原生労働省医薬食品局長野
Contents
1. 30 2 19 6MPa 30 2 1 22. 4 2 5 1 1 2 JIST0601 1 1 JIST 0601 1 2 1 2 JIST0993 1 1 JISC 1602
3. 1 1 a 10 0 35 0mm 1 b gp2 0 4 0mm a 10 0 35 0mm b pl 5 3 0mm ec 2 0 20 0mm g d 20 5 0mm PP pl1 5 3 5mm 2 0 30 0mm Q ol 4 yj lt gt i 2 lo i a ea A oo oo 10 0 40 0mm pl 5 3 5mm 1 5 4 0mm a 10 0 35 0mm TL b e2 0 4 0mm C _ b1 c 2 0 20 0mm 5 3 1 a 20 0 35 0 AI 6 b b 00 8 1 5mm 1 4 1 Na a 10 0 35 0mm 1P b e1 0 2 5mm 4 a 10 0 33 0mm ei RE b 01 0 2 5mm c 2 0 20 0mm 1 a 20 0 60 0mm bt c b e1 5 4 0mm 1 1 c 2 0 20 0mm Ge ed d 4 0 12 0mm a 5 2 4 A a 20 0 60 0mm b e1 5 4 0mm bt T d 4 0 12 0mm 6 1 a 25 0 45 0mm c 2 0 30 0mm a 15 0 60 0mm b pl 0 3 0mm c 2 0 20 0mm d 1 5 4 0mm a 20 0 45 0mm MM c 2 0 20 0mm 1 a 6 a 10 0 40 0mm 6 b 1 0 3 0mm c
4. 25ng g ISO10993 7 4 2 12 4 2 1 4 1 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 2 5 25 15 17 6 30 0630001 1 HL JMDN 13700000 2
5. JIS T 0601 1 2 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
6. 5 1 1 JIS T 0601 1 6 1 2 3 4 5 Hz V 6 A VA W 7 8 JIS T 0601 1 6 1 1 2 1 JIS T 0601 1 6 1 6 7 7 1
7. 4 2 7 60 4 2 7 1 ASTM F882 84 11 Test Method for Determining Closed Cryotip Temperature Reproducibility 3 1 1000mL 1000mL 30C 2 2
8. 4 5 6 7 3 60 3 5 4 2 8 ASTM F882 84 13 Test Met
9. 9ocm 9ogn 3 2 60 12 ASTM 12 25ppm i a 4 2 6 60
10. a IST0993 1 1 4 2 1 3 CN Tl I 4 2 1 4 ii ASTM F882 84 3 1 1 closed cryotip 4 2 1 4 1
11. 4 2 1 7 3 3 1 0331012 2 5 7 16 298 1 956 20 3 25 2 1 3
12. 3 1 3 JIS T 0601 1 6 6 1 JIS T 0601 1 56 3 a 2 5 1 4 1 2 3 5 1 5
13. 19rmm 30 2C 1000ormr 60g 1 2 60g O 2 1000mL 30 2C O 3 4 5 6 45 45 5 5 1
14. 5 2 1 2 17 3 10 0310003 3 4 47 6 1 495 5 0C ASTM F882 84 6 2 1 20
15. 0325013 20 3 25 is MAP 1 9 2 1 1 4 9 1 9 2 5 ON I VD 1 7 2 1 6 0216002
16. 3 5 3 6 4 4 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 S 4 Monitoring Devices 6 Disclosure Labeling and Documentation Reduirements 7 2 Mechanical Integrity 7 3 1 Cryogen Exhaust 7 3 2 Ambient Concentrations of Nitrous Oxide 7 4 Thermal Insulation 9 fest Method for Mechanical Integrity 10 Test Method for Determining Ambient Concentration of Nitrous Oxide 11 Test Method for Determming Closed Cryotip Temperature Reproducibility 12 Tractive Force Test Method 13 Test Method for Determining t
17. ASTM F882 84 6 2 8 ASTM F882 84 6 2 10 ASTM F882 84 6 2 11
18. 2 1 3 1 4 RG ET TN 1 4 1 1 9 2 1 0 Ss 1 7 2 1 6 0216002
19. 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 JIS 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
20. 4 5 NN NE 2 5 tS 4 2 8 2 JIS C 1602 4 2 9 JIS B 7505 4 2 10 4 2 11
21. 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 Al 6 ASTM F882 84 6 2 7
22. 2 0 20 0mm 8 d 2 0 8 0mm Tt 4 2 2 ASTM F882 84 7 4 Thermal Insulation 4 2 3 ASTM F882 84 5 4 1 2 4 2 4 JIS B 8246 4 2 5 SD RL ASTM F882 84 7 3 1 Cryogen Exha
23. he Accuracy of Temperature Monitors Cryotip and Tissue 4 2 4 2 1 JIS 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
24. hod for Determining the Accuracy of Temperature Monitors Cryotip and Tissue 4 2 8 ASTM F882 84 13 Test Method for Determining the Accuracy of Temperature Monitors Cryotip and Tissue 3 Ra 2 1 3 GR
25. ust 4 2 5 1 MC 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 13 142 17 0 3oam
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