適用範囲 本審査ガイ ドライ ンの適用範囲は
Contents
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4. 2 Q amp A 3 Q amp A 1 8l 1 1 1 1 1 12 12 1 1
5. 16 169 HST 14971 5
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9. JIST 14971 JIST 14971 D 8 5
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12. 6 GMP QMS 0330001 17 3 30 B 4 8 E
13. 16 169 IS T 14971 i 6 S T 14971 4
14. w AP 0310003 E 17 3 10 B G pcs
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22. 243 4 1
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25. 1 SEMEROUME JST 14971 4 2 ftv 4 3 Bib Ze ert 2 HS T 14971
26. ASTM F1264 Standard Specification and Test Methods for Intramedullary Fixation Devices 15 2 13 0213001 1 2 2 JIS T0993 1 1 1 2 3 1 3 1 3 1 ISO 10993 1 18 Biological evaluation of medical devices part1 18 ASTM F67 Standard Specification 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 ASTM F138 Standard Specification for Wrought 18 Chromium 14 Nickel 2 5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants UNS S31673 1 3 5 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 1 3 6 ASTM F1314 Standard Specification for Wrought Nitrogen Strengthened 22 Chro
27. w vx z 5 RS 4 5
28. 6 6 1 17 3 81 0331008 20 3 28 0828008 6 2 _ 17 3 10 0310001 17 3 10 0310003 17 3 10 0310004 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
29. 5 EUR 10 vv 2
30. 6 JIST 4971 16 0216002 17 2 16 2 1 2 3 Q amp A Qi
31. GMPQMS 0330001 17 3 30 4 DR 16 169 16 169 6 10
32. E ERR A te JIST 14971 3 16 169 4
33. 4 RE 4 142 10 3 31 353 1 4 3 ISO 10993 7 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals 24 22 2 3 234 232 BASHAR Y a 2 4 241 242
34. 4 3 4 4 3 1 4 3 3 3 5 1 5 2 5 3 5 3 1 SAL 10 ISO 10993 7 10 3 31 353 532 IKA
35. FDA 1053 4 zv Q4 AA Q5 i
36. Q2 20 10 8 1008001 1008001 A2 1008001 1 43 Q3 4 3 3 A3 ASTM F 1264 FDA ASTM F 1264
37. 1 1 1 42 43 15 2 13 0213001 JIS T 0993 1 ISO 10993 1 1 2 3 1 4 3 1 4 3 2 43 32 232 4 33
38. 2 w EARRA A
39. ri 16 169 JIS T 14971 2 ZO
40. E JIST14971 Bit SU 2 3
41. 3 N 4 5 11
42. 678 9 JIST14971 JST14971 JIST 14971 i JST14971
43. L JIS G4303 A7vvwABpe 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 Steel 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 Implants S 531675 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 Ap
44. ISO 13485 Medical devices Quality management systems Requirements for regulatory purposes 16 169 JIS T 14971 ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications UNS R50250 UNS R50400 UNS R50550 UNS R50700 ISO 583233 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 6A luminum 4Vanadium Alloy for Surgical Implant Applications UNS R56400
45. 24 3 1 4 ASTM F 1264 4 TORT REER TRER 432 ASTMF 1264 4 3 3 ASTM F 1264
46. FDA Guidance for intramedullary Rods 510 k Mechanical Loading 20 10 A 8 1008001 ISO 11135 Medical devices Validation and rout control of ethylene oxide sterilization ISO 11137 Sterilization of health care products Radiation 5 ISO 14160 Sterilization of single 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 AAMI FDS 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 SEpk94E3 H 31 AHIR EOE ERARO KKR DUBIE OE O4R IC BH D 3 ZENTI 