薬事法 (昭和3 5-年法律第ー4 5号。 以下 「法」 という。) 第ー 4条第ー項
Contents
1. 4 a 2 Es 5 J 1 et2. a 15 _ PT ri 9 _ 2 3
3. 2 J JIST 0601 1 1 a JIS T 0601 1 2 1 bo 2 JIST 0993 1 2 JIS C 1602 JISB 7505 JISB8241 JISB8246 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 JIST 0601 1 IIST 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
4. 9 4 _
5. ST 0601 1 5 at TDD 1 6 Ea 2 ST 0601 1 6 8 i RS 1 3 17 3 10
6. a 4 2 6 60 _ Cs 4 2 7 60C 8 ea 42 7 1 ASTM F882 84 11 Test Method for Determining Closed Cryotip Temperatute Reproducibiity 3 a a 1 1000mL 1000mL
7. ASTM F882 84 13 Test Method for Determining the Accuracy of Temperature Monitors Cryotip and Tissue 3 42 8 1 ASTM F882 84 13 Test Method for Determining the a of Temperature Monitors Cryotip and Tissue 3 3 1 6 2
8. _ 3 2 3 3 3 4 3 5 3 6 4 _4 1 JJIS T 0601 1 JIS T 0601 1 2
9. _ re jE jTs 14971 lt E 1 UIS T
10. 3 5 6 a i _ ee TS T 14971 amp ge gt 1 a ls 4 1 42
11. 9IS T 14971 RZ ST 0601 1 5 6 8 1 4 2 3 4 2 4 5 2 8 9 5 HIS T 14971
12. 47 6 495 EAI OD ASTM F882 84 62 1 20 C ASTM F882 84 6 2 3 ASTM F882 84 6 2 4 6 2 5 AC
13. 1 5 2 9 _ 16 Ls NR A 0830001 17 3 80 4 4
14. 3 5 HIT 19 6MPa 30 4 2 1 2 JST 0993 1 1 4 2 1 3
15. _ 3 _ 4 A 0 2 16 169 IST 0601 1 10
16. a 0 i HIS T 14971 JTS T 0601 1 2 1 5 2 36 202 IS F 14971 SF 0601 1 5 25 42 43 52 56 57 UC
17. 1 4 2 3 FM TO 5 1 5 RO 5 2 Q 17 3 10 0310003 a 0 Ne Es
18. 2 RA 5 3 1 4 9 6 2 1 4 1 1 9 2 1 1 7 2 1 6 0216002
19. _ 8 8 TS _ _ _ 30 5 2
20. 3 ND 5 co 4 Me 5 Ne 4 2 8 2 JIS C 1602 5 42 9
21. 5 6 8 EE _ 7 Br CA
22. JIS B 7505 4 2 10 4 2 11 ISO10993 7 5 a 5 1 a EL 5 1 1 IS T 0601 1 6 _ eid 3
23. JIS T0601 1 23 4 2 1 4 ASTM F882 84 3 1 1 closed cryotip 4 2 2 2 ASTM F882 84 7 4 Thermal Insulation 4 2 3 di ASTM F882 84 5 4 1 2 4 2 4
24. 48 1 2 RE pa _ _ 3 EE _ 8 SI 1 4 2 5 2 5
25. 4 3 Hz V 6 AVA W a IS T 0601 1 6 1 5 4 2 a JIS T0601 1 61 67 7 1 51 3 IS T 0601 1 6 6 1 JIS T 0601 1 363 a
26. 16 0 _ HH69 _ _ 2 _
27. JSTB 8246 42 5 ei _ _ 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 PD RI 4 2 5 3 ASTM F882 84 10 Test Method for Determining Ambient Concentration of Nitrous Oxide 9 en J 1 28 32
28. lt TS T 14971 ie 8 9 1 2 5 Sa 4 2 5 1 4 2 5 2 ST 0601 1 6 RE BE 3 a 44 4 a 83 56 11 d 8 1 4 2 5 4 2 5 1
