汎用冷凍手術ユニット承認基準の制定について (平成19年3月2日) (薬食
Contents
1.2. ml
3. JIS T 14971 0213001 15 2 13
4. gt UIS T 0601 1 1 45 1 4 2
5. 1 2 8 1 2 36 201 JIS T 0601 1 2 1
6. a ey NN 16 169
7. SI 56 3 a 57 kei ME 1 4 2 3 4 2 4 Ji T 0601 1 1
8. 14 96 2 14 1 19 2 1 kB 0216002
9. 4 2 Oo 5 1 1
10. 2 36 202 1 JIS T 0601 1 1 56 11 d JIS T 0601 1 2 1 2 36 202 JiS 1 0601 1 1 25 42 43 02 8
11. 6 1 16 169 JIS T 14971 1 1 4 2 7
12. 16 169 Ri 16 169 UIS T 14971 e a lt 2 VM 5
13. 1 4 2 5 4 2 5 1 JIS T 14971 1 4 2 3 4 2 4 1 4 2 5 4 2 5 1 4 2 5 2 JIS T 0601 1 1 d 11 1 4 2 5 4 2 5 1 4 2 5 2 8
14. UIS T 0601 1 1 6 EE 2 1 5
15. SAA 12
16. 16 169 JIS T 0601 1 1 T 5 14
17. 2 JIS T 0601 1 1 JIS T 0601 1 2 1 2 JIS T 0993 1 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 IS010993 7 Biological evaluation of medical devices Part7 Ethylene oxide sterilization residuals 3 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 IS010993 7 3
18. EE
19. 5 30 2
20. 1 4 2 UIS T 14971 oO 3 4
21. 1 SN Ri 16 169 UIS T 0601 1 1 44 7 oO a Ri 16 UIS T 0601 1
22. Ts T 0601 1 OE 1 6 3 11
23. Ri JIS T 0601 1 1 1 i 2
24. 2 17 3 31 0331012 gt 2 5 7 16 298 1 955 0 19 3 2 1 2 1 3
25. 16 169 UIS T 14971
26. 4 2 11 25g g IS0 10993 7 5 1 1 1 JIS T 0601 1 6 1 2 3 4 5 Hz
27. HIS T 0601 1 1 6 8 1 4 2 3 4 2 4 5 2 9 DTS T 0601 1 1 21 45 1 1 4 2
28. 3 4 5 6 7 3 EO 2 60 3 5 2 8
29. 1 2 3 5 1 5 2 1 2 17 3 10 0310003 3 on on on 4
30. a
31. 4 5 4 4 5C 4 2 8 2 JIS C 1602 4 2 9 JIS B 7505 4 2 10 ER
32. 16 169 1 5 2 5 16 169 GMP QMS 0330001 17 3 30 4 4 4
33. 5 19 6MPa 30 A a 2 1 2 22 JIS T 0993 1 1 2 1 3
34. 16 0331032 17 3 31 2 1 2
35. 7 2 36 202 JIS T 0601 1 1 7 19 20 58 13 2
36. 2 ED i UIS 1 0601 1 Es 1 6 3
37. 47 6 1 495 5 0 C ASTM 2 84 6 2 1 20 C MC ASTM F882 84 6 2 3 0 ASTM F882 84 6 2 4 ASTM P 84 6 2 5 ASTM F88
38. JIS B 8246 2 5 ASTM F882 84 7 3 1Cryogen Exhaust 2 5 1 ASTM F882 84 7 3 2Ambient Concentrations of Nitrous Oxide 4 2 5 2 4 2 5 3 ASTM F882 84 10 Test Method for Determining Ambient Concentration of Nitrous Oxide
39. JIS T 0601 1 23 2 1 4 ASTM F882 84 3 1 1closed a 2 2 ASTM F882 84 7 4Thermal Insulation 2 3 ASTM F882 84 5 4 1 2 2 4
40. 1 44 4 44 7 16 Ri 2 3
41. 4 2 6 60 2 7 60 gt 2 7 1 ASTM F882 84 11 Test Method for Determining Closed Cryotip Temperature Reproducibility 3 1 1000nL 1000mL 30C 2 2
42. 4 2 1 2 1 4 2 JIS T 0601 1 1 43 1 JIS T 14971
43. Ri UIS T 0601 1 1 JIS 7 2
44. 42 4 2 2 1 4 2 7 4 2 8 4 2 9 16 4 2 2 1 5 JIS T 0601 1 1 6 15 3
45. UIS T 14971 ey
46. 59 1 5 2 5 3 UIS T 14971 1 4 2 5 oO 10 E 1 4 2 7 4 2 8 4 2 9
47. V 6 A VA W 7 8 JIS T 0601 1 6 1 2 1 JIS T 0601 1 6 2 6 7 7 1 5 1 3 JIS T 0601 1 6 6 1 JIS T 0601 1 56 3 a 2 2 YR 5 1 4
48. 10 GMP QMS 0330001 17 3 30 4 4 0 1 5 16 169 GMP QMS 0330001 17 3 30 4 4 1 4 2 10
49. 1 1 28 32 2 13 1 1 54KB 3 2 60 12 ASTM 12 25ppm
50. 1 3 2 3 3 3 4 MGM 3 5 3 6 4 4 1 JIS T 0601 1 JIS T 0601 1 2 ASTM F882 84 Reapproved 2002
51. 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 gt gt on 2 3
52. 2 84 6 2 6 JIS T 0601 1 A1 6 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 8 1
53. O 19 3 2 0302012 35 145 14 1 19 2 1 14 9 19 2 5 IVD 1 17 2 16 0216002
54. Standard Performance and Safety Specification for Cryosurgical Medical Instruments ASTM F882 84 Reapproved 2002 Standard Performance and Safety Specification for Cryosurgical Medical Instruments 1 1 closed cryotip 4 Monitoring Devices Disclosure Labeling and Documentation Requirements 2 Mechanical Integrity 3 1 Cryogen Exhaust 3 2 Ambient Concentrations of Nitrous Oxide 4 Thermal Insulation 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 4 2 4 2 1 JIS T 0601 1 21 4 2 1 1 OMA OT CO ASTM F882 84 7 2 Mechanica
55. l Integrity gt 2 1 1 1 ASTM F882 1 9 Test Method for Mechanical Integrity 5 A o 3 5 5 2 JIS T 0601 1 25 43 1 44 4 45 1 1 2 ASTM F882 84 9 Test Method Mechanical Integrity 7 2 Mechanical Integrity 39 JIS B SM 1
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