呂り添 水頭症治療用シャン ト承認基準 - 薬事シ去第2条第5項から第7項
Contents
1. PACD YC ERE 0310003 17 3 10 6 1 6 22. Blk
3. 5 OR gt 6 he EROw RATS i
4. ee p 16 169 JIST 14971
5. 2 20 mm min mm 2 1 a 0 55 mm 0 75 mm SN b 0 75 mm 10 N 4 23 2 a a 2 20 mm min mm ISN 4233 4231 804232 CREP SMALL SENER 20 N
6. LORD ORL MATTEL ERLE 10 9 _
7. BASEL 1 5 2 _ gt 3
8. a e AE oe 454 2 l 2b WHEY 10mm 50mm 500mm 1 5 a b 6 3 4 1 2
9. BLL 1 mm 2 3 4 17 jnvivo A ES 4 1 8 9 8067 kPa 1 m 4 1 9 VLR YATADET Off ih O SA a Bee SE LHRH 140 2 Hz HH
10. JIS T 14971 an i i JISTI TERRI Z PIS OUYC 0310003 17 3 10 TIS T 14971 BEGG OMAR
11. 3 4 5
12. O EE 3 o 4 5 eran hee
13. 35 DE L AMR O RW E BHT OOO be BACALL FF RURAL FOF IC sets pin BCES 3 6 E 3 7 3 8 Ee OSL EML POMMEREN b Ll IRE OWI REL AECA Yy RY RS 3 9 NLD OEE GRE ORI Mee
14. 3 2 10 m eo JIST 14971 JIS T 14971
15. JIST 14971 A yy a PR IE AREAS OPERE RR OBE 3 4
16. GMP QMS 4 4 IRS SES 0213001 15 2 13 3 1 CSEF 2 BRL AN AP RERORE VED EMET BNSC FARRER D D OMER LE I BR HE 3 3 ode 5 3 4 l EMO CEN FET SL AL LT RETENO VE HB CPR
17. 0310003 17 3 10 A JIS T 14971 A CLEFT BaD E 2 T
18. 8 i 16 169 5 Z OVER MIRE ARNE 3 16 169 5 2 OT bebe a
19. 4 13 4 1 4 9 8067 kPa 1 m KEDEZ 7 41 5 TOTE 4 1 6 S 50 mL h
20. 10 1 9 a D RF 1 4 5 4 5 1 45 2 37 2 453 2 4 b 1 OO ie ke ee es ea 3 4 5 4 4 5 4 1 2 10mm 50mm 500mm
21. JIS T 14971 a 4 1 2 a i 3 SN JIS T 14971
22. aa a alae 2 3
23. RRO EAE HAE GMP QMS 4 4 0330001 17 3 30 TREAT TBR A Y Lh 4 1 3 Tonic bk CHESS DIOS CORE Eo 8 H H 9
24. 3 24 4 _4 1 B 4 1 1 X ASTM F 640 4 1 2 15 2 13 0213001 BE LC SIS 0993 1
25. 5 20 mL 28 4 2 1 3 4 1 6 42 2 4 2 3 4 2 3 1
26. 16 Ys a BH GMP QMS 4 4 GRAS 0330001 17 3 30 4 1 3 169 JIS T 14971 i
27. 3 17 YORI AT NAIA A DRONE VE CTO te ERRE EN E 3 18 MRI RS gene ayaa NAN Beas 3 l Ea an een ee ee ae b c 3 19 AG 3 20 a PVT 3 21 3 22 O ENDED ASCH SARE O 3 23
28. 8 Te et Ee MRR 1 2 lea 2
29. NN amp gt 7 gt 1 3 2
30. A RUE JERE on oe i cee JIS T 14971 ERR _ E 4 5
31. 3 4 5 A ETE PERTTI 6
32. 16 169 5 16 169 JIS T 14971 CER 16 169 5 JIS T 14971 JIST 14971 4 1 1 4 1 4 4 1 8 4 1 9 4 1 11 WAJE 4 2 1 1 7
33. g 10 20 mL 0 0 4903 kPa 0 500 mm h MRI i MRI MRI k aa Res D m n o p q s t u y w
34. 10 5 N 100 000 ee ORR VY UO BERGA bRO 4 1 10 MRI ASTM F 2503 05 MRI 4 1 11 19 6133 k Pa 2 m 1096 2 10 x 4 2 4 2 1 4 2 1 1 0 4 9033 kPa 0 500 mm EEE FH Ama 0 04 mL min 4 2 1 2
35. 3 11 3 12 APRA DS 2 VET iT A Bt CHAR EHEC ZARET SR OOM BLE 3 13 _ AMAPREIRA BEL HO L BINAE EER PIC Bet AFT Fy 3 14 l RA BRYA 3 19 3 16
36. 5 at a 6 1 soa
37. oo x y aa bb gt cc dd 20 mL h ee 6 2 2 6 2 2 a b c X d X ec f g MRI
38. 1 5 0 1 6 60 3 mL 10 0 08 kPa 7 S0 mL 30 mL 20 mL 10 mL 5 mL 8 ODD 7 9 300 mm 7 Da Maer
39. E 2 FETERE EAL CUSBAlS FTE CHS 3 4231 2
40. 14 2 A 3
41. E bo 3 4 l
42. e f a b 2 621 ay 5 c d DP AD BRAT amp e 5 50 mL D
43. l JIS T 14971
44. 4 3 4 3 1 44 4 4 1 4 4 2 37 2 4 4 3 1 4 4 4 _ 1 2 RECRRRE DED LDL TARIE 3
45. h A A 1 ESO 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 Requitements 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 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 produi 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 Asse
46. 4 5 6 7
47. RUER UTNE JIST 14971 H i KEER rv RGR 4 1 2 JIST 14971 4 1 2 DUE IER ORAES FIST 14971 TER U R SE 41 9 4 2 1 2 2
48. JIS T 14971 Og ea SEEMS r v HARRIE 4 1 2 6 Wwe EMR CO JIS T 14971 Z PN 8
49. 5 5 1 52 ROTC CORRELL RATER REN 6 ER MEXE 6 1 a b c d
50. 20mm min mm 2 1 a 0 55 mm 0 75 mm SN b IME 0 75 mm 10 No 423 2 2 20 mm min mm 15N 2 x 423 3 42 3 1 4 2 3 2 20 N 2 1
51. 4 CORBI KEEDA A RICAN AEL BRASIL 0 RIZE amp cA 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 0330001 17 3 30 A
52. BUYS _ 2 5 7 16 298 1 122 23 3 31 1 2 1 3 BRC E 4 7 2 5 1
53. mblies for Neurosurgical Application B Bl 2 1 1 BAM RAIS SSL vb AF ween Ls BATE RE fp gt rs J p M Ha x it i RE A J N N iw 1 ges 2 Fa DRUERR OBE WHA 3 J gt N iat athe JMDN 16244000 l N ON e la alee AA ice Cet opi a1 aman 0 2 26 IS 6 OO EG So le ait jeweraae Oo o o a aJaja ala 412 OO One CO KO Oz 4 1 3 panonn 8 2 1 2 od o oe a OO 02 OO 6 Pe oe fs ets lt tet 9 Eee229 of a ff 4 1 8 HEEE ola ee ee ee ee 4 1 9 _ movers OL OL 6 0 2 4 1 10 MRRNFTORM 2 mo OS 6 Oo 4 eRe EN ES OO 0 ul Oo cs hs i 1
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