29. ASTM F882 84 6 2 6 JIS T 0601 1 A 6 ASTM F882 84 6 2 7 RR ASTM F882 84 6 2 8 ASTM F882 84 6 2 10 0 ASTM F882 84 6 2 11 2 1
30. TIS T 0601 1 1 23 24 45 9 2 UTST 0601 1 10 2 2 49 ST 0601 1 2 HP 2 36 202 0 1
31. RM 4 _ _ i i 6 a 1 VY 2 ee 86 202 1 19 20 7
32. 11 My by ee _ RE 2 i a 3
33. 16 169 3 2 0 gt EE 1 2 2 4 2 5 2 5 1 4 2 5 2 1 8
34. a 2 13 Ee 4 ro 30cm gOcm 90crs 3 2 60 12 ASTM 12 25ppm
35. 16 169 1 8 7 7 _ Ry i 99 16 en 2 16 4 PA 169 8
36. 4 5 6 B 7
37. 1 S T 0601 1 7 hrchr US 0 g TT 14971 nN eg 0218001 15 2 13 42 12 1 42 ST 0601 1
38. 4 2 5 fr 3 4 2 5 1 4 2 5 2 _ 8 _ 3 2 j 3 ee 56 11 9
39. H A 4 2 i 1 7 3 3 1 0331012 EO 2 5 7 16 298 1 955 19 3 2 3 2 1 3
40. 16 169 1 0 1 5 1 4 ll 17 8 10 0810008 2
41. 0302012 1 9 3 2 PE ll 1 Pb 0 od SS j on 3 5 1 4 5 1 4 1 A RG 1 4 1 9 2 5 _ I VD 1 1 7 2 1 6 0216002
42. 2 5 2 8 _ Ah 2h IST 0601 1 4 7 16 ie TST
43. 56 8 a 57 58 9 5 4 2 8 4 2 4 HTS T 14971 IS T 0601 1 NP TI HE WPM 1 4 2 7 4 2 8 4 2 9 8
44. _ 0810008 HIS T 14971 0331032 17 3 31 2 1 2 A or 2
45. _ 0 8 1 2 EMiPSMGkete 0 8 3 0 gt
46. 8 JTS T 0601 1 1 1 8 24 45 13 Pon 3 0 4 2 MIS T 14971 2
47. F882 84 7 2 Mechanical Integrity a 42 1 1 1 ASTM F882 84 9 Test Method for Mechanical Infegrity a 9 3 5 5 JIS T 0601 1 25 43 1 44 4 45 1 42 1 1 2 ASTM F882 84 9 Test Method for Mechanical Integrity 7 2 Mechanical 39 JIS B 8241 1
48. 0601 1 F 1 44 4 44 7 RA 169 2 6 3 _ E
49. 1 4 2 5 2 8 T14971 3 1 7 4 2 8 4 2 4 a a a hs 4 _ 5 E _
50. 30 2 Ma 2 3 4 5 5 GE 6 7 3 60C 3 _ SC IGR 42 8
51. ASTM F882 84 Reapproved 2002 Standard Performanmce and Safety Specification for Cryosurgical Medical Instruments 3 ASTM 862 84 CRespproves 2002 Standard eC and Safety Specification for ES Medical Instruments 3 1 1 closed cryotip 5 4 Monitoring Devices 6 Disclosure Labeling and Documentation Requirements 9 2 Mechanical Integrity 7 3 1 Cryogen Exhaust EE 7 3 2 Ambient Concentrations ofNitrous Oxide 7 4 Thermalfmsulation 9 Test Method for Mechanical Integrity 10 Test Method for Determining Ammbient Concentration of Nitrous Oxide 11 Test Method for Determining Closed Cryotip Temperature Reproducibility 13 Test Method for Determining the OY of SN Monitors Cryotip and _ Tissue _4 2 4 2 1 _ JIS TO601 1 21 _ 4 2 1 1 ASTM
52. 14971 3 MN 16 169 16 169 _ 1
Download Pdf Manuals
Related Search