野薬食発第 03250ー3 号
Contents
1. 6 GEA2. 16 I 169 2 JIS T 0601 1 1 44 7 REZ i 16 DWERSE JIST 0601 1
3. 1 42 8 2 3
4. 1 44 4 56 11 d GEREZA JIST 14971 3 1 4 2 5 42 5 1 425 2 8
5. 1 7 2 1 6 0216002 4 2 1 7 3 3 1 0331012
6. 2
7. JIST0993 1 1 4 213 JIS TO601 1 23 XH AROW 4 2 1 4
8. TU JIST 14971 JIST 0601 1 2 1 2 38202 JIST 14971 2
9. JIS T 0601 1 ORTER A KEIR 1 6 SEa 0 1 FR 174 5 E3 10 BRAKE 0310003 JIS T 14971
10. 16 BA 169 f GMP QMS 0330001 7 3 30 4 4 GREL 4210 8 A
11. 5 w JIST 14971 GKL 425 4 2 5 1 4 2 5 2 6 JTS T 0601 1
12. 8 JIS T 0601 1 1 25 42 43 52 56 57 59 1 52 5 JIS T 14971 3 i
13. 3 4 16 169 2 JIS
14. j 3 6 4 4 1 JS T 0601 1 JIST 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 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 12 Tractive Force Test Method i 13 Test M
15. 5 ASTM F882 84 6 2 10 O ASTM F882 84 6 2 11 2 GEH 1
16. vy BEROTHRE D E il BEBE ERUEN BL EISER AE OIRE L ORE F JIST 14971 0213001 5 2 13 R 1 4 2 1 2 1 4 2 JIS T 0601 1 1
17. JE H Bv C
18. 30 D a kapo CH UFORIRE k o TREERE Z Sky n 19 6MPa 30 i 4 2 1 2
19. FEGH Xk kok 4 6 4 2 8 2 eh Es PORREN EOD a ile
20. 16 FREN 84616 GMP QMS CERED 0330001 17 8 80 4 4 RESI Fray 1 5 1 5 7 sta
21. 16 169 2 1 i 422 4 2 5 42 5 1 4 2 5 2 3 GEL 5 t JIST 0601 1
22. JIS T 14971 1 42 5 1 0 GKL 42 7 42 8 42 9 2
23. 42 7 60 42 7 1 ASTM F882 84 11 Test Method for Determining Closed Cryotip Temperature Reproducibility 3 1 1000mL 1000mL 30C 2
24. JIS T 0601 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 3 39 JIS B 8241 1 vo O o g 5
25. 2 5 7 16 298 1 956 20 3 25 I 1 2 1 3 4 2
26. 7 8 BH Akk A 1 2 JIST 14971
27. 1 6 1 5 2 TRARRE TIZA IRER DREA fsla FRERET D k RR 3
28. 1 42 JIST 14971 GEREZA P 3
29. JIS T0601 1 2 1 2 mE ERREUR 86 202 7 JIS T 0601 1 1 7 19 20 MEE 58 1 3
30. JIS T 0601 1 56 3 a 2 514 1 HEATHA 2 G 5 1 5 2 1 2 17 3 10 0310003
31. ASTM F882 84 6 2 5 AC DR 2 E 3 2 BSI lC db TII TAERA TEONE RURE ASTM F882 84 6 2 6 JIS T 0601 1 A1 6 ASTM F882 84 6 2 7 O ASTM F882 84 6 2 8
32. 16 FERIERE 169 JIS T 14971 1 6
33. E ELERE ER JIST 14971 JIS T 0601 1 RF 21 23 24 PH 25 45 1 42 H ANO TAUFRE ARD O ORE ERR JIST0601 1 1
34. vx 3 Vy 4 JIST 14971 i f
35. 1 6 AS maah 0216002 17 8 81 2 1 2 2 ERRIRE T
36. 3 ARFER RIEC U ARF 72 ukhhiitikoy rh ci 4 5 6 7 3 60C 3 5C hs 42 8
