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1. 3 17 3 18 MRI 3 a b c2. 3 5 3 6 3 7 3 8 FB RAL BALD DME EEMI LS REDEE ELECTA V VY RE
3. 6 2 6 2 1 a b c d e 5 50 mL f g 10 20 mL 0
4. X ASTMF 640 4 1 2 15 2 13 0213001 Ble LT JIS T 0993 1 4 1 3 4 1 4 9 8067 kPa 1 m 5 4 1
5. GMP QMS 4 4 OE REDS 0213001 15 2 13 3 3 1 CSF 3 2 REKEDT 3 3 BA
6. 4 4 4 4 1 442 37 2 C 4 4 3 1 44 4 _ 1 EE OE EE SSAC ae aes 3 1 4 5 0 1 6 60 5 mL 10
7. 5 2 6 6 1 a b c d e f a b
8. 4 1 7 invivo X 4 1 8 E 9 8067 kPa 1 m 4 1 9 110 2 Hz 10 5 N 100 000 4 1 10 MRI
9. 2 41 6 422 4 2 3 L 4 2 3 1 oo 2 20 mm min mm
10. 2 1 a 0 55 mm 0 75 mm 5 N b 0 75 mm 10N 4 2 3 2 AFE 2 20 mmmin mm 15 N 4 23 3 4 2 3 1 RU 4 2 3 2 20 N 4 3 4 3 1 Oe CS EON Cee
11. 454 2 2b 10mm 50mm 500mm 1 OMB s a b 2 5 5 1
12. bb cc dd 20 mL h ec 6 2 2 6 2 2 E a b c XX d X e D g MRI h A A l 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 Biolog
13. 3 9 Oak 3 10 3 11 3 12 3 13 n ARRE BEM STS k BENKE A RIC BET SFP 3 14 3 15 3 16
14. 0 08 kPa 7 50 mL 30 mL 20 mL 10 mL S mL 8 6 9 300 mm 6 TE CHAT Ta N 10 1 9 a b 1 beke 12 4 g 1 4 5 4 5 1 4 5 2
15. 1 ISO 7 197 2006 Neurosurgical implants Sterile single use hydrocephalus shunts and components JIS T 0993 1 2005 1 ASTIM 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
16. 3 19 3 20 3 21 3 22 5 3 23 3 24 4 _4 1 B 4 1 1
17. ASTM F 2503 05 MRI 4 1 11 19 6133 kPa 2 m 10 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 C 20 mL 28 Banco stih 4 2 1 3
18. 37 2 4 53 7 2 2 b 1 TAS ER 3 4 5 4 4 5 4 1 l 2 a 10mm 50mm 500mm 1
19. 0 4903 kPa 0 500 mm h MRI i MRI j MRI k D m n o p q N s D u y ww x y _ aa
20. 5 4 1 6 5 50 mL h 1 1 mm 2 3
21. BUS 2 5 7 16 298 FADER 1 122 23 3 31 1 2 1 3 BEINE KO RIZE 2 hae 4 l 2 5 1
22. ical 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 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 Specifying Implantable Shunt Assemblies for Neurosurgical Application
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