薬食鵬ー 2 0~3第ー号 - 医療機器基準等情報提供ホームページ
Contents
1. 6 169 JIS T 14971 22. w A BEWEIS EDI 7e ROBUR TROCUCRCSURRUT
3. 15 2
4. GMP QMS GERE 0330001 S 17 3 30 4 5 WR ooo 7 RPER URR Ordo
5. 2 3
6. 5 n TE THA m PEREDUR 6 BEER CH SNERI PERSEE
7. o Z GRNORED EAE in Tp of ERR Ln i JIS T 14971
8. 12 2
9. 4 1 1 1 42 15 2 13 BRE EE REERERE SE 0213001 JIS T 09
10. Y JIS T 14971 A 9
11. 16 169 6 10 6
12. GMP QMS 0330001 17 3 30 4 XC 538 8 RIGER 169 9 GREE
13. i 14 M o
14. 3 A CEMER BERR 0310003 17 3 10
15. 16 169 JIST 14971 Eo s 36 oxi 5 ESMSRROGUMDEUDEGE 16 SRE MERU 169 2 JIST 14971 UE 6
16. 3 2 4 Q amp A 3 Q amp A 1 1 1 1 1 1 ASTM F1264 Standard Specification and Test Methods for Intramedullary Fixation Devices 15 2 13 0213001 i 1 2 2 JIS T0993 1 1 2 3 ISO 10993 1 18 Biological evaluation of medical devices part1 18 13 1 3 4 ASTM F67 Standard Specif
17. 4 2 TR EE BERUR ES 4 3 2 HIST 14971 AF Sd ESI E 8b
18. 7 13 x
19. Q2 20 10 8 1008001 1008001 A2 1008001 1 4 3 Q3 4 3 3 A3 ASTM F 1264 FDA 25 AS
20. 4 5 11 ES
21. 5 JIS T 14971 L 6 JTS T 14971
22. VN w v 4 5
23. ISO 10993 7 10 3 31 353 53 5 3 1 6 5 32 6 1 62 17 3 31 0331008 20 3 28 0328003
24. 3 4 5 6
25. uu eu l 2 EIUS TEVSIEIZEBREVASTSRERUUY F7 1 2 5 7 16 298 1 1 2 S91 JMDN
26. E SA PR BRUE L OS ORE JST 14971 As 4
27. co JIST14971 JST1I497 JIS T 14971 JIS T 14971 E
28. Q5 A5 Q6 A6 2 4 Q7 1
29. 3 FERIER 169 4
30. amp EE i CAREI BARES Sao ME 6 IST14971 16 0216002 5 17 2 16 2 1 2
31. 4 3 1 4 ASTM F 1264 4 43 2 j ASTMF 1264 4 3 3 ASTM F 1264 4 3 4 43 17 43 3 S 5 1 5 SAL 10 52
32. JIS T 14971 S6 2 Jus 3 em 10
33. AT
34. JIST 14971 4 7 BERUHEN BA JIST 14971 Z
35. 2 3 2 3 1 2 32 2 4 2 4 1 242 243 SS
36. 2 200 0 GERRHE T teori REBORE GEMBRE DV BIA ESROS MERER OET Bd ERERURZE ENERO BIOS STREETS EURO UMEN b 588 IIR 5 CATIRRORESHDERS Thb DRREE GENRERNA WDR UMEN 515 KOGSESIEU CES im ESHHEROTEAMENURDOR CFR 16 TERMAS B108 I TOUR MUERE A dv Ce BENDRE XBASL SEG TRESR OG Beca MEETS k E WA HGURB EST OHUSS ERREN UR E BUEIBIS Re ED ROBES US RARO 16 169 8
37. 3 4
38. 17 3 10 0310001 17 3 10 0310003 17 3 10 0310004 E ISO 14630 Non active surgical implants General requirements ISO 14602 Non active surgical implants Implants for Osteosynthesis Particular requirements FDA Guidance for Intramedullary Rods 510 k FDA Guidance for Intramedullary Rods 510 k Mechanical Loading 20 10 8 1008001 i RE ISO 11135 Medical devices Validation and rout control of ethylene oxide sterilization ISO 11137 Sterilization of health care products Radiation ISO 14160 Sterilization of singl
39. 1 2 0 3 1 41 1 2 3 Um E E 17 2 16 0216001 I VD
40. 33187000 605 JMDN 38152000 606 JMDN 38153000 S87 JMDN 16101003 589 MDN 32847003 603 MDN F 36198003 2 1
41. 3 Q amp A Ql IRENI Al 1 4 4 3
42. 1 NN 3 8
43. 93 1 SO 10993 1 1 4 3 2 3 1 4 3 1 ARU 4 3 2 4 3 3 2 32 4 3 3 2 4 l
44. TM F 1264 FDA 10 Q4 A4 E
45. ation for Unalloyed Titanium for Surgical Implant Applications UNS R50250 UNS R50400 UNS R50550 UNS R50700 ISO 5832 3 Implants for surgery Metallic materials Part 3 Wrought titanium 6 aluminium 4 vanadium alloy ISO 5832 11 Implants for surgery Metallic materials Part 11 Wrought titanium 6 aluminium 7 niobium alloy ASTM F136 Standard Specification for Wrought Titanium 6 Aluminum 4 Vanadium ELI Extra Low Interstitial Alloy for Surgical Implant Applications UNS R56401 ASTM F1295 Specification for Wrought Titanium 6 Aluminum 7 Niobium Alloy for Surgical Implant Applications ASTM F1472 Standard Specification for Wrought Titanium 6Aluminum 4Vanadium Alloy for Surgical Implant Applications UNS R56400 Implants UNS S31675 JIS G4303 JIS G4305 ISO 5832 1 Implants for surgery Metallic materials Part 1 Wrought stainless steel ISO 5832 9 Implants for surgery Metallic materials Part 9 Wrought high nitrogen stainless steel ASTM F138 Standard Specification for Wrought 18 Chromium 14 Nickel 2 5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants UNS S31673 ASTM F1314 Standard Specification for Wrought Nitrogen Strengthened 22 Chromium 13 Nickel 5 Manganese 2 5 Molybdenum Stainless S