37. m es JIS T 0601 1 2 1 JIS 7 MEN gl
38. 10 2 2 49 JTST 0601 1 2 1 2 36202 1 4 2 5 4 2 5 1 4 2 5 2 JTS T 0601 1 1 RY 56 PH LD CEREZA JIST 14971 E
39. 3 JIST 14971 GREL 423 42 4 4
40. 6 5 1 1 2 JIST0601 1 1 JIS T 0601 1 2 1 2 PATINE JIS T 0993 1 1 JIS C 1602 JISB 7505 JSB8241 JIS B 8246
41. 1 1 7 2 1 6 0216002 2 O a PE OAR Rie f 3 1 4 9 6 2 1 4 1 1 9 2 1
42. 42 53 ASTM F882 84 10 Test Method for Petsrinining Ambient Concentration of Nitrous Oxide 1 Z 1 1 2832 2 13 ka k f 1 fr mt zl EER jii N g 4 Kis RAM 14217 0 30gn WEA 90cm
43. ASTM F882 84 3 1 1 closed cryotip 4 2 1 4 1 x 1 1 a 10 0 35 0mm i a b g2 0 4 0mm Ci 2 0 20 0mm 5 ze a aZ e a a 9 a T gt a 10 0 35 0mm pen 1 b gp1 5 3 0mm_ t c 2 0 20 0mm MIERNE mo d 2 0 3 0mm I 1 3 a 10 0 40 0mm a b g1 5S 3 5mm TOY C c 2 0 30 0mm Q Cus dt 152 40mm_ 12 en a 10 0 40 0mm 1 b 1 5 3 3mm K d 1 5 4 0mm D a 10 0 35 0mm z n b g2 0 4 0mm ST c 2 0 20 0mm 3 1 a gt a 20 0 35 0mm b 0 8 1 5mm 1 a a 10 0 35 0mm b g1 0 2 5mm U P l 2 a 10 0 35 0mm NN b e1 0 2 5mm tf c 2 0 20 0mm 5 0 hig a 20 0 60 0mm BT b g1 5 4 0m
44. 3 4 5 RE 6
45. ER 16 WERN 1695 GKL 5 2 5 9 WE 16 EREN WERE 1695 GM
46. ASTM F882 84 13 Test Method for Determining the Accuracy of Temperature Monitors Cryotip and Tissue 4 2 8 1 GI ASTM F882 84 13 Test Method for Determining the Accuracy of Temperature Monitors Cryotip and Tissue 3 33 G 1 2 3 IE HH Wk HE Be G FRS E
47. ER 16 169 2 HKEE LARARE ET E POSEES T 1090 L SIC KARAN ZY EA SB TY D dz EE EA Bgo MAOA LAKS x f EERE TL6PT L SIF PERITE SB o uya st ITARTE LRAORE LURI RZ BNK ERRTU SMAUG Zx KL CHAPEL uya s AQ EY uy DC QE T2S k ZW FIp6H Prur o AR ORPA KIN ELORE BR ZITO VNLURYS PAOA Ck Zx RER Zx G 2 SERRES 26PT L SIP c30218Rng nrouae AYORALAN NRE CE 69T KLERAN 9T ELG PALA LERARO AARNA Yk SELERI SHOREN R ERCA UR RANAR LOH BB Wa a sc mas AIRNE KUPRO wao asema T s o HUMEN ARA 22 gr H EQ EINAR Haoi 22 2 AD 1 SE AG CD QQ SANE gm 4 2 C G3FE2 ZV ERLE KL Zam o p 215162 Y tr REEERE ASEET TL6PT L SIC IARU s as 2603938890 Se SEP NEREA RO A a E I E NE OREIN A E A CETERI IRE C HERI GARELA ALAKE ye LFO 002 ORE ERTO mOc popoe KARE AR ASE BAINO YESTEONM AIRTER WOVE EE ORANA ARE FE IHME A ARE 2 PT Hk oN 7
48. 4 5 JIS T 0601 1 2 1 SEEI DoE E RARU ES NTO 2 86201 6
