薬食発0331第30号
Contents
1. JIS T 14971 32. eek eres 4 5 11
3. GMP QMS 4 4 REPRE 0330001 17 3 30 4 1 3 7
4. 3 17 3 18 MRI 3 a b c 3 19 PNT IB
5. y 3 5 HEH L ARAFO A EET D l L BENOD FFROEN 3 6 3 7 3 8
6. 1 4 _ 2
7. 4 1 2 3 3 JIS T 14971 _ JIS T 14971
8. 5 6 3
9. 3 E 3 JIS T 14971 ERR I x 0310003 17 3 10 A 2
10. J 0310003 17 3 10 A 6 1 6 2 i JIST 14971 16 2 1 ERKE 02160
11. 4 2 3 I 4 2 3 1 2 20 mm min mm 2 1 l a 0 55 mm 0 75 mm 3N b 0 75 mm 10N 4 2 3 2
12. 5 3 _ 6
13. 2 20 mm min mm 15 N 4 2 3 3 4231 4232 KRUTIB ERARA 20 N 4 3 43 1 v OO 4 4 4 4 1 442 9 2 37 2C 4 4 3 1
14. 3 10 2 JIS T 14971
15. 7 1 2
16. 6 6 1 a b c d ARBRE OT e l f a b
17. 16 169 OPA IME ARNE 16 169 2 3
18. 10mm 50mm 500mm 1 a b 12 1 3 ee 4 RRR 5 6 63 4 1 7 ee 2 5 5 1 k 5 2
19. 5 16 169 5 JIST 14971 6 JIST 14971
20. 6 2 _ 6 2 1 a bd o d e 5 50 mL D 2 10 20 mL 0 0 4903 kPa 0 500 mm KEE h MRI i MRI
21. HADI ATS ERS BE R 2 3 PBT CR 4
22. 17 3 31 0331012 BID 2 5 7 FAM ORES PRL 16 PEENE mana Boe Te 1 122 23 3 31 1 2 1 3 ERD OIRO HO TULA CET 4 e E E EAE 5
23. e 8 6 7 9 300 mm 6 7 10 1 9 b 2 FET 1 4 5 4 5 1 4 5 2 l 37 2 4 5 3 2a Z F 2 b 1 2 3
24. 2 3 4 CRABS A OR
25. a 3 BERG 17 2 16 0216002 4 2
26. 4 1 1 4 1 4 4 1 8 4 1 9 4 1 11 WAJE 4 2 1 1 4 2 1 2 7 JIS T 14971 4 1 2 Z JIS T 1
27. O 3 1 5
28. ceed 4 i ay ARI 16 169 16 169 JIST 14971
29. 2 3 4 l 5
30. 2 20 mm min mm 15N 4 7 4 233 4231 RU 423 2 20 N 2 1 16 169
31. MRI k OBA D m n o p q r s 1 u v ww x y aa bb cc dd 20 mL h ee
32. 444 _ 1 2 3 1 4 5 0 1 6 60 5 mL 10 0 08 kPa l 7 50 mL 30 mL 20 mL 10 mL 5 mL
33. GMP QMS 4 4 RRS 0330001 17 3 30 4 1 3 16 169 8 9
34. 10 4 2 4 2 1 4 2 1 1 0 4 9033 kPa 0 500 mm 0 04 mL min 4 2 1 2 5 C 20 mL 28 a epee 4 2 1 3 4 1 6 42 2 l
35. 8 6 7 l 13
36. 3 9 TEEN 3 10 3 11 3 12 3 13 ERREI T LERNAS EUER RETO DFF 3 14 RETRE E REALDA SIC RR 3 15 3 16
37. 4 1 6 5 50 mL h re Casa i 1 1 mm 2 3 4 1 7 mvivo k X
38. 6 2 2 6 2 2 a b c X d X e g MRI h A A 1 ISO 7197 1997 Neurosurgical implants Sterile single use hydrocephalus shunts and components ISO 14630 2008 Non active surgical implants General requirements ISO 10993 1 2003 Biological evaluation of medical devices Part 1 Evaluation and testing ISO 11134 Sterilization of health care products Requirements for validation and routine control Industrial moist heat sterilization ISO 17665 1 2006 Sterilization of health care products Mo
39. 4 1 8 9 8067 kPa 1 m 4 1 9 B IER 1 0 2 Hz 10 5 N 100 000 4 1 10 MRI ASTM F 2503 05 MRI 4 1 11 19 6133 kPa 2 m 10 2
40. l 4 5 JIS T 14971
41. 2 ep ier o aii marame ol 412 emmnet O OE JMDN in vivo o ER as Ben gt 4 18 4 1 11 4 2 1 2 4 2 1 3 oe 1
42. 3 20 3 21 3 22 ERRESA COD bO TREMBET bO IRISH BAOBAO WRAS EEL HERRARNA EA 3 23 ee ee 3 24 4 _4 1 _ B 4 1 1
43. 10 gt JTS T 14971 ERZE 0310003
44. X ASTMF 640 4 1 2 15 2 13 0213001 JIS T 0993 1 4 1 3 EEO eee tt 4 1 4 9 8067 kPa 1 m 3 4 1 5
45. _ 2 3 4 5
46. _ JEE 4
47. 4 5 4 4 5 4 1 2 a 10mm 50mm 500 mm 1 5 454 2 2b
48. 0 3 3183082 23 3 3 1 eS Ei mA ave ae mA See MHE SH TUS DE Ia a 35 145 14 1 19 2 1 14 9 19 2 5 1 VD B 1 17 2 16 0216002
49. 17 3 10 A 9 l JIS T 14971 JIS T 14971 j JIS T 14971 JIS T 14971
50. JIS T 14971 2
51. l 3 1 4 2 3 1 2 20mm min mm 2 1 a 0 55 mm 0 75 mm 5 N b 0 75 mm 10 N 4 2 3 2
52. 1 1 1 2 l ISO 7197 2006 Neurosurgical implants Sterile single use hydrocephalus shunts and components gt JIS T 0993 1 2005 1 ASTM F 640 79 Standard Test Methods for Radiopacity of Plastic for Medical Use ASTM F 2503 05 Standard Practice for Marking Medical Devic
53. 4 1 2 6 JIS T 14971 _ 8
54. 02 17 2 16 A 2
55. 4971 n 4 1 2 WE BARURKES i JIST 14971 4 1 9 4 2 1 2 2 JIST 14971
56. es and Other Items for Safety in the Magnetic Resonance Environment 0330001 17 3 30 H GMP QMS 4 4 0213001 15 2 13 3 3 1 NABI WEAEOD RADICAL CSE SWIC BR 3 2 RRA HiT PBR OWL TIED ERETO BANC PARER AVX RL RRR HE 3 3 7 3 4
57. ist heat Part 1 Requirements for the development validation and routine control of a sterilization process for medical devices ISO 11135 1 2007 Sterilization of health care products Ethylene oxide Part 1 Requirements for development validation and routine control of a sterilization process for medical devices ISO 11137 1 2006 Sterilization of health care products Radiation Part 1 Requirements for development validation and routine control of a sterilization process for medical devices ISO 11137 2 2006 Sterilization of health care products Radiation Part 2 Establishing the sterilization dose ISO 11137 3 2006 Sterilization of health care products Radiation Part 3 Guidance on dosimetric aspects ISO 11070 1998 Sterile single use intravascular catheter introducers ASTM F 647 94 Reapproved 2000 Standard Practice for Evaluating and RA implantable Shunt Assemblies for Neurosurgical Application _ B Bs B 1 16244000 itih satin
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