薬食発第 03020ー2 号 平成ー 9年 3月 2日
Contents
1. 30 22. 3 4 5
3. 4 2 5 1 1
4. 7 1 8 16 169 GMPQ IMS
5. 3 2 s a JTS T 0601 1 1
6. 0 16 169 1 4 2 2 4 2 5 4 2 5 1 4 2 5 2 1 5 A 6 15
7. 2 JIST0601 1 1 JIS T 0601 1 2 1 2 JIST60993 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 ISO10993 7 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals 3 JIS T 0601 1 JST 0601 1 2 JIS T 0993 1 JIS C 1602 JIS B 7505 JIS B 8241 JIS B 8246 ASTM F882 84 ISO10993 7
8. 3 9 j 17 3 10 0810008 TS T 14971 UIST 0601 1
9. 3 1 169 T 0601 1 1 44 4 44 7
10. mC 16 169 HTS T 14971 16 169 IS T 14971 Ako ST 14971 6
11. 19 6MPa 30 4 2 1 2 IS T 0993 1 1 4 2 1 3
12. 5 MIS T 14971 1 4 2 5 4 2 5 1 4 2 5 2 DIS T 0601 1 44 4 56 11 d 6
13. 1 2 _ 3 4 LO
14. 2 7 _ 3 5 1 4 2 UIS T 0601 1 IST 0601 1 2
15. 3 EN HIS T 14971 1 4 2 5 4 2 5 1 4 2 5 2 8
16. 5C 4 2 8 2 JIS C 1602 4 2 9 JIS B 7505 4 2 10 4 2 11 25 gg 1SO10993 7 5
17. 6 8 _ 1 5 17 3 10 A 0310003 MIS T 14971 a 2 0
18. 0 3 tp a 16 169 4 5
19. 1 4 1 4 2 5 DTST 06011 NN 3
20. 11 1 DTIS T 14971 4 2 5 4 2 7 4 2 8 4 2 9 2 es
21. ASTM F882 84 6 2 4 ASTM F882 84 6 2 3 AC ASTM F882 84 6 2 6 JIST 0601 1 A1 6 ASTM F882 84 6 2 7 RE ASTM F882 84 6 2 8
22. 2
23. 3 4 i v 3 5 vi 2 7IS T0801 1 2
24. 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 ASTM F882 84 3 4 1 2 4
25. 16 169 GMP GQ MS 0880001 17 8 80 4 4 10 Y 16 169 1 5 1 4
26. 2 6 3 1 4 9 6 2 1 4 1 1 9 2 1 1 7 2 1 6
27. 3 2 60 12 ASTM 12 25ppm 2 4 2 6 60 C 42 7 60
28. MIS T 14971 UIS T 0601 1 1 6 3 11 _ 2 7
29. 16 169 44 4 44 7 IS T 0601 1 5 6
30. 2 6 7 NN 8
31. 7 h JIS T 14971 0218001 15 2 18 4 2 1 2 1 IST 0601 1 1
32. 86 202 ST 14971 IST 0601 1 5 2 43 52 56 57 Vt DIS T 14971 3 10 RE
33. a 4 3 5 i HTIS T 14971 1S T 0601 1 1 6 3
34. WV TS T 14971 16 169 ek JIS 1 IST 0601 1 1 7 IS T 14971
35. ASTM F882 84 6 2 10 ASTM F882 84 6 2 11 i 1 2
36. 3 4 16 Rua NR 169 JIS T 0601 1 10 56 3 a 57
37. 3 1 AE 3 2 3 3 3 4 3 3 5 3 6 4 4 1 JIS T 0601 1 JIS T 0601 1 2 ASTM F882 84 Reapp
38. 48 1 2 5 JIS FT 14971 1 4 2 5 4 2 5 1 4 2 5 2 IS T 14971 1 4 2 8 4 2 4 4
39. s1 3 IS T0601 1 6 6 1 MES JST0601 1 363a s 1 4 1 3 5 1 5 5 2
40. 1 0 52 17 3 10 0310003 6 2 3 4 47 6 1 495 5 0 C NM2 ASTM F882 84 6 20 ASTM F882 84 6 2 3
41. 1 2 36 202 1 4 2 5 4 2 5 1 4 2 5 2 ST 0601 1 56 11 d DIST 14971 IS T 14971 UIST 0601 1 2 2
42. 1 1 2 2 me oe 1 4 2 8
43. 0216002 4 2 NH 1 7 3 3 1 0931012 2 5 7 16 298 2 1 955 19 3 2 1 2 1 3
44. 4 2 0331032 17 3 31 2 1 2 2
45. 1 8 4 2 10 0 16 169 9 1 5 2 5 9 BK A
46. 0302012 1 9 3 2 _ 3 5 1 4 5 1 4 1 19 2 1 1 4 9 1 9 2 5 1 VD ul 1 17 2 1 6 0216002
47. 7 3 60 3 5 C 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 3
48. 86 201 6 RNN oS MR Eg Po Z JIS T 0601 1 2 1 2 36 202 7 1S T 0601 1 7 19 20 58 amp 1 3
49. 0380001 17 3 30 4 4 5 1 5 0 16 169 GMP G IMS 0380001 77 8 80 4 4
50. JIS T 0601 1 21 23 24 45 1 4 2 MIS TT 14971 2
51. 1 4 GO 2 1 4 2 7 4 2 8 4 2 9 3
52. 4 2 7 1 ASTM F882 84 11 Test Method for Determining Closed 09 Temperature Reproducibility 3 1 1000mL 1000mL 30 2 4 2 3 4 5 3 6
53. 1 6 8 1 4 2 8 4 2 4 5 2 MJIS 14971 IST 0601 1 21 23 24 25 B
54. 58 g 0 1 4 2 8 4 2 4 ST 14971 9 5 fb JIS T 0601 1 1 42 1 4 2 2
55. 9 16 169 MIS T 0601 1 47 1 16 ON L 2
56. 2 4 IS 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 4 2 5 3 ASTM F8
57. 5 1 5 1 1 IS T 0601 1 6 1 2 G 4 5 Hz V 6 AVA W _ 7 RS OO 5 1 2 1 JIS T 0601 1 6 1 6 7 7 1
58. 82 84 10 Test Method for Determining Ambient Concentration of Nitrous Oxide 3 1 1 28 32 2 13 1 142 17 0 30am 0on gocm a
59. roved 2002 Standard Performance and Safety Specification for Cryosurgical Medical Instruments 1 ASTIM F882 84 Reapproved 2002 Standard Performance and Safety Specification for Cryosurgical Medical Instruments 3 1 1 closed cryotp 5 4 Monitoring Devices 6 Disclosure Labeling 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 Cryotp Temperature Reproducibility 13 Test Method for Determining the NACS of RIE Monitors Cryotip and Tissue 42 4 2 1 JIS T0601 1 21 4 2 1 1 ASTM F882 84 7 2 Mechanical Integrit
60. y 42 1 11 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 Integrity 7 2 Mechanical Integrity 39 JIS B 8241 1
Download Pdf Manuals
Related Search