薬食発0331第30号
Contents
1. 42. Gees ZAT JIST 14971 3 4
3. 3 23 3 24 4 _4 1 B 4 1 1 gt K
4. a b c e f eee Ea a b 6 2 _ 62 1 a
5. i 0310003 3 10 6 1 6 2 JIS T 14
6. 2 3 METIS CB
7. 3 5 3 6 WERE 3 7 3 8
8. 4 5 P 14 C264 IM 2 RRC ADRS OD SA
9. 3 m lt a NR BEL Ri A 17 2 16 0216002 pee eee 4 2 17 3 31 0331012
10. 3 17 VE 3 18 MRI E OYE 3 a l b BALA OF FUMBLE LIC ES ERORE c 3 19 3 20 KE 3 21 3 22
11. ae 3
12. JIS T 14971 ee a ee a ERAH 0310003 17 3 10 gt Ws 9 o JIS T 14971
13. 2 20mm min mm 2 1 a 0 55 mm 0 75 mm 5 N b 0 75 mm 10 N 423 2 2 20 mm min mm 15N 4 2 3 3 4 2 3 1 4 2 3 2 _ 20 N
14. 3 m 4 RE TUTTE SFR 5 11
15. 4 1 3 16 AEH ME Ts 169 8 lj Him amp LTA 9 10
16. i 169 5 16 JIS T 14971 2 3 O
17. Ofa Web Z JIS T 14971 JIS T 14971 JIS T 14971 e ee E RETE
18. 4 1 2 JIS T 14971 4 1 9 4 2 1 2 JIS T 14971 2 ET SYS 9
19. c X d X RET OE e D WEB ICS CURE S NAAR TT ORR g MRI h A _ 4A 1 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 ste
20. 7 gt 132 _ 2 3
21. hag ao ce ao BEES 2 5 7 16 298 2 1 122 23 3 31 I 1 s a 2 1 3 4 TAa 9 7 2 NCS ARE NEE Hee Cees 5 1
22. TY JIS T 14971 0310003 17 3 10 E 2 _ 3 1
23. 4 5 JIS T 14971 4 1 2
24. _ 16 169 CE 16 169 JIST 14971 5
25. 16 169 Z OGL HH PUR ae AACE HICH T Sm E 16 169 2 3
26. 3 a 4 1 2 JIS T 14971 JIS T 14971 TERR Y A
27. 4 1 9 10 2 Hz 10 5 N PERL 100 000 4 1 10 MRI ASTM F 2503 05 MRI 4 1 11 19 6133 k Pal m 109 2 10 4 2 4 2 1
28. ASTME 640 4 1 2 13 2 13 ARNERI 0213001 TEJA RJE LT JIST 0993 1 YE 4 1 3 4 1 4 807 EP ere EE oer tye Kies 416
29. GMP QMS i 4 4 VFO a VALE ORS 0330001 17 3 30 4 1 3 GMP QMS 4 4 EEE 0330001 17 3 30 7
30. 5 50 mi h 1 1 mm 2 3 b ALT myvivo L pore ee 4 1 8 9 8067 kPa 1 m
31. 1 l 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 ee ERIE FS 0330001
32. 4 5 ERE i EMPELRLT ERR O 6
33. 0 al a Bem LO Reon in ve 4 1 8 EC TR 2 PARED l FBTR PIR
34. m n o p q Y s t u V w O y 2 aa bb DE co i dd 20 mL h ee 6 2 2 APET 6 2 2 a b
35. _ 5 6 l
36. b c d o 5 50 mr MO vane am f 5 10 20 mi 0 0 4903 kPa 0 500 mm REE h MRI i MRI MRI GR Fits k
37. JIS T 14971 6 8
38. 2 a 10mm 50mm 500mm 1 5 454 2 2b 10mm 50mm 500mm
39. 1 5 XY ID ye N N N N N N X 1 N N N S RI N N N N R N SN NSS a ee 1 a b 2 5 5 1 5 2 ine LBM 2 6 RR WRIS 6 1
40. 3 1 4 0 1 6 6045 mL 10 0 08 kPa 50 mt 30 mL 20 mL 10 mi 5 mL 8 6 9 300 mm
41. 3 9 ee ee eee o oa 3 10 e 3 11 3 12 PREZ DS SUS He GETS BIA AEA BERD BAK ZRET SA DOOM RIES 3 13 MEENE FF 3 14 eC AACE a EA ULLE I 3 15 3 16 o
42. II 4 2 3 1 PENER TE E RA IAA 2 20 mm min mm KERT 2 1 a 0 55 mm BLE 0 75 mm 5N b 0 75 mm 10N 4 2 3 2 Pe PE Pa RLA E7 TRETE T Ea 2 20 mm min mm ERRER DNAS J 4 2 3 3 4231 4232 BENT
43. 0 3 3 1 3 0 23 3 31 all Fi l HULL PO tr tant PMMA E 14 9 19 2 5 cae ae 1 VD _ H 1 17 2 16 0216002 2 Fie AMO ARE EMTS AER yY heh oc
44. 4 2 1 1 0 4 9033 kPa 0 500 mm AEO ERENT EEL 0 04 mL min DA 4 2 1 2 AYA MILES CHRO 20 mL 28 l 4 2 1 3 AVAPERBITIS 6 BA ORBALORE 4 1 6 42 2 4 2 3
45. ERRETA Cito CREO 1 5 2 3
46. 4 2 1 3 CL PHEREIREIT SBA ORB LO Agim 422 asusnaonne 1 IT 42 3 1
47. 7 Jy 7 10 1 9 a E SS N N N NS N N Sa AAT A N N P f A re CLT TITTITTTIIITTI TIT INT TN a D 1 3 2 4 1 45 4 5 PVT BYR CT LL FAKE RDF CHE BK SALES 4 5 2 37 2C 4 5 3 Bete 2 2 b 1 D 3 4 5 4 4 5 4 1
48. 8 1 2 BUSTER DURA Ds Wy 2 2 3
49. 3 16 169 JIST 14971 6 i TIST 14971 4 1 1
50. 4 5 6 EGR A IA vV 7 a NB
51. 0 2 JIS T 14971
52. 17 3 30 GMP QMS 4 4 AT SY 0213001 15 2 13 H 3 1 CSF 3 2 RAR MERRER D d EAX E REA 33 3 4 Ui RRR HITT AE Ze EA BS FREE CARER
53. 4 1 4 4 1 8 4 1 9 4 1 11 4 2 1 1 4 2 1 2 POE 7 BPE OTR JIS T 14971 TERR I AR 4 1 2 JIS T 14971
54. 971 16 2 2 1 RAIS 0216002 17 2 16 H HIRR Fe BE b BR
55. HAM DARE SAL SEE SEARO ETRE BHE ERIE E OBA BIS 20 N 4 3 4 3 1 7 4 4 4 4 1 4 4 2 FER 37 2C 4 4 3 1 444 _ 1 2
56. rilization 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 JSO 11070 1998 Sterile single use intravascular catheter introducers ASTM F 647 94 Reapproved 2000 Standard Practice for Evaluating and ae RRA Shunt Assemblies for Neurosurgical Application B Bl JMDN 16244000 aii namaa O O 412 0 413 A14 fie 1 8 1 9 4 1 6 ae 2 4 1 11 EAE NEMERE TOY AT 4 2 4 2
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