平成2 3年3月 3 ー 日
Contents
1. 2 3 IL 4 2 312. 4 TEV Ly 5 JIS T 14971
3. Sd SAIC fe BB S ae
4. 16 169 16 169 2
5. ERIE 0310003 17 3 10 A 6 1 6 2 JST14971
6. 2 3 SHEE 4
7. 4 1 2 6 JIS T 14971 8
8. 4 1 2 3 JIS T 14971 JIST 14971
9. 3 3
10. 16 169 JIST 14971 6 JIST 14971 4 1 1
11. Z JIS T 14971 ERREI AR JIS T 14971 JTS T 14971 E
12. 3 17 TE 3 18 MRI PES 3 BRERA S a b c 3 19
13. 4 1 2 JIST 14971 4 1 9 4 2 1 2 2 JJS T 14971
14. 4 5 6
15. 13 2 3
16. X ASTMF 640 4 1 2 15 2 13 0213001 ROMS JIS T 0993 1 4 13 4 1 4 9 8067 kPa 1 m 5
17. 5 6 SN 7
18. 16 2 1 EARE 0216002 17 2 16 A 2
19. 2 JIS T 14971 3
20. 2 20 mm min mm 2 1 a 0 55 mm 0 75 mm 5 N b 0 75 mm 10N 423 2 2 20 mm min mm 15 N 4 2 3 3 4 2 3 1 4 2 3 2
21. 2 ISO 7197 2006 Neurosurgical implants Sterile single use hydrocephalus shunts and components JIST 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 Devices and Other Items for Safety in the Magnetic Resonance Environment 0330001 17 3 30 A GMP QMS 4 4
22. 2 17 3 31 0331012 s BUGS 2 5 7 16 298 1 122 23 3 31 1
23. 3 1 0 2 NO
24. 6 E GMP QMS 4 4 CRATE
25. 6 2 6 2 1 a b c d e 5 50 mL A D 10 20 mL 0 0 4903 kPa 0 500 mm KEE h MRI 1 BR yy bY AF AO MRI
26. 2 3
27. 3 10 3 11 3 12 IRD SVS AAT BANC ERD DEER BERETS fe DOW RISE 3 13 l PGE SET Sx LE AOI DARI RES 5 HFF 3 14 315 3 16
28. 6 6 1 3 b c d e fh a b
29. 4 i 5
30. FRARI EEH 3 4 PAR 5
31. 1 5 H 2 3
32. JMDN 16244000 HAR aA Bih 1 ree See 4 1 ensa O fe o o o O Oo o O O 4 1 1 O O O A a 4 1 2 einen ete O O Oo O Oo Oo Oo O O Oo 4 1 3 O O O O o Oo O O O 4 1 4 RhE O Oo O O Oo Oo Oo O ais asenteissa O o o o o o o o L t16 LAAT AOR HREH o a a S A 4 1 7 in vivo Oo A 4 1 8 Ete O A A A A A A 4 1 9 O o o o o fe 4 1 10 MRIS FEDRA 2 O O O O O O O 4 1 11 BRE o o o O o TG 40 WECM RRIMET SY YRT 42 14 ieee o A 4 2 1 2 fe A MLTR SBR ORB EO 4 2 1 3 p o A 4 2 2 O O 0 O 4 2 3 O 1
33. JIS T 14971 ER A 0310003 17 3 10 A 9 JIST 14971
34. PER 7 as 8 1 2
35. 2 i 3 Zl z 17 2 16 0216002
36. 3 5 3 6 3 7 3 8 3 9
37. 4 A 5 Ife 1 4
38. MRI O D m n o p Y s 1 u vV w x y 2 aa bb
39. 16 169 4 16 169 JIS T 14971 5
40. 2 1 3 4 2 5 1 1
41. 2 a 10mm 50mm 500mm 1 5 454 2 2b
42. AN A JIS T 14971 0310003 17 3 10 A o E JIS T 14971 2
43. 2 20mm min mm 2 1 a 0 55 mm 0 75 mm 5 No b 0 75 mm 10 No 423 2 2 20 mm min mm 15N 4233 4231 423 2 20 N 2 EE
44. 4 1 5 416 5 50 mL h 1 1 mm 2
45. 4 4 REE 0330001 17 3 30 4 1 3 8 16 169 5 9 1 0 hh b
46. easly 3 1 4 5 0 1 6 OOLS mL 10 0 08 kPa 7 0 mL 30 mL 20 mL 10 mL 5 mL 8 6 7 D
47. pe OE T 1 16 169 JIST 14971 BO
48. 20 mL 28 4 2 1 3 E at ry 4 1 6 422 PMT OES RET 42 3 L ime 4 23 1
49. 0213001 15 2 13 A 3 3 1 CSF 3 2 3 3 34
50. 4 1 10 MRI MRI ASTM F 2503 05 4 1 11 RJE 4 2 4 2 1 19 6133 k Pa 2 m 10 2 10 EA 4 2 1 1 0 4 9033 kPa 0 500 mm 0 04 mL min 4 2 1 2 1 C
51. 11 2 3
52. 3 4 17 mvivo X 4 1 8 9 8067 kPa 1 m 4 1 9 ty 140 2 Hz 10 kn 5 N 100 000 o
53. 3 20 3 21 3 22 EY 3 23 nb 3 24 4 4 1 B 4 1 1
54. 10mm 50mm 500mm 1 5 a b F 6 3 4 1 i oN 2 5 5 1 5 2
55. 20 N 4 3 43 1 4 4 FE H 4 4 1 44 2 BERT 37 2C 443 1 EJE 2
56. 300 mm 6 7 10 1 9 a b 1 3 2 14 1 45 4 5 1 4 5 2 37 2C 453 2 2 2 b 1 2 3 4 5 4 4 5 4 1 2
57. 0330001 7 3 30 4 1 3 7 _ GMP QMS
58. 4 1 4 4 1 8 4 1 9 4 1 11 WEEE 4 2 1 1 4 2 1 2 7 JIS T 14971 4 1 2 JIS T 14971
59. 0 3 3 1 8 0 2 3 3 3 1 35 145 14 1 19 2 1 14 9 19 2 5 I VD fai 1 17 2 16 0216002
60. cc dd 20 mL h ee 6 22 2 6 2 2 a b c X d X e D g MRI h A AT 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 healt
61. h 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 HEB Bl
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