眼科用冷凍手術ユニット承認基準の制定について [PDFファイル／2.23MB]
Contents
1. 16 169 GMP QMS2. 16 169 a a GMP Q
3. 16 169 rm 4 2 2 4 2 5 4 2 5 1 4 2 5 2 1 5
4. 1 4 2 8 Ad
5. 1 2 GC NN JJS T 14971
6. 16 169 JIS T 0601 1 1 10 56 3 a 57 58 1 4 2 3 424 _ JHS FT 14971 JIS T 0601 1 1 20 42 Ms 1 4 2 2 1 4 2 7 4 2 8 PO 4 2 9 _2
7. 2 AR AE DE 1
8. a 2
9. 5 1 4 3 RPM ie We
10. ASTM F882 84 6 2 7 ASTM F882 84 6 2 8 3 ae 4 ee aw ASTM F882 84 6 2 10 _ ASTM F882 84 6 2 11 1
11. 4 5 6
12. RG ol _JIST 0601 1 2 1 2 36 201 RM JIS T 0601 1 2 1 2 36 202
13. 3 2 16 169 JIS T 14971 JIS T 0601 1 1 7 1 4 2 JIS T 14971
14. 3 gt 22 2 3
15. 8 s 1 5
16. PT 2 a 3 1 4 9 6 2 1 4 1 1 9 2 1 1 7 2 1 6 0216002 OR
17. 1 4 2 5 44 4 56 11 d JIST 14971 4 2 5 2 8
18. ASTM F882 84 3 cloxe cryotip 4 2 1 4 1 PO NN a 10 0 35 0mm ey i 2 0 4 0mm SbT 2 0 20 0mm i a 10 0 35 0mm 1 a b 1 5 3 0mm a c 2 0 20 0mm d 2 0 5 0mm 3 1 3 a 10 0 40 0mm Mi d b ql1 5 3 5mm b1 6 c 2 0 30 0mm dT d 15 40mm a 10 0 40 0mm DO0159 3 9mm d 1 S 4 0mm a 10 0 35 0mm b 02 0 4 0mm 2 0 20 0mm 20 0 35 0mm b 0 8 1 5mm 10 0 35 0mm b 1 0 2 5mm 10 0 35 0mmm b ql1 0 2 5mm 2 0 20 0mm a 20 0 60 0mm b o1 S 4 0mm lt 2 0 20 0mm A d 4 0 12 0mm a 20 0 60 0mm b 1 5 4 0mm d 4 0 12 0mm 25 0 45 0mm _b 1 0 2 0mm 2 0 30 0mm 15 0 60 0mm pl 0 3 0mm 2 0 20 0mm 1 5 4 0
19. 52 56 57 59 8 1 5 2 JIST 14971 JIST 14971 1 42 5 1 0 1 42 7
20. 0C ASTM F882 84 6 2 1 20C _ 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 JIS T 0601 1 A1 6
21. JTS T 0601 1 1 _ 21 23 24 25 45 1 42 JIST0601 1 1 9 10 2 2 49 JIST 0601 1 2 1 Mi 2 36 202 1 4 2 5 4 2 5 1 4 2 5 2
22. b JIS T 0601 1 1 6 3 JIS T 14971 5 JIS T 0601 1 1 6 3 1 1
23. H 2 C Ne a Ht JIST 14971 0213001 15 2 13 1 4 2 1 2 1 4 2 JIS T 0601 1 43 1 JIST 14971 1 4 2 5 4 2 5 1 4 2 5 2 3
24. WN R JIS T 14971 JIS T0601 1 2 NE 2 36 202 JST 14971 JIS T 0601 1 1 25 42 43
25. 16 169 1 5 1 4 17 3 10 0310003 ST 14971
26. ASTM F882 84 7 3 1 _Cryogen Exhaust 4 2 5 1 ER ASTM F882 84 7 3 2 Ambient 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 1 1 28 32 2 13 NE 1
27. 1 2 3 5 1 5 A 5 2 1 4 8 47 6 1 495
28. 4 2 5 2 1 1 2 JIS T 0601 1 1 Pe 2 a JIS T0993 1 1 JIS C 1602 JIS B 7505 JIS B 8241 JIS B 8246 ASTM F882 84 Stan
29. 4 EE 2 neg hn 1 7 3 3 361012 RS a 2 5 7 16 298 1 956 20 3 25 i 7 2 1 CE 8 3
30. _ gt 4 8 2
31. 4 2 6 60 8 GN 4 2 7 wi ER en MP 4 DF 4 2 7 1 ASTM F882 84 11 Test Method for Determining Closed Cryotip Temperature _ Reproducibility 3 1 1000mL 1000mL 30 2 2 i
32. _ 5
33. hc 5 Ne Ph 0 re 5 a 4 2 8 2 ei 4 2 9 JIS B 7505 earw oNWE 4 2 10 4 2 11 25uge ISO10993 7 4 2 12 4 2 1 4 1
34. 142 17 0 3ogn 90cm 90mn _ PR ph 2 60 12 OO ASTM 12 25ppm
35. 3 PR D Ot AA NPC 30 ek EE _
