 1 1
38. 42 8 42 9 2 3 4 JTS T 14971
39. 1 E E 1 4 E 1 9 2 1 0216002 H 1 7 4 2 1 7 3 3 1 0331012
40. 16 169 GMP QMS 0880001 17 3 30 4 4 1 4 2 10 8 16 169
41. JIS T 14971 JIS T 0601 1 2 1 JIS
42. i l ii N 3 5 1 4 5 1 9 2 1 9 1 9 2 5 ve teint 0325013 2 0 3 2 5 a 1 4 1 1 4 I YD
43. 3 a 20 0 35 0mm b 0 8 1 5mm 41 a a 10 0 35 0mm T b pl 0 2 5mm NR 9 A a 10 0 35 0mm rd b w1 0 2 5mm 0 c 2 0 20 0mm 5 1 a a 20 0 60 0mm co b pl1 5 4 0mm 0 c 2 0 20 0mm d d 4 0 12 0mm 2 1 f a 20 0 60 0mm 3 b 1 5 4 0mm b1 d 4 0 12 0mm 6 1 i a 25 0 45 0mm b e1 0 2 0mm 6 WW c 2 0 30 0mm 7 1 a a 15 0 60 0mm b 1 0 3 0mm bB1 1 c 2 0 20 0mm d 1 5 4 0mm RB 1 7 a 20 0 45 0mm 0 CR bf ci 2 0 20 0mm 7G _ 1 a 0 1 a 10 0 40 0mm bf ce b w1 0 3 0mm T ec 2 0 20 0mm 4 d 2 0 8 0mm Tf 4 2 2 8 i ASTM F882 84 7 4 Thermal 4 2 3 4 2 4 4 2 5 Insulat
44. 10 2 2 49 JIST 06011 2 1 2 86 202 0 1 4 25 4 2 5 1 42 5 2 8 JTS T 0601 1 1 56 11 d JIST 14971
45. 3 4 5 6
46. 5 1 3 1 5 1 1 JST 0601 1 6 1 2 3 4 5 Hz V A VA W 7 8 JIS T 0601 1 6 1 3 1 2 JS T 0601 1 6 1 6 7
47. 1 2 Eo OE NNa gf F 3 4 2 16 9 6 2 5 1 4 1 F HH
48. 3 JST 14971 1 4 2 5 1 0 1 42 7
49. JISTT 0601 1 2 1 2 36 202 7 TS T 0601 1 1 4 7 19 1 20 58 1 3 IS T 0601 1
50. 60C 3 5 2 42 8 ASTM F882 84 13 Test Method for Determining the Accuracy of Temperafure Monitors Cryotip and Tissue 42 8 1 ASTM F882 84 13 Test Method for Determining the Accuracy of Temperature Monitors Cryotip and Tissue 3 3
51. 2 5 1 1 2 JIST0601 1 1 JIST 0601 1 2 1 2 JIS T0993 1 1 JISC 1602 JIS B 7305
52. 6 169 JIS T 14971 JIS T 14971 1 41 42 JIS T 0601 1 1 7 i L
53. 3 4 3
54. ASTM F882 84 6 2 7 ASTM F882 84 6 2 8 ASTM F882 84 6 2 10 ASTM F882 84 6 2 11
55. 1 1000mL 1000mL 30C 2C 3 4 5 6 7 3
56. 2 1 16 169
57. 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 JIS T 0601 1 JIST 0601 1 2 JIS T 0993 1 JES C 1602 JIS B 7505 JIS B 8241 JIS B 8246 ASTM F882 84 ISO10993 7 3 1 3 2 3 3 3 4
58. 1 42 2 1 4 1 42 7 4 2 8 4 2 9
59. 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 JIST 0601 1 A1 6
60. 1 5 2 16 169
61. 30 4 2 1 2 IS T0993 1 1 4 2 1 3 JIS T0601 1 23 4 2 1 4
62. 5 JIST 14971 1 1 4 2 5 4 2 5 1 4 2 5 2 6 JIS T 0601 1
63. ASTM 12 25ppm 42 6 60 4 2 7 60C 4 2 7 1 ASTM F882 84 11 Test Method for Determining Closed Cryotip Temperature Reproducibiity 3
64. 0880001 7 8 80 4 4 1 0 16 169 5 1 5 1 4 17
65. amp 3 5 3 6 4 4 1 JS 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 IMedical Instruments 3 1 1 closed cryotip 3 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 Con
66. 8 10 0810008 JIS T 14971 JTS T 0601 1 1 6 8 1 4 2 3 42 4 5 2 9
67. 6 202 JIS T 14971 2 JTS T 0601 1 1 25 42 43 52 56 57 59 0 1 5 2 JTS T 14971
68. centration 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 42 1 IS T0601 1 21 42 1 1 B ASTM F882 84 7 2 Mechanical Integrity 4 2 1 1 1 ASTM F882 84 9 Test Method for Mechanical mtegrity 5 3 5 5
69. ion A STM F882 84 5 4 1 2 Cryogen Exhaust 4 2 5 1 8 4 2 5 2 j 4 2 5 3 IS B 8246 ASTM F882 84 7 3 1

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