薬事法第2条第5項から第7項までの規定によ り厚生労イ動大臣が指定
Contents
1. 2 ISO 7197 2006 Neurosurgical implants Sterile single use hydrocephalus shunts and components JIS T 0993 1 2005 1 gt 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 3 302. 44 4 4 1 4 4 2 37 2 4 4 3 1 4 4 4 _ D OO 1
3. 1 1 mm 2 BIS 4 7 imvivo X 4 1 8 9 8067 kPa 1 m
4. 3 5 3 6 3 7 Y F 7388 38 BEEZ BILD D METEM LS AEDE LELA YY AYRE 3 9 EE OLED NAR ORS BAA PFE CERT DREE on gt 3 10
5. 1 5 454 2 2b 10mm 50mm 500mm 1 Do 5 a b 15 6 63 4 1 7 1 2 3 4 5 2
6. C 20 mL 28 A CVU AIRES AES RO RA oe ee 4 2 1 3 oS 4 1 6 422 4 2 3 Ht 4 2 3 1 bb dC OBERT oR EC
7. 0 1 60 5 mL 10 0 08 kPa 30 mL 30 mL 20 mL 10 mL S mL 8 6 7 9 300 mm 6 NETHIT De 3 N 4 5 _ 6 N 7 Ne 10
8. GMPQMS 4 4 5 0213001 15 2 13 3 3 1 DUS BE ERRORE OT CAPR CSF 3 2 RAREST PRR ORE CEA HORE Eb Cy ath ERICEIRA HH 33 nen 3 4
9. 3 11 a eae 310 RI Oe RAR EEDS T Ae TS AC fii AINE 2 LOOK BE 3 13 3 14 l ADA ae 2 RAILLART lt MLE AMIR A DTF 3 15 Fy ZANT 3 16
10. OO 2 20 mm min mm 1 2 1 a 0 55 mm 0 75 mm 5 N b JMZ 0 75 mm 10 N 4 2 3 2 WREE 2 20 mm min mm ISN 4233 4231 4232 20 N 4 3 43 1
11. 3 17 3 18 MRI 3 a l b PEE EMKU E EEE LAC k S BAROR c Nee 3 19 3 20 FB HOKE 3 21 3 22
12. 1 9 b reni 1 4 5 4 5 1 4 5 2 37 2C 4 53 2 gt 2 0 0 1 2 3 4 5 4 4 5 4 1 2a 10mm 50mm 500mm
13. 5 5 1 gt 52 6 ER MEXE 6 1 Ge a TRA MI
14. A Al ISO 7197 1997 Neurosurgical implants Sterile single use hydrocephalus shunts and components ISO 14630 2008 Non active surgical implants General requirements ESO 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 contro 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 Hevea catheter introducers ASTM F 647 94 Reapproved 2000 Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
15. REECE SCORER OT 3 23 3 24 4 4 1 B 4 1 1 gt X ASTME 640 4 1 2 15 2 13
16. E 4 1 9 a Lie Y RY RF ADATRA ORTAR HRSS 1 02 Hz CARESS Z L 10 5 N 100 000 rae 4 4 10 MRI NSR OO ASTM F 2503 05 MRI 4 1 11 19 6133 kPa 2 m 10 2 EE OE A 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
17. y wW x y _ aa bb 2 cc dd 20 mL h e 6 2 2 6 2 2 a Dee E ae eee eS eee cc X d X 2 g MRI h
18. 0213001 BL UC JIS T 0993 1 4 1 3 RR ao eae 4 1 4 9 8067 kPa im 5 ALS 2 4 16 5 50 mL h Wo SER OFFA i
19. b c d e D Es a b 6 2 6 2 1 a b c d e 2 5 50 mL
20. Boe D g 10 20 mL 0 0 4903 kPa 0 500 mm NE A h MRI i MRI MRI k D m n o p q s t u
21. BYES 2 5 7 16 298 1 122 23 3 31 1 2 1 3 BERIT EO 4 2 5 fis BEATTIE THERESE DSBL EO aids ADICARA ONTI K 1 1
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