薬食発第 03250ー3 号 平成20年3月 2 5日
Contents
1. gt Ys 62. JIS T 14971 1 JIS T 0601 1
3. 5 i i B
4. 3 16 169 JIS T 14971
5. 2 j
6. 1 a 10 0 35 0mm a S b e2 0 4 0mm S ci 2 0 20 0mrn ec 1 a 10 0 33 0mm Fe b pl 5 3 0mm e 20 20 0mm 1 d 20 5 0mm a 10 0 40 0mm b pi 5 3 5mm C d 2 0 30 0mmm a 10 0 40 0mm a bi pl 5 3 5mm bf Ce d 1 5 4 0mm 000 98300 b 2 0 4 0nam 5 cc 2 0 20 0mm i HH 20 0 35 0mm b e0 8 1 5mm a 10 0 35 0mmm b pl 0 2 5mm a 10 0 35 0mm b 01 0 2 5mm 2 0 20 0mm 8 20 0 60 0mm b 1 5 4 0mm 6 d a 2 0 20 0mm 4 0 12 0mm a 20 0 60 0mm b w1 5 4 0mm D1 d 4 0 12 0mm 1e0 b 1 0 2 0mmm 2 0 30 0mm 1 a 25 0 45 0mm 2 be a 15 0 60 0mm lt b pi 0 3 0mm ci 2 0 20 0mnm d di 1 5 4 0mm a 20 0 45 0mm b ol1 0 4 0mm c 2 0 20 0mm
7. ST0993 1 4 2 1 3 JIS T0601 1 23 4 2 1 4 ASTM F882 84 3 1 1 closed cryotip 4 2 1 4 1
8. JIS T 0601 1 WI 15 a i
9. 30 2 19 6MPa 30 4 2 1 2
10. 3 A 5 6 7 3 a 3 g C 4 2 8
11. 3 8 4M RA IS T 0601 1 1 6 1 5
12. 16 8 169 1 5 2 5 9 16
13. 4 2 11 2Sugg ISO10993 7 4 2 12 4 2 1 4 1 3 1 4 1 4 ASTM F882 84 12 Tractive Force Test Method 4 2 12 1 ASTM F882 84 12 Tractive Force Test Method 3 2 NNE SR 15 25 15 17 6 30 0630001
14. 1 1 i 1 1 4 2 8 424 JIS T14971 1 4 25 42 5 1 4 2 5 2 JIS T 0601 1 1 44 4 56 11 d JIST 14971 1 42 5 4 2 5 1 4 2 5 2 a
15. e 2 2
16. JIS T0601 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 D
17. 4 i 4 2 8 2 RA IJISC 1602 4 2 9 1 NN 0 4 2 10
18. 1 gt 1 4 2 8 2 3 4 Mi v
19. 2 5 3 1 4 9 6 2 1 4 1 1 9 2 1 5
20. amp 3 5 NN 3 6 4 4 1 JIS T 0601 1 JIS T 060 1 2 ASTM F882 84 Reapproved 2002 Standard Performance and Safety Specification for OSU CA Medical Instruments ASTM F882 84 Reapproved 2002 Standard Performance and Safety Specification for Cryosurgical Medical instrurments 3 1 closed cryotip 4 Monitoring Devices 6 Disclosure Labeling and Documentation Requirernents 7 2 Mechanical Integrity 7 3 1 Cryogen Exhaust 7 3 2 Ambient Concentrations of Nitrous Oxide 7 4 Thermal insujation 9 Test Method for Mechanical jntegrity 10 Test Method for Determining Ambient Concentration of Nitrous Oxide 11 Test Method for Determining Closed Cryotip T emperature Reproducibility 12 Tractive Force Test Method 13 Test Method for De
21. oe 42 6 60 4 2 7 60C 4 2 7 1 ASTM F882 84 11 Test Method for Determining Closed Cryotip Temperature Reproducibility 3 Q 1000mL 1000mL 30C 2C 2
22. a 5 2 1 2 17 3 10 0310003 3 47 6 1 495 0C ASTM F882 84 4 A 6 2 1 20C
23. i m swea wwww esarser severrre re 1 3 16 169 GMP QMS 0330001 3 30 4 4 1 5 1 5
24. 1 HI JMDN 13700000 O Gn 30 2ZC 1OOOmL 60g _ 1 2 60g O 2 1000mL 3012 O 3 4 35 6 45
25. 1 4 2 5 42 5 1 4 2 5 2 m 3 JIST 14971
26. AH JIS T0601 1 1 21 23 24 25 56 11 9 45 Wnn 1 42 i JIST 0601 1 1 es 1 10 2 2 49 JST 0601 1 2 1 2 36 202 1 4 2 5 42 5 1 4 2 5 2 1 JIS T 0601 1 1
27. 169 2 QMS 5 0330001 7 3 30 4 RN AN 16 1 169 1 5 14
28. 17 10 0310003 mm JIST 14971 ii iii fii ii 1 6 0216002 17 8 31 2 1 2
29. 3
30. ASTM F882 84 6 2 3 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