49. 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 I 3 1 3 2 33 3 4 W Co 1 a 3 5
50. 1 44 4 44 7 WB YB URPI Z 16 169 22 JTS T 0601 1 1 44 4 44 7 Wii ERORE 2 A 3
51. 43 1 2 b 4 E PIECON TRSH boru br JIS T 14971 GKE 1 4 25 4 2 5 1 4 2 5 2
52. 2 1000mL 30 2 O 3 4 S 6 45 45 5 5 1 5 1 1 JIS T 0601 1 6
53. 9oan 42 6 60C 3 2 60 12 ASTM 12 25ppm
54. 1 4 2 2 1 4 1 42 7 4 2 8 4 2 9 2
55. A JIS T 0601 1 1 6 3 5 JIST 14971 JIS T 0601 1 1 1 6 3 i 1 1
56. JISC1602 429 5 4 2 10 4 2 11 4 2 12 4 2 1 4 1 F 4 2 12 1 fk 15 25 17 3 AR 8 ISO10993 7 4 1 4 AST x ASTM F
57. 3 10 0310003 JIST 14971 JTS T 0601 1 1 6 8 OREL 423 424 5 2 MRSA 9
58. a 0325013 20 3 25 a ME JH sabes tali H EE 3B45 Pest 8 n 3 5 1 4 5 1 4 1 1 9 2 1 1 4 9 1 9 2 5 I VD
59. 3 4 47 6 1 495 2 6 O 5 S fJ X phi gy fiks c OOTO 0 ASTM F882 84 6 2 1 20C ASTM F882 84 6 2 3 I I ASTM F882 84 6 2 4
60. ASTM F882 84 5 4 1 2 4 2 4 1 JIS B 8246 425 ASTM F882 84 7 3 1 Cryogen Exhaust 4251 5 ASTM F882 84 7 3 2 Ambient Concentrations of Nitrous Oxide 4 2 5 2 EROTEL IMHT a Z Laok gt
61. JIS T 0601 1 1 21 23 RE ARU 24 1 45 GREL f 42 JIS T 14971 2 ay RUES
62. T 0601 1 1 10 56 3 a 57 58 1 423 42 4 JIST 14971 j 5 JTS T 0601 1 1 42
63. 1 D 3 4 5 Hz V 6 A VA W 7 8 JIS T 0601 1 6 1 5 1 2 1 JIS T 0601 1 6 1 6 7 7 1 5 13 JIS T 0601 1 6 6 1
64. 882 84 12 Tractive Force Test Method 3 S lt JMDN 13700000 15 E JIS B 7505 25ug g m M F882 84 12 Tractive Force Test Method F 6 30 0630001 1 L O 19mm 8 5rrmR 1 T OK E AROR J 30 2C 1000mL 60g 1 2 60g O
65. P QMS I ARRA 0330001 7 8 80 4 4 1 0 QR 16 169 GKL 5 14 17
66. ethod for Determining the Accuracy of Temperature Monitors Cryotip and Tissue 42 42 1 JIS T0601 1 21 42 1 1 ASTM F882 84 7 2 Mechanical Integrity 4 2 1 1 1 ASTM F882 84 9 Test Method 0 Mechanical Integrity S O y p wees L 3 3 5
67. m ILERE i I T c 2 0 20 0mm d 4 0 12 0mm 2 52 i a 20 0 60 0mm n b g1 5 4 0mm bf V d 4 0 12 0mm 6 1 Tamara a 25 0 45 0mm TN b g1 0 2 0mm WC f c 2 0 30 0mm 7 I a a 15 0 60 0mm p b 91 0 3 0mm bl V c 2 0 20 0mm d 1 5 4 0mm L 1 T2 a 20 0 45 0mm i a RAEE b g1 0 4 0mm i bT c 2 0 20 0mm 1 a T m a 10 0 40 0mm Bf b g1 0 3 0mm c 2 0 20 0mm Ju d 2 0 8 0mm T 4 2 2 B ASTM F882 84 7 4 Thermal Insulation 423 GRE
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