各都道府県知事 殿 水頭症治療用シャン ト承認基準の制定について
Contents
1. 0310003 17 3 10 A 6 1 6 2 ER f JIS T 14971 ERRER UZ2. 16 169 5 Opi LURES eA SE 16 169 5 2
3. 1 3 DEEA VEERE 2 Y 3
4. 2 T HATER EER ORIEL DO Ms 3 Rint REO RICA 9 4
5. 4 5 aA
6. 2 20 mm min mm 2 1 i a 0 55 mm 0 75 mm SN b 0 75 mm 10 N 4 2 3 2 ig aa aaa 15 N 42 3 3 4231 4232 SHE LAROR GIMME SLE LAHEL OMA MIS ON OF TEU EDD CREA 4
7. 0310003 SER 17 423A 10 A A 9 DfEE JIS T 14971 JIS T 14971
8. i 6 7 8
9. 3
10. Ce EREET 1 16 169
11. ts 4 1 2 6 JIST 14971 8
12. 1 2 2 3
13. 1 ee f GMP QMS 4 BERS 4 0330001 17 3 30 4 1 3 8 ee 16 169 5 9
14. 2 20 mm min mm 15N 4 2 3 3 4 2 3 1 4 2 3 2 20 N 2
15. 3 16 169 5 9 4 16 169 5
16. 3 II 42 3 1 2 20mm min mm 2 1 a 0 55 mm 0 75 mm 5 N b 0 75 mm 10 N 423 2
17. 10 1 9 a b 1 3 2 4 1 4 5 4 5 1 SVT BR CHT U BOKER ONT CHE BE EES 45 2 37 2C 453 2a 2b 1 2 3 4 5 4 4 5 4 1 2a
18. 4 A 5 6 7
19. 1 1 mm 2 3 4 1 7 in vivo Px X 4 1 8 41 11 RRE 9 8067 kPa 1 m 4 1 9 1 0 2 Hz
20. TY JTS T14971 JIS T 14971 8 i T Wy K JIST 14971 i 0310003 17 3 10 E
21. t m 5 11 SRE 2
22. 3 15 3 16 RARA 3 17 ey YE 3 18 MRI
23. 10 5 N 100 000 i 4 1 10 MRI ASTM F 2503 05 MRI 19 6133 k Pa 2 m KREWE LIMA Te 1096 2 10 i 4 2 4 2 1 4 2 1 1 0 4 9033 kPa 0 500 mm 0 04 mL min
24. nen ated 3 4 5
25. 6 1 a b c D e f a b 6 2 6 2 1 a
26. JIS T 14971 ERES A 4 5 JIS T 14971
27. 3 7 AYA 7 E 3 8 1 kE SLI RH SNES NEE 3 9 3 10 3 11 3 12 3 13 ut RICANS DALI BET ST V 3 14
28. 3 24 4 4 1 a a at SHAM RSEROWREOR RICO THINES BERT 4 1 1 RT HALA X ASTM F 640 4 12 15 2 13 0213001 Be LT JIST 0993 1
29. ae 3 a b c _3 19 3 20 3 21 3 22 RELE SNOBA SODIR ji 3 23
30. JIS T 14971 2 _ 3 1 0
31. 10mm 50mm 500mm 1 5 454 2 2b WHEY 10mm 50mm 500mm 1 3 E 5
32. b o d e 5 50 mL SG R A 5 D me 10 20 mL RA CAMA REE 0 0 4903 kPa 0 500 mm h MRI i MRI ye lt D MRI k D
33. LCOS Bi CHS WRITES Loi 0 USERS JIS T 14971
34. 1 6 2 1 EREE 3 0216002 I7 2 16 B 2
35. 1 4 5 0 1 6 60 5 mL 10 0 08 kPa 7 50 mL 30 mL 20 mL 10 mL 5 mL 8 6 9 300 mm 6 7 2
36. 4 BIEZ KET EARRAN 77 A NESE RARE ONEEN 5 l 1 1 w BIRRE
37. 3 3 7 3 4 3 5 3 6 3
38. m n o p q s D u VEDRE LOTEC o TECCAR ETZE w x y 2 aa bb ce dd 20 mL h ee 6 2 2 6 2 2
39. 2 17 3 31 0331012 2 5 7 sage 16 298 1 122 KOLB RBERLED PLEA 91 1 2 1 3 BRIA BEE PIR
40. 5 f Y a b 6 3 4 1 AIDIN HPL WP Nir 2 5 1 HE WE ETS 5 2 6
41. JIST 14971 TERRE Y 4 1 2 3 IST 14971
42. 4 1 3 ented 4 1 4 9 8067 kPa 1 m KEE ORE 415 4 1 6 5 50 mL h
43. i _ 2 3 17 2 16 0216002
44. JIST 14971 4 1 1 4 1 4 4 1 8 EHRE 4 1 9 BEARER E 4 1 11 4 2 1 1 MES MIRAI CRE MERE 4 2 1 2 7 SPER ORE
45. 6 ap GMPQMS 4 BESS 4 CERES 0330001 17 3 30 4 1 3 7
46. 1 4 TEE TIN RAE RE 2 3
47. JIST14971 BED TEREC ko CRHOBSNSA i 2 JIST14971
48. RORE FR USES L PES JIST14971 5 16 169 5 JIS T 14971 6
49. b c X d X e D BCI v CURIE S75 ERECT SBS 2 MRI h WESA 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 arid routine control of a sterilization process for medical devices ISO 11137 1 2006 Sterilization of health care products Radiation Part 1 Requi
50. 0 3 318308 2 3 3 3 1 35 145 14 1 19 2 1 14 9 19 2 5 1 VD l 1 17 2 16 0216002
51. 421 2 RE 5C 20 mL 28 42 13 BEORBRILOVS 4 1 6 422 4 2 3 Ba C7 FA 4 2 3 1
52. JIST 14971 4 1 2 Z JIS T 14971 4 1 2 WE BAROKKE JIS T14971 pi 4 1 9 4 2 1 2 2
53. 4 5
54. 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 GMP QMS B48 4 SRE 0213001 3 2 13 i 3 3 1 RWS WOGTE ILRI OMB OTe OIA RR CSF 3 2 REST
55. b TER IRVA NEE 1 5 2 3
56. 3 4 3 1 44 4 4 1 f 442 37 2C 4 4 3 1 4 4 4 z 2 3
57. o O O 4 1 3 leno man O o O O O Oo O O Oo 4 1 4 pret O O O O Oo Oo 415 marenko o o o lo Oo o Oo Oo 416 o A A a A 4 A 4 1 7 nvwo fo A 4 1 8 MERE Oo A A A A A A A 4 1 9 beman O o O O o O Oo O 4 1 10 _ MRIRAF TORA 2 O O O oj o Oo fe Oo Oo 4 11 BRE O O o O Oo Q Oo Oo FSM IMS TOY eh AT 4 2 4 4 Paine ge Re A 4 2 1 2 lemme O A 4 2 4 3 leg R o A 4 2 2 F TRU ROE o fe o 4 2 3 Wie xs o 1
58. rements 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 introducets ASTM F 647 94 Reapproved 2000 Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application K B Bl pm JMDN 16244000 T HER EREA ae ace BER 4 4 O o O O Oo o o O o 4ii BARTA O Oo O Aa A a A a A i 4 1 2 oO fe O O Oo O
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