各都道府県知事 殿 汎用冷凍手術ユニッ ト承認基準の制定について 薬事法
Contents
1. E LE 3C2. 22 ClL7EV 5 6 I en REF One
3. IS T 0601 1 1 6 BALLS rn SEE 1 5 Er HRS 17 3 10 ARE 0310003 MiS T 14971
4. 4 2 4 5 1 1
5. Ses 3 1 4 9 6 2 1 4 1 1 9 2 1 nn a e 1 7 2 1 6 0216002 nal
6. 2 JIST 0601 1 1 JIS T 0601 12 1 2 JIST0993 1 1 JIS C 1602 JIS B 7505 JISB8241 JIS B 8246 en 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 JIS T 0601 1 2 JIS T 0993 1 JIS C 1602 JIS B 7505 JIS B 8241 JISB 8246 ASTM F882 84 IS010993 7 3 1
7. NR ES o aul 1 2 2
8. Be AAA RARE RO PALO a u 2 nn 5 IS T 0601 1 1 6 TIO MEE 3
9. HEROZ ert 3 VA ie 0 A ORBLE RRP Ca oe ime 4 MTS T 14971 BIR 1 4 2 7
10. 1 14 2 5 4 2 5 1 4 2 5 2 8 RE LB 3 16 169 NL 7 MIS T 06011
11. 6 f ee 2 36 201 AUIS T 0601 1 2 1 2 36 202 een IS T 0601 1 1 7 19 20 58 7
12. ee 8 Es an ee een 30 295 2
13. 5720 _ 7 INH 16 169 HT Sie kOe EE GMP Q MS 0330001 17 3 4 4 10 RARO A
14. _ 3 2 33 3 4 Es 3 5 3 6 4 41
15. 19 6MPa 30 4 2 1 2 JIS T 0993 1 1 4 2 1 3
16. 3 ES 5 0213001 15 2 ee 13 N 6 42 12 mo BUG 1 a CHATAL LER 42 ER IS T 0601 1 43 1 1 4 2 5
17. A 1 CBE 16 O ne
18. 16 169 al 1 5 1 4 _ 17 3 10 0310003 2 MIS T 14971
19. 3 gt 8 MTS T 14971 1 4 2 8 2 4 BE AQUA MA 5
20. 1 MUIS T 14971 Be A lt HTS T 14971 3 8 8 AR 1 4 2 5 10 _ O EDA 2
21. 4 47 6 1 495 5 a Den 0C ASTM F882 84 ae 20C ASTM F882 84 6 2 3 ASTM F882 84 6 2 4 O RE
22. 4 5 6 CERRAR RR Chaz
23. JIS T 14971 A AMR AA EE ERRORES BRI 2 EA
24. 1 6 E 2 0331032 17 3 31 2 1 2
25. 4 2 1 7 3 3 1 0331012 BIER HA 2 5 7 16 298 1 955 19 8 2 1 2 1 3
26. 3 MIS T 0601 1 1 bh 6 8 FIL 1 4 2 3 4 2 4 5 2 9 KOSS HIS T 14971 JIS T 0601 1 1 BM 21 23 24 25
27. JIS B 8246 4 2 5 ASTM F882 84 7 3 1 Cryogen Exhaust 425 1 ASTM F882 84 7 3 2 Ambient Concentrations of Nitrous Oxide 425 2 7 425 3 ASTM F882 84 10 Test Method for Determining Ambient Concentration of Nitrous
28. a 16 169 cela DO A 4 4 IE 1 5 15 16 169 7 _
29. JIS T 0601 1 56 3 a 2 514 x 1 ERRATA 2 WEA 3 515 52 1 2 17 3 10 0310003 6 3
30. 169 IS T 14971 d JIS IS T 0601 1 7 GI 1 42 MUTIS T 14971 7
31. 44 7 16 169 SE o JIS T 0601 1 44 4 44 7 EPR OA FEO MECA 16 FEV 169 MIS T 0601 1 44 4 44 7
32. 2 3 E 1d RB 1 6 4
33. 5 1 1 JIS T 0601 1 6 1 2 3 4 5 Hz V 6 A VA W 7 15100116 ELLO 5 1 2 KONE 1 JIS T 0601 1 6 1 6 7 e E ars 513 CERES JIS T 0601 1 6 6 1
34. MUTS T 14971 BR 1 4 2 5 4 2 5 1 4 2 5 2 IS T 0601 1 1 44 4 56 11 Y 6 3 MIS T 14971
35. 60C 3 5C 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 1
36. 3 4 AR E 16 169 IST 0601 1 eh REIN z Ren 10 56 3 a 57 58
37. ASTM F882 84 7 2 Mechanical Integrity 2111 cn ASTM F882 84 9 Test Method for Mechanical Integrity 3 _ 5 5 JIS T 0601 1 25 43 1 44 4 45 42 112 ASTM F882 84 9 Test Method for Mechanical Integrity 7 2 Mechanical Integrity 39 JIS B 824 1
38. 211 2 Y HERE _ 3
39. 4 2 8 4 2 9 2 UIS T 0601 1 Pl 16 3 MIS T 14971 5 3 IST 06011 6 3 WR
40. ASTM F882 84 6 2 5 AC ASTM F882 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
41. No 2 Nor 3 N 4 we 5 Nal 42 82 JIS C 1602 ar 429 JIS B 7505 42 10 4 2 11 25 gg ISO10993 7 5 51
42. ER j 2 CE
43. 4 2 7 4 2 8 4 2 9 16 ERBOR 2 SERS R SRO dhe 1 3
44. 0302012 amp 19 3 2 RENTAS Be 3 5 1 4 5 1 4 1 1 9 2 1 1 4 9 1 9 2 5 I VD FRI 7 2 1 6 0216002
45. BS O a ee ca NN GMPQ IMS 0330001 17 3 30 4 4 a VEE 8 Calls 1 4 2 10 B 16 8 p 9 4REREA
46. JIS T0601 1 23 4 2 1 4 ASTM F882 84 3 1 1 closed cryotip e yl 2 Y om ats 4 2 2 BR ASTM F882 84 7 4 Thermal Insulation 423 ASTM F882 84 3 4 1 2 424
47. RNN 0 Po ma 213 Biker DER AAA UIS T 0601 1 1 3 21 23 24 45 UR 1 4 2 HIS T 14971 nen A A id 2 rg qa
48. JIS T 0601 1 JIS T 0601 1 2 ASTM F882 84 Reapproved 2002 Standard Performance and Safety Specification for Cryosurgical Medical Instruments ea ASTM F882 84 Reapproved 2002 Standard Performance and Safety Specification for Cryosurgical Medical Instruments 3 1 1 closed cryotip 5 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 13 Test Method for Determining the Accuracy of Temperature Monitors Cryotip and Tissue 42 4 2 1 JIS T0601 1 21 4 2 1 1
49. 4 2 5 1 4 2 5 2 _ MIS T 14971 1 4 2 3 4 2 4 4 3 5 A 5
50. 60 12 ASTM 12 25ppm 42 6 60C 42 7 60C 4 2 7 1 ASTM F882 84 11 Test Method for Determining Closed Cryotip Temperature
51. pig IIA 1 4 2 3 42 4 MIS T 14971 IST 0601 1 1 5 RUT E 1 1
52. Oxide des 1 1 28 32 2 13 142 17 0 30gmn gocm 9oan 3 2
53. Reproducibility SK 3 1 1000mL 1000mL 30 C 2C SA 2 3 4 5 6 ERRE KIILTIRFY TEHREIIRL BESHE FIILTEIERET N 3
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