各都道府県知事 殿 厚生労働省医薬食品局
Contents
1. 42. 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 0330093 17 3 30 GMP QMS 4 4
3. 2 3 I 4 2 3 1 2 20mm min mm
4. 3 17 f 3 18 MRI 3 a b o
5. 8 ER
6. i 5 JIS T 14971 4 1 2 6 JIS T 14971
7. 5 TEA 6
8. 16 169 JIS T 14971 TEJ I A
9. 16 169 JIST 14971 5
10. TER tE H pE HE 0310003 17 3 10 A 6 1
11. 2 20 mm min mm 2 1 _ a 0 55 mm 0 75 mm 5 No b 0 75 mm 10 N 4 2 3 2 2 20 mmminmm ISN 4 2 3 3 423 1 42321 CRP SADC SIAR
12. 2 1 E 3 H
13. 10 1 9 f EE a l b 1 3 2 4 4 5 4 5 1 4 5 2 37 2 4 5 3 2 b l 1 2 3 4 5 4 4 5 4 1
14. JIS T 14971 3 16 169 4
15. 3 4 5 is
16. y z RAD A F REST 5 JERU th D EEF BORE Y AY amp 6 7
17. JIS T 14971 E ae JTS T14971 0310003 6 17 3 10 A JIS T 14971 TERA Y x
18. 4 2 17 3 31 0331012 IRS 2 5 7 16 298 1 122 23 3 31
19. 13 2 3
20. 2 U EREEREER ENARA Me RRELA
21. 2 COUNT 4 BERS 4 GMP QMS CER ERE 0330001 17 3 30 4 1 3 7
22. uh z 2 b A R CER I R 23411 3 17 2 16 0216002
23. 4 1 10 MRI ASTM F 2503 05 MRI 4 1 11 19 6133 kPa 2 m E10 2 10 4 2 4 2 1 4 2 1 1 0 4 9033 kPa 0 500 mm 0 04 mL min LA 4 2 1 2
24. 3 5 3 6 3 7 3 8 1 3 9 i E
25. 16 169 JIST 14971 i 6 JIST 14971 4 1 1 4 1 4 4 1 8 4 1 9 4 1 11 4 2 1 1 42 1 2
26. 6 7 8 th RRA AS CORREO 2
27. GMP QMS 4 4 REE 0330001 17 3 30 4 1 3 8 16 169 9 IRAE OEA MAER
28. VW 4 A 5 1 4
29. 6 2 6 2 1 a b o d e 5 50 mL 8 10 20 mL 0 0 4903 kPa 0 500 mm KEE h MRI i MRI LT REI BES RIE
30. 2 1 a 0 55 mm 0 75 mm 5 No b 0 75 mm 10 N 423 2 2 20 mm min mm 15N 423342 3 1 42 3 2 20 N 2 5 zi 3 SRR 1
31. 16 169 5 16 169 5 2 3
32. 0213001 15 2 13 3 3 1 CSF 3 2 PHAR OMER KE a BE 3 3 34
33. JMDN 16244000 MRR rs Ah RREAK e See eR 41 ansa O O O O O O Oo o o 4 1 1 erna O O A A A A A A a2 O Q Oo Oo o o o o o o 4 1 3 wma O O Oo Oo Oo O o O O Oo 4 1 4 ang O O O O O O O O 4 1 5 Oo O O Oo O O O O 0 ALS o 4 4 4 4 A 4 4 4 1 7 Jin vvyoe O A 4 1 8 hieten Oo A 4 1 9 ieman O O 4 1 10 MRI 2 O O O aiii RE o o o CEEE aa O A 4 2 1 2 O A SIVIPERIZESH BBO BR AED 4213 e fe A 4 2 2 O o 4 2 3 amas o 1 x
34. 6 6 1 ROSE a b 0 e f a b
35. 20 N OA CHE 4 3 4 3 1 BRESOREOLEMERA SEMA LCBO T AAMIR MICS 44 4 4 1 4 4 2 37 2 443 1 4 4 4 1 2
36. 2 _ 3 i ERRA NE 1 0 SHEERS SBA SRE OE
37. p 1 5 E 2 3
38. 1 3 a 1 2 3 4 5 6 3 4 1 7 b 2 5 5 1 5 2
39. 3 JTS T 14971 JIST 14971 4
40. 7 BER UTE JIST 14971 4 1 2 JIST 14971 i
41. 1 2 Ws 4 Te 2 AEREO BESTE E 3 BEERS A bE SBR AT AD Ai 4
42. 4 1 2 WE RALORGES JIST 14971 4 1 9 4 2 1 2 2 JIST 14971 ROBE CER MRR OBE 4 1 2
43. 3 19 8 3 20 3 21 3 N N RAKE mu 3 23 l RELER COREXEEET 3 24 4 41
44. 2 10mm 50mm 500mm 1 454 2 2b 10mm 50mm 500mm
45. SABRE TET 3 10 PNET St 3 11 3 12 3 13 BERERE 3 14 6 315 3 16
46. B 4 1 1 X ASTM F 640 412 15 2 13 0213001 JIS T 0993 1 4 13 REDNET 4 1 4
47. 6 2 a JIST 14971 16 2 1 ERRE 0216002 17 2 16 R 2
48. 9 8067 kPa 1 m KEE OES 3 4 1 5 4 1 6 5 50 mL h 1 1 mm
49. 6 2 2 6 2 2 a b c d FER X G e D BORIC CURES SERRE SHE g MRI h A Al ISO 7197 1997 Neurosurgical implants Sterile Ni 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
50. 10 ARIAS RR OS JIST 14971 TI 0310003 J 17
51. 2 3 4
52. 5 11 2
53. MRI k OHA D m n o p q s TOR 1 u y Ww x 7 2 aa bb cc dd 20 mL h ee
54. 1 2 1 3 4 2 l 5 1 1
55. 2 3 B 4 17 in vivo X 4 1 8 9 8067 kPa m 4 1 9 0 2 Hz 10 5 N 100 000
56. 3C 20 mL 28 Ti 421 3 4 1 6 422 423 IL Im 4 23 1
57. 3 1 4 5 0 6 6025 mL 10 0 08 kPa 50 mL 30 mL 20 mL 10 mL 5 mL i 8 6 7 9 300 mm 6 7
58. 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 5 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 ene Implantable Shunt Assemblies for Neurosurgical Application B Bl
59. 3 10 A J 9 7 JTS T 14971 Z JIST 14971 JIS T14971
60. RHO 3 3 1 3 0 2 8 3 3 1 35 145 14 1 19 2 1 14 9 19 2 5 VD 1 17 2 16 0216002
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