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汎用冷凍手術ュニツ トにおける技術基準
Contents
1. ASTM F882 84 5 4 1 2 4 2 4 JIS B 8246 4 2 5 ASTM F882 84 7 3 1 Cryogen Exhaust 4 2 5 1 ASTM F882 84 7 3 2 Ambient Concentrations of Nitrous
2. 3 2 60 12 ASTM 12 25ppm 2 42 6 60 C 4 2 7 60C
3. 4 2 7 1 ASTM F882 84 11 Test Method for Determining Closed Cryotip Temperature Reproducibility 3 1000mL 1000mL 30 C 2 4 3 4
4. 5 2 Q 17 3 10 0310003 6S 3 47 6 1 495 0 0 gt ASTMF F882 84 62 1 20 C
5. ASTM F882 84 6 2 3 ASTM F882 84 6 2 4 ASTMF882 84 _ 6 2 3 AC ASTM F882 84 6 2 6 JIS T 0601 1 A1 6 ASTM F882 84 6 2 7
6. 2 5 NC 19 6MPa 30 4 2 1 2 JST 0993 1
7. 3 2 1 2 3 4 Ne
8. 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 1 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 ofNitrous 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 ACG of Tiperaiis Monitors Cryotip and Tissue 6 _4 2 4 2 1
9. JIS T0601 1 21 4 2 1 1 ASTM 2 F882 84 7 2 Mechanical Integrity 2 1 1 1 ASTM F882 84 9 Test Method for Mechanical Integrity 3 5 5 JIST 0601 1 25 43 1 44 4 45
10. _ CORRE SC 4 2 8 2 JIS C 1602 S52 4 2 9 JIS B 7505 _ 4 2 10 4 2 11
11. ASTM F882 84 6 2 8 ASTM F882 84 6 2 10 ASTM F882 84 6 2 11 6
12. 6 7 7 1 s1 3 IS T 0601 1 6 6 1 LE JST0601 1 563 a 2 5 1 4 1 2 3 a a 5 1 5
13. 25 gg 0 R250408820100 2 5 5 1 5 1 1 5 ISLE06011 06 1 G3 5 Hz V AVA W _ JIS T 0601 1 61 5 1 2 JIS T 0601 1 6 1
14. 42 112 ASTM F882 84 9 Test Method for Mechanical Integrity 7 2 Mechanical BR 39 JIS B 8241 30
15. 1 4 2 1 3 JIS T0601 1 23 4 2 1 4 ASTM F882 84 3 1 1 closed cryotip gt 42 2 ASTM F882 84 7 4 Thermal Insulation 4 2 3
16. 6 7 3 60 C 3 SC 4 2 8 ASTM F882 84 13 Test Method for Png the Accuracy of Temperature Monitors Cryotip and ao 4 2 8 1 ASTM F882 84 13 Test Method for Determining the Accuracy of Temperature Monitors Cryotip and Tissue 3
17. 1 a 2 JIST0601 1 1 JIS T 0601 1 2 1 SA 2 JIST 0993 1 1 1 JIS C 1602 JIS B 7505 JISE8241 JISB8246 ASTIM F882 84 Standard Performance and Safety Specification for Cryosurgical Medical Instruments ISO 0993 7 Biological evaluation of medical devices Part 7 Ethylene
18. Oxide 42 5 2 lt 4 2 5 3 ASTM F882 84 10 Test Method for ie Ambient Concentration of Nitrous Oxide 2 1 1 28 32 2 13 TE 30qm coom 90cm _
19. oxide sterilization residuajs 3 JIS T 0601 1 JIS T 0601 1 2 JIS T 0993 1 JSC 1602 JIS B 7505 JIS B 8241 JIS B 8246 ASTMF882 84 ISO10993 7 3 1 3 2 3 3 3 4 a 3 S
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