36. 2 2 1 U A ED CGIOIENE ZY 7 I 2 gt EX 0 26T LSIP 1 04 gt i NE 69T 91 2 O 4WN2 2 7
37. ma AAM Taare Re rT 42 5 1 42 5 2 TS T 0601 1 1 1 4 2 5 4 2 5 1 JIST 14971 1 4 2 3 4 2 4 8 KO J JIS T 14971
38. 4 2 8 42 9 2 0 DN _ JIS T 14971
39. 3 EE 4 _ i i RO 0 60C 3 5 4 2 8 2 oa epee ogi Sgr ddo Method for Determining the SC of Temperature Monitors Dohp and Tissue 4281 AS
40. 19 6MPa 30 4 2 1 2 m JIST 0993 1 13 RO OR JIS TO601 1 23 4 2 1 4
41. 1 44 4 44 7 _ 2 gt
42. tam ea e JST 14971 i 2 ee 2 3 2 4
43. 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 i 4 _ 2 i es Mori 17 6 30 0630001 a 1 H JMDN 13700000 2 O 19mmm 30 2 C 1000mL 6Og 2 60g O 1000mL G02C
44. 8 JIS T 0601 1 6 1 312 1 JIS T 0601 1 6 1 67 Ns 7 1 5 1 3 IS T 0601 1 6 6 JIS T 0601 1 563 a 2 NM 5 1 4
45. JIS T 06011 1 2 56 11 9 ST 14971 _ 3 Me AA 3 8
46. JIS T 0601 1 RG 1 NN 7 19 20 58 4 I EN 1 3 JIS T 0601 1 1 PA 21 23 24 45 1 42 m w rm
47. 0880001 17 3 30 4 4 1 4 2 10 16 169 1 5 2 5 16 169 GMPZQMS 0330001 17 3 30 4 4 1 0
48. O 3 PP a teen 2 Gm TRA TFET a 6 1 5 45 5 5 1 5 1 1 IST 0601 1 6 _ 3 4 3 Hz V 6 A VA W 7
49. 8 JIS T 0601 1 1 _6 8 1 4 2 8 424 HH 5 2 9 JIS T 14971 a
50. a JIS T 0601 1 1 6 NNN IS T 0601 1 1 _ 1 5 17 3 10
51. 16 169 JIS T 0601 1 1 44 7 16 169 JIS T 0601 1 1 44 4 44 7 16 169 JIS T 0601 1
52. JIS _
53. 0325013 20 3 25 rm 9 9 1 4 5 1 4 1 19 2 1 1 4 9 1 9 2 5 _ 1 VD 1 7 2 1 6 0216002 Mo
54. 0310003 JIST 14971 1 6 0216002 17 3 81 2 _ 1 2
55. JIS T0601 1 21 4 2 1 1 I ASTM F882 84 7 2 Mechanical Integrity 4 2 1 1 1 ASTM F882 84 9 Test Method for Mechanical Integrity 5 3 3 5 ON JIS T 0601 1 25 43 1 44 4 ride 4 2 1 1 2 ASTM F882 84 9 Test Method for Mechanical Integrity 7 2 Mechanical Integrity TN 1
56. 16 169 08 T SE 090 LSEF O 6 2 HB 8 T TMD 1 MAE OT WEG gt 9 9 TA6PT SIF 0 3 4 TL6PT LSIP A GEO RR 2 a 0 1 OZ SS 02 lt 2 9 0D 691 9
57. 6 4 NE 1 JIS 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 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 Temperature Reproducibility 12 Tractive Force Test Method 13 Test Method for Determining the I of Temperature Monitors Cryotip and Tissue 4 2 4 2 1 7
58. MS 0330001 17 8 80 4 4 1 5 1 5 7 8 9
59. TM F882 84 13 Test Method for NS the Accuracy of Temperature MH Cryotip and Tissue 3 3 1 LU i n i 3 4 MG U 3
60. dard 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 JIS T 0993 1 1602 JIS B 7505 JISB 8241 JIS B 8246 ASTM F882 84 ISO10993 7 3 1 OR 2 3 2 3 3 3 4 PHIAP 2 3 5 reseed tindnintat i 3
61. mm 0 om 20 0 45 0mm _b pl 0 4 0mm 2 0 20 0mm 10 0 40 0mm Ol 0 3 0mm 2 0 20 0mm 2 0 8 0mm RL CO RE 422 ASTM F882 84 7 4 Thermal Insulation a 4 2 3 ASTM F882 84 5 4 1 2 4 2 4 JIS B 8246 4 2 5
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