31. 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 2 3
32. 0 I 17 3 10 0310003 JIST 14971 ee SM 1 0 6 8 et 1 4 2 3 494
33. 3 JIS T 0601 1 1 44 4 447 a mma TTT ome a i Ss OE 16 169 JIS T 0601 1 1 44 4 44 7 i E 2
34. 8 gt 16 169 JIS T 0601 1 1 44 7 See 16 169
35. 1 7 2 1 6 0216002 g 4 2 1 7 3 3 1 0331012 2 5 7 6 50 j 1 956 20 3 25 ea 20
36. 1 3 4 2 5 1 iP 2 JIST0601 1 1 JIST 0601 1 2 1 2
37. 45 5 1 5 1 1 RN JIST 0601 1 6 2 3 4 5 Hz V 6 A VA W 7 8 JS T 0601 1 6 1 ON RO 5 1 2 1 JIS T 0601 1 6 1 6 7
38. 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 EE 4 2 5 3 ASTM F882 84 10 Test Method for 95 Ambient Concentration of Nitrous Oxide 1 1 28 32 2 13 1 1
39. nr OE EERIEMNIK A GENETY OS RO LALA kL GY SiNECME CL 8 6 9 TL6PL STT eg 21 1 T26PT GE 4 2 69T 9 EC A FAO AEFI SR ER EC ERROR 49 3 OS 9 4O OS ESE lCo 1 4 s6 T46 SIE 24 2 gt X 2 1 2 2 ebi
40. JIS T 0601 1 1 JIS 7 1 42 JIS T 14971 16 169 BeW 9 f T DTE T1090 SIT 8 1 O 6Y 05 TY 3 1T
41. JIST 14971 i RS 3 lt
42. 4 gt 6
43. ASTM F882 84 6 2 8 ASTM F882 84 6 2 10 8 ASTM F882 84 6 2 11 2 mw a 1 amp
44. 9 PE ra 5 1 JIS T 14971 sronnc me 1 a A
45. 1 63 JIST 14971 OM 5 MA JIS T 0601 1 1 6 3 C 1 1
46. gt 5 NT TOTTI 1 4 a 16 169 JIS T 0601 1 1
47. i _ 16 169 1 4 2 2 42 5 4 2 5 1 4 2 5 2 3 ee 1 6 1 5
48. JST 14971 JIST 14971 5 1 1 2 36 202 JIST 14971 a JIS T 0601 1 1 2 25 42 1
49. 1 7 IS i 7 19 20 58 ree mn daneanassasmmrererrr eeea 13 RI 1 21 28 24 45 1 4 2 HE JIS T 0601 1 od
50. 7 1 5 1 3 JIS T 0601 1 6 6 JIS T 0601 1 36 3 a 2 5 1 4 1 2 3 5 1 3
51. 7 16 169 GMPZQMS 0880001 7 3 830 4 4 0 5 4 2 10 a
52. JST 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 _ ISO10993 7 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals 3 JIS T 0601 1 JJS T 0601 1 2 JIS T 0993 1 JIS C 1602 JIS B 7505 JIS B 8241 JIS B 8246 ASTM F882 84 ISO10993 7 3 1 3 2 3 3 3 4
53. i Man 342 170 30cm 5 90cm 92080 6 UE 3 2 60 12 ASTM 12 25ppm
54. 0325013 20 3 2 5 DE ANE Bhatseita gotottrmn in tration ie 3 5 1 4 5 1 4 1 1 9 2 1 1 4 9 1 9 2 5 I VD a 1 1 7 2 1 6 0216002
55. 91 1 2 JIST 14971
56. 1 JTST060112 i 48 52 56 57 5 2 JISF 14971
57. 24E K v 8 YG LEIOLE LR a 69 9T SA sao 8 ioe 7 JIS FT 14971 ir ug Qo A 0 0213001 15 2 13 1 4
58. 5 JIST 0601 1 2 1 2 gt _ 86 201 JIST 0601 1 2 1 6 4 2 1 86 209 JTS T 0601 1
59. 0 56 3 a 57 58 1 4 2 3 424 JHST 14971 j JIS T 0601 1 1 42 1 4 2 2 1 4 2 7 4 2 8 1429 2 Ne
60. a 1 JTS T1497 3 1 4 2 5 1 0 1 42 7 9 te 4 2 8 42 9 2
61. a 10 0 40 0mm b gpl 0 3 0mm 2 0 20 0mm d 2 0 8 0mm ASTM F882 84 7 4 _ Thermal Imsulation 4 2 3 ASTM F882 84 5 4 1 2 4 2 4 JIS B 8246 4 2 5
62. 2 1 2 ei aitai i in 1 42 JIS T 0601 1 1 48 1 JIS T 14971 2
63. termining the Accuracy of Temperature Monitors Cryotip and Tissue 4 2 4 2 1 HIS T0601 1 21 4 2 1 1 ASTM F882 84 7 2 Mechanical Integrity 4 2 1 1 1 ASTM F882 84 9 Test Method for Mechanical Integrity 3 3 5
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