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23033130(PDF文書)

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3. 2 TSO 7 197 2006 Neurosurgical implants Sterile single use hydrocephalus shunts and components JES 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 0330001 17 3 30 A
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5. JTS T 14971 4 AV a Hi MORE RITE
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9. 3 5 BEY LIBERO Me SET SO Le ACU FTIR ORAL FF ICEL OC 3 6 3 7 3 8
10. BE bat 1 5 2
11. 6 EMRE RT ORE 7 CHV 8 EREK
12. GMP QMS 4 4 GRRE 0330001 17 3 30 4 1 3 8 16 169 9
13. i HONE TINY SEE CE 3 4 5 WIC RA CHOON BARKU
14. 5 2 6 6 1 a b 0 d e f a
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18. 4 1 9 4 2 1 2 2 JIS 1 14971 PERDAS 5 4 1 2 3 JIS T 14971
19. l 10 fICKXIBACELDS BERUR JIS T 14971 ER x
20. 0310003 17 3 10 A 6 1 6 2 k JIST 14971 16 2 1 GEAR 0216002 17 2 16 A 2
21. 5 gt 11 OMUR k JRR MERUN 2
22. 6 NE CHT 9 300 mm 10 1 9 a b 1 3 2 4 4 5 4 5 1 1 4 5 2 37 2C 4 5 3 2 a
23. x 2 3 4
24. TEA 5 i 6
25. GMP QMS 4 4 ERREI 0213001 15 2 13 3 3 1 CSF 3 2 PORT RR OREVED ZIET A BRIT PARR D gt 5 yt BKK IE NIP RHE 3 3 3 4 FRR ORE CEA BEET OO Le AWE LIREN AE KEET ERE
26. 5 JIS T 14971 ERRIZ 4 1 2 6 JIS T 14971
27. JIS T14971 2 JIS T 14971
28. 7 13 RB BWER TEE 2
29. mu GMP QMS 4 4 CREE 0330001 17 3 30 4 1 3 7
30. 2b 10mm 50mm 500mm 1 5 5 5 1 a b 6 3 4 1 wl Rw 2 P
31. E iF SI m Av d vs 8 16 169 43
32. 8 10 20 mL 0 0 4903 kPa 0 500 mm WEEE h MRI REC E A jE ORKE MRI D MRI 5 OHA D m n o p s t
33. C 20 mL 28 4 2 1 3 4 1 6 4 22 4 2 3 I
34. B 4 1 1 X ASTMF 640 4 12 2 15 2 13 0213001 GA JIST 0993 1 4 1 3
35. 3 19 3 20 BISRE 3 21 te 3 22 Fi 3 23 i fa Cut 3 24 bu 4 4 1 i
36. 1 1 mm 2 3 4 1 7 in vivo FRILL T OPER URNOA MERITS CLM CREO L SVT ORBIT BOC 4 1 8 9 8067 kPa1 m ABE OER BI TEL 4 1 9 VLR YAF DOSE TC OPER O Bh EER IHR BPR 140 2 Hz 10 5 N
37. 17 2 16 0216002 4 2 17 3 31 3803310125 B BUGS 2 5 7 16 298 1 122
38. 7 se NR Dy ae JIST 14971 4 1 2 JTS T 14971 PRR 8 3 4 1 2 JIS T 14971
39. v y 2 cB oe ES z ae 3 EOS ay i
40. I 6 JIST 14971 4 1 1 4 1 4 4 1 8 4 1 9 4 1 11 WERE 4 2 1 1 42 1 2
41. 23 3 31 1 2 1 3 4 2 5 1 1 Obie
42. 3 4 A 5
43. VAT DOH is FBR Ce 3 17 3 18 MRI EE 3 Be a MEKA b c
44. 100 000 5 4 1 10 MRI ASTM F 2503 05 MRI 4 1 11 WERE 19 6133 k Pa 2 m 10 2 10 i 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
45. 416 SRT AOR MEE o 4 A 4 4 A 4 4 4 1 7 in vivo A 4 1 8 iEn O A A A A A A A 4 1 9 nesa O Oo o o O Oo Oo 4 1 10 MR 2 O O O fe O O Oo O O 4 1 11 ERE O O O O O Oo O ie f AMBRE AT SY YY AF k A 4 2 1 1 Raga O A 4 2 1 2 enze O 4 2 1 3 eC SB ORME IO o i 213 Seg 2 4 2 2 O Oo O o o O O 4 2 3 MERS O 1 EARTHS 2
46. 4 1 4 9 8067 kPa 1 m 5 4 1 5 l 416 S 50 mL h
47. 234 11 03 3 1 3 0 2 3 3 3 1 35 145 14 1 19 2 1 14 9 19 2 5 1 ff I VD 17 2 16 0216002
48. 3 9 3 10 3 11 a a E 3 12 EDATS NOAE E bR ERAT SE OOM RAE 3 13 3 14 RAL TF AAPOR REAREN DLS BAS 315 3 16 th
49. 4 2 3 1 2 20 mm min mm 2 1 a 0 55 mm 0 75 mm 5 N b 0 75 mm 10 N 4 2 3 2 2
50. 169 ROPERS BEX DEES JIST 14971 ia 5 16 169 2 JIST 14971
51. 20 mm min mm 15N 4233 423 1 RU 423 2 20 N 2 URRE tee iSO ERON ED 1 16 169 5
52. e D D 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 i ISO 11137 3 2006 Sterilization of health c
53. GERAH 0310003 17 3 10 A J 9 LHESDHIRE JTS T 14971 a gt RASC Pill ABE DOR E E
54. 2 1 2 3 4 5 4 4 5 4 1 2 4 10mm 50mm 500 mm 1 5 4 54 2
55. bd v _ E 6 2 6 2 1 a b c D 9 5 50 mL fh
56. 20 mm min mm 15 N 423 3 423 1 423 2 20 N 4 3 4 3 1 4A 4 4 1 44 2 37 2C 44 3 Mice h
57. 2 RUE oii JIST 14971 TERRI A JIS T 14971 JIS T 14971 JIS T 14971 ROTA S
58. 3 42 3 1 2 20mm min mm 2 1 a 0 55 mm 0 75 mm 5 No b 0 75 mm 10 No 423 2 2
59. u vV w x y aa 2 bb cc dd 20 mLh ce 6 2 2 6 2 2 a D c X d X
60. RO RAE 0310003 17 3 10 JIS T 14971 3 10
61. are 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 aa Implantable Shunt Assemblies for Neurosurgical Application B B1 3 AR JMDN 16244000 i MR Ga t 1 YP oe ace See 4 1 o o O O O O O O O O 4 11 O O O A A A A A A 4 1 2 O O O O O O O O O 4 1 3 O O O O O O O O Oo O 4 1 4 ER O O O O O O O O 4 1 5 O 0 0 O O Q O O GO
62. o PRR Ekint Ason 444 i 1 2 3 1 4 5 0 1 6 6045 mL 10 0 08 kPa 7 50 mL 30 mL 20 mL 10 mL 5 mL

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