水頭症治療用シャント承認基準の制定について
Contents
1.2. GMP QMS 4 4 0330001 17 3 30 4 1 3 8
3. T TEM 3 2 E 4
4. 2 3 4 A
5. 16 169 5 16 169 2
6. 2 3
7. 5 2 6 6 1 a
8. 0310003 17 3 10 iting gt J 9 ERMC ROSS _ i JIS T 14971
9. 16 169 4 16 169 JIST 14971
10. 5 1 4 2
11. 3 23 3 24 gt 4 4 1 B 4 1 1 HIIRTE HEL X
12. 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 42 3 3 423 1 4 23 2
13. JIS T 14971 4 1 2 3 3
14. 3
15. 0310003 F ER 17 3 10 A 6 1 6 2 gt JIS T 14971 16 W 2 1 GRR 0216002 17 2 16 A 2
16. z 4 1 6 422 423 I 4 2 3 1 MR mee 2 20 mm min mm
17. 3 4 i 7a ERNI RA BEARS 5
18. JIST 14971 4 1 2 JIST 14971 TEJE U A 4 1 2 JIST14971 4 1 9 4 2 1 2 2
19. 44 4 4 1 4 4 2 37 2C 4 43 1 444 _ 1 2 3 1 4 5 0
20. x 3 3 7 3 4 3 5
21. 6 7 13
22. 4 l 2 5 1 1 IORI KRENARE BACAR L BEEN E V BRNE RE gt pig LCA 2
23. X 4 1 8 9 8067 kPa 1 m 4 1 9 ee od 1 0 2 Hz 10 5 N 100 000 4 1 10 MRI ASTM F 2503 05 MRI 4 1 11 WARE 19 61
24. ISO 7197 2006 Neurosurgical implants Sterile single use hydrocephalus shunts and components 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 Devices and Other Items for Safety in the Magnetic Resonance Environment RRRA 0330001 17 3 A 30 A MIRO UPd oA ERED ep GMP QMS 4 4 0213001 15 2 13 3 3 1 CSF 3 2 BEET i
25. i 5 JIST 14971 DRE 4 1 2 6 JIS T 14971
26. 5 16 169 5 JIST 14971 j 6
27. 3 iE ERRED o TREO ERORE BEE PBA ICIRD BEDEL 1 5 2
28. 0310003 SER 17 43 10 E JTS T14971 i 2 RRL BORE CLL 3
29. 8 REDON E RRA TS Bae 1 2 2
30. Z RREK Ets JIS T 14971 3
31. coy 4 Ri 5 T 11 2
32. TER 5 6 2 TER SHANA RT Oe 7
33. 3 17 3 18 MRI YE 3 a b c 3 19 3 20 EBI SRK 3 21 3 22
34. 1 oy Thi 3 9 4 5 4 2 2b 10mm 50mm 500mm 12 5 ee CAS a l b 6 3 4 1 lw i 2 5 5 1
35. 4 ATF TE 5 OEE SAV CV RITTER RV
36. JIS T 14971 JIS T 14971 8 4
37. 4 1 6 7 5 50 mL h 1 1 mm 2 3 4 1 7 mvivo
38. 6 MD 4 4 GMP QMS CREE 0330001 7 3 30 41 3 7
39. JIS T 14971 JIST 14971 JIS T 14971 E i JIS T 14971
40. 2 17 3 31 0331012 BUS 2 5 7 16 298 1 122 23 3 31 1 i 2 1 3
41. ASTMF 640 4 1 2 15 2 13 0213001 JIST0993 1 4 1 3 EOE ETT S 4 1 4 5 f 9 8067 kPa 1 m 5 415
42. 2 Ni ART BLS HEH STEO MES th O HURVNCOVT 3 HH A 3 17 2 16 0216002 4
43. MEIC BET Sa 16 f 169 5 9 DAL 6 10 JIS T 14971
44. 20 N 2 LA WAO 1 16 169 E JIST 14971
45. 3 6 3 7 3 8 l 3 9 j 3 10 3 11
46. 35 0 3 3 1 3 0 2 3 3 3 1 145 14 1 19 2 1 14 9 19 2 5 1 VD 1 17 2 16 0216002 5
47. o 4 2 1 3 ge ORR O O 4 2 3 imRaxs 3 4 2 3 1
48. 2 1 a 0 55 mm 0 75 mm 5 N b 0 75 mm 10N 4 2 3 2 2 20 mm min mm 15N 4233 423 1 RU 4 23 2 ETE N I 20 N j 4 3 43 1
49. b 1 3 2 4 4 5 4 5 1 i PNT EHR OTe LL PEZI TAEAE Et 4 5 2 BERK r 37 2 4 53 2a 2 1 2 3 4 5 4 454 1 l i WT OR MICS D NTH 2 a ORT KICK A FeV UIC 10mm 50mm 500mm
50. i 10 2 TERA OREW RAREN 3
51. 1 6 60 5 mL 10 0 08 kPa 50 mL ARR 30 mL 20 mL 10 mL 5 mL 8 6 7 9 300 mm 6 NETET Die 10 1 9 a
52. b 9 d d 8 i b 6 2 6 2 1 a b c d e
53. 5 50 mL ay 8 10 20 mL 0 0 4903 kPa 0 500mm AEE h MRI i MRI RARE RE i MRI k OHA D m n o p q
54. JIST 14971 4 1 1 4 1 4 4 1 8 4 1 9 4 1 11 ARE 4 2 1 1 4 2 1 2 S E DHRU OR 7 H
55. Y s D u y w x y 2 aa bb KEDEDE VIDERI IT ce dd 20 mLh ec 6 2 2 O 6 2 2 g b Cc 9
56. 3 12 3 13 3 14 3 15 3 16
57. XX RK EAT BES 9 8 MRI h A Al 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 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 car
58. 2 3 BEAN
59. 33 kPa 2 m 10 2 10 Pe 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 20 mL 28 4 2 1 3
60. e products Radiation Part 3 Guidance on gS IIe aspects ISO 11070 1998 Sterile single use iravascilar catheter introducers ASTM F 647 94 Reapproved 2000 Standard Practice for Evaluating and pas Implantable Shunt Assemblies for Neurosurgical Application B Bl RE JMDN 16244000 ERFA AE E aaa P EEE 41 Jensa O O O Oo Oo O 4 1 1 O Oo O A A A A A A 4 1 2 ememmate O O Oo Oo O O O O 413 aetori O fe O O o o O fe O 4 1 4 enact o o O O O fe Oo a15 9 o o Oo O Oo o Oo Oo Ta cor ll valle casi b a aA 4 1 7 jin vwe O A 4 1 8 O A A 4 1 9 na O O o MRI 2 O oO O RE
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