薬食発0331第30号 (PDF : 2MB)
Contents
1.2. JIS T 14971 JIS T 14971 JIS T 14971 JIS T 14971 0310003 17 3 10
3. 2 HI 4231
4. E 2
5. 1 5 2
6. 4 AP Me 5
7. 6
8. 1 1 mm 2 3 4 1 7 in vivo gt 7 gt X 4 1 8
9. ISO 7197 2006 Neurosurgical implants Sterile single use hydrocephalus shunts and components JIS T 0993 1 2005 1 ASTIM F 640 79 Standard Test Methods for Radiopacity of Plastic for Medical Use ASTM F 2503 05 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment 0330001 17 3 30 A GMP QMS 4 4 3 3 1
10. 6 2 6 2 1 a b c d e 5 50 mL D g 10 20 mL
11. NN 1 4 2 N 3
12. 5 JIST 14971 4 1 2 6 JIS T 14971
13. 16 169 2 3
14. JIS T 14971 3 16 169 l 4
15. 8 16 169 5
16. 16 169 JIS T 14971 5
17. 2
18. 3 l 4 5
19. 3 4 5 11
20. 8 1 2
21. DUTTA SD KOR BOER ULE 2 OO ae X 3 i
22. JMDN 16244000 gt _ 1 ee See 4 1 4 1 1 4 1 2 olol gt o O 4 1 3 4 1 4 4 1 5 O O A A O O O O O O A A 4 1 6 ak OIOTOIOIOIOIOIO 4 1 7 in vivo 4 1 8 MRI 2 RRE 4211 O gt ae io O ALA LM a m o O 4 2 1 2 TERIB SBR OLBE CO Esl CE eS 1
23. JIS T 14971 0310003 17 3 10 A 9 i JIS T 14971
24. 2 20 mm min mm 15 N 4 23 3 4 2 3 1 RU 4 2 3 2 20 N 4 3 43 1 l 4 4 4 4 1 4
25. JIST 0993 1 4 1 3 4 1 4 9 8067 kPa 1 m 5 ALS 4 1 6 5 50 mL h
26. 42 3 TII 4 2 3 1 2 20 mm min mm 2 1 a 0 55 mm 0 75 mm No b 0 75 mm 10 N 4 2 3 2
27. 6 1 6 2 i JIS T 14971 16 T 2 1 0216002 17 2 16 H 2
28. 3 2 6 6 1 a b c d e f a b
29. 1 16 169 5 JIS T 14971
30. 3 18 MRI _ E 3 a b c 3 19 3 20 3 21 3 22 URAC
31. 3 0310003 17 3 10
32. I VD 1 17 2 16 0216002 2 a ee 3 aS SE EI E A
33. 2 1 3 4 2 5 1 1
34. 3 13 3 14 FP SHR IA ILO BAIR CLE BIC RES SWF FW 3 15 3 16 3 17
35. JIS T 14971 JIS T 14971 4
36. 3 23 3 24 4 4 1 B 4 1 1 X HE ASTMF 640 4 1 2 15 2 13 0213001
37. bb cc dd 20 mL h ee 6 2 2 6 2 2 a b c X d X e g MRI h A A1 ISO 7197 1997 Neurosurgical implants Sterile single use hydrocephalus shunts and components ISO 14630 2008 Non active surgical implants General requirements ISO 1099
38. 3 6 3 7 3 8 l FEE OD ADL EMIDD EEEE b Ll RANEE L aE 3 9 Ome 3 10 3 11 3 12
39. CSF 3 2 RETR FPR OPEC TI ZIET AHIT PARE dB dK PERSIE Re 2 BEY 3 3 34 3 5
40. 16 6 169 5 JIST 14971 iE JIS T 14971 4 1 1 4 1 4 4 1 8 4 1 9 4 1 11 4 2 1 1 4 2 1 2 Ate a
41. 2 20mm min mm 2 1 a 0 55 mm 0 75 mm 5 N b 0 75 mm 10 No 4 2 3 2 2 20 mm min mm 15N 4 2 3 3 4 2 3 1 4 2 3 2 20 N 2
42. 9 8067 kPa 1 m l 4 1 9 140 2 Hz 10 5 N 100 000 o 4 1 10 MRI ASTM F 2503 05 MRI 4 1 11 19 6133 kPa 2 m 10 2 10
43. 2 b 10mm 50mm 500mm 1 a NLT OBE b 63 4 1 3 4 5 6 7 2 5 wk 5 1
44. 2 NR 3 ee ee 4 NN 5
45. GMP QMS 4 4 0330001 17 3 30 4 1 3 7 GMP QMS 4 BESS 4 REE 0330001 17 3 30 A 4 1 3
46. JIS T 14971 4 1 9 4 2 1 2 2 JIS T 14971 4 1 2 SLN 3
47. x 4 2 42 1 gt 4 2 1 1 0 4 9033 kPa 0 500 mm 0 04 mL min 4 2 1 2 5C 20 mL 28 4 2 1 3 4 1 6 422
48. 4 ie 5 Y 6 7
49. 6 7 gt NM 13 2
50. b 1 2 3 4 5 4 4 5 4 1 2 a 10mm 50mm 500mm 1 4 5 4 2
51. 0 0 4903 kPa 0 500 mm h MRI i MRI MI k D m n o p q N s 0 u y w x y 2 aa
52. 2 3 1 0 7 2 3 2011 4 15 ak ME TEL 083 933 3023 FAX 083 933 3029 0 3 318308 2 3 3 3 1 BY 35 145 14 1 19 2 1 14 9 19 2 5
53. 17 2 16 0216002 4 2 17 3 31 0331012 AUS 2 5 7 16 298 1 122 23 3 31 1
54. 7 JIS T 14971 4 1 2 JIST 14971 4 1 2
55. 8 16 l 1695 9 gt 10
56. 5 mL 8 6 9 300 mm 6 7 we 10 1 9 a b 1 3 2 4 1 4 5 4 5 1 4 5 2 37 2 C 4 53 2
57. 3 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 Moist 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 Specifying Implantable Shunt Assemblies for Neurosurgical Application B B 1
58. 4 2 37 2C 4 4 3 1 4 4 4 1 2 3 1 4 5 0 1 6 60 5 mL 10 0 08 kPa N 50 mL 30 mL 20 mL 10 mL
59. JIS T 14971 3 10 2
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