46. e use medical devices incorporating materials of animal origin Validation and routine control of sterilization by liquid chemical sterilants ISO 11607 Packaging for terminally sterilized medical devices AAMVFDS 1 TIR 27 Sterilization of health care products Radiation sterilization Substantiation of 25 kGy as a sterilization dose Method VD max AAMI TIR 33 Sterilization of health care products Radiation Substantiation of a selected sterilization dose Method VD max 9 3 31 60 ROR T HEOTI iA AE PE E A DEN ER EO 19 6 12 0612008 1S0 13485 Medical devices Quality management systems Requirements for regulatory purposes 16 169 JIS T 14971 1 ASTM F67 Standard Specific
47. ication for Unalloyed Titanium for Surgical Implant Applications UNS R50250 UNS R50400 UNS R50550 UNS R50700 1 3 2 ASTM F136 Standard Specification for Wrought Titanium 6 Aluminum 4 Vanadium ELI Extra Low Interstitial Alloy for Surgical Implant Applications UNS R56401 13 3 ASTM F138 Standard Specification for Wrought 18 Chromium 14 Nickel 2 5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants UNS 831673 1 3 4 ASTM F648 Standard Specification for Ultra High Molecular Weight Polyethylene Powder and Fabricated Form for Surgical Implants 1 3 5 ASTM F1295 Standard Specification for Wrought Titanium 6 Aluminum 7 Niobium Alloy for Surgical Implant Applications UNS R56700 13 6 ASTM F1314 Standard Specification for Wrought Nitrogen Strengthened 22 Chromium 13 Nickel 5 Manganese 2 5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants UNS 820910 1 3 7 ASTM F1472 Standard Specification for Wrought Titanium 6Aluminum 4Vanadium Alloy for Surgical Implant Applications UNS R56400 1 3 8 ASTM F1586 Standard Specification for Wrought Nitrogen Strengthened 21 Chromium 10 Nickel 3 Manganese 2 5 Molybdenum Stainless Steel Alloy Bar for Surgical Implants UNS S31675 1 3 9 ISO 5832 1 Implants for surgery Metallic materials Part 1 Wrought stainless steel 1 3 10 ISO 5832 3 Implants for surgery Metallic materials Part 3 Wrought titanium 6 aluminium 4 vanadium alloy 1 3 11 ISO 5832 9 Im
48. ought 18 Chromium 14 Nickel 2 5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants UNS 31673 ASTM F1586 Standard Specification for Wrought Nitrogen Strengthened 21 Chromium 10 Nickel 3 Manganese 2 5 Molybdenum Stainless Steel Alloy Bar for Surgical Implants UNS 831675 E889 Y oS ISO 5834 2 Implants for surgery Ultra high molecular weight polyethylene i Part2 Moulded forms ASTM F648 Standard Specification for Ultra High Molecular Weight Polyethylene Powder and Fabricated Form for Surgical Implants 2 Geb 1
49. plants for surgery Metallic materials Part 9 Wrought high nitrogen stainless steel 1 3 12 ISO 5832 11 Implants for surgery Metallic materials Part 11 Wrought titanium 6 aluminium 7 niobium alloy 1 3 13 ISO 5834 2 Implants for surgery Ultra high molecular weight polyethylene Part2 Moulded forms 13 14 JIS G4303 AT wt 1 15 JIS 64305 1 4 RA 1 4 1 17 3 30 0330001 EN GMP QMS 4 4 142 10 3 31 353 1 4 3 ISO 10993 7 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals 2 4 2 2 RAE ENER
50. teel Alloy Bar and Wire for Surgical Implants UNS S20910 ASTM F1586 Standard Specification for Wrought Nitrogen Strengthened 21 Chromium 10 Nickel 3 Manganese 2 5 Molybdenum Stainless Steel Alloy Bar for Surgical ASTM F648 Standard Specification for Ultra High Molecular Weight Polyethylene Powder and Fabricated Form for Surgical Implants ISO 5832 3 Implants for surgery Metallic materials Part 3 Wrought titanium 6 aluminium 4 vanadium alloy ISO 5832 11 Implants for surgery Metallic materials Part 11 Wrought titanium 6 aluminium 7 niobium alloy ASTM F136 Standard Specification for Wrought Titanium 6 Aluminum 4 Vanadium ELI Extra Low Interstitial Alloy for Surgical Implant Applications UNS R56401 ASTM F1295 Specification for Wrought Titanium 6 Aluminum 7 Niobium Alloy for Surgical Implant Applications ASTM F1472 Standard Specification for Wrought Titanium 6Aluminum 4Vanadium Alloy for Surgical Implant Applications UNS R56400 JIS G4303 AT v vA JIS G4305 ISO 5832 1 Implants for surgery Metallic materials Part 1 Wrought stainless steel ISO 5832 9 Implants for surgery Metallic materials Part 9 Wrought high nitrogen stainless steel ASTM F138 Standard Specification for Wr
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