別紙1 [PDFファイル／460KB]
Contents
1. 5 2 6 8 6 12. w a 2 o HG HH 3 17 3 18 MRI
3. 3 5 _3 6 3 7 38
4. 2 20 mm min mm 15 N 4233 423 1 RU 423 2 20 N 4 3 4 3 1
5. T 3 9 3 10 3 11 3 12 3 13 3 14 HLT FW APR EA ILA lt lt ML eA ee 315 3 16
6. 423 II 4 2 3 1 2 20 mm min mm 2 1 a 0 55 mm 0 75 mm SN b 0 75 mm 10N 4 2 3 2
7. 20 N
8. 3 24 PA 4 _4 1 SRA B B 4 1 1 K ASTME 640 4 12 15 2 13 0213001 AET TR
9. c XX d X 9 D BABY CHR STS IRE TORE g 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 device
10. 42 3 1 MBB ORAM HOH COMEPRMSTOLC BCAA DDSCERMAT FILEBRLIEAMIC 2 20mm min mm 2 1 a 0 55 mm 0 75 mm 5 Na b 0 75 mm 10 N 423 2 2 20 mm min mm 15N 4 2 3 3 4 2 3 1 423 2
11. 1 5 454 2 2b 10mm 50mm 500mm 1 5 a b ARR 63 4 1 NEDA oo TP 5 5 1 A2
12. e 5 50 mr fh 2 j 8 10 20 mL RA OAPI 0 0 4903 kPa 0 500 mm h MRI MRI MRI k D m p n
13. 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 C 20 mL 28 STARTERS 4 2 1 3 4 1 6 422
14. 4 1 9 1 0 2 Hz 10 5 N BRIE 100 000 Es ym 4 1 10 MRI ASTM F 2503 05 MRI 4 1 11 19 6133 k Pa 2 m 10 2 10
15. FE 3 a b c 3 19 3 20 3 21 3 22 3 23
16. 44 44 1 4 4 2 37 2 4 43 1 f 444 i 1 2 3 1 4 5 0 6 60 5 mL
17. 10 0 08 kPa 7 50 mL 30 mL 20 mL 10 mL 5 mL 8 ODD 9 300 mm 6 7 3 10 1 9 a D 1 3 2
18. a DRAX b c d e faa a f b oS N 6 2 6 2 1 a b c d
19. 0 p 9 D s ae D u v LoTEL SARC BIT SRS ww x y 2 aa bb LB SIT oa cc dd 20mL h l ee 6 2 2 o ca tak a X o 6 2 2 a b
20. at 1 1 mm 2 3 4 1 7 in vivo X 4 1 8 mes 9 8067 kPa l m
21. 1 1 2 _ 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 Med
22. 4 1 4 5 4 5 1 PST BH CHE LL AER DT CHE BE SS 45 2 37 2C 4 5 3 2a 2 D 2 3 4 5 4 4 5 4 1 l a 10mm 50mm 500mm
23. O Oo O Oo O O O 4 15 jiaasniortarsone o o o o o o o 0 4 1 6 VAT OTE MERE 4 4 4 7 4 4 4 4 1 7 in vivel O A 4 1 8 imete o A A A 4 1 9 naman O O O O 4 1 10 MAURIE cote 2 O O O RE O O O O A JSF HEMEICESTT BBO BM ILO 3 Fa TRUER BONE 4 2 3 HERES 1 SMI CU SAMS B 3 L
24. T OOP T EE ETE E E 4 1 3 i 4 1 4 9 8067 kPa 1 m 5 AA 4 1 5 LAF OPA ik 4 16 5 50 mL h
25. ical 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 5 GMP QMS 4 4 OE RNY l i EIE 0213001 15 2 13 l 3 3 1 BUS WE TALI OME Oe OIC RK CSF 32 RLM ANP REWR OWL CEE HS HMIET OHT PHILA SA ao BER PS NB TORRT ENA PATI FELL A EEL OE RTD bb D ce 3 3 3 4
26. s 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 oe Implantable Shunt Assemblies for Neurosurgical Application B Bl JMDN 16244000 3 HEM stich mpm YIM em Seem BER 41 ERRA O o O Oo Oo O 4 1 1 ENATEBE O a A A A A A 412 O Oo O Oo Oo o o o o 4 1 3 VENEDOR O fe O Oo O 4 1 4 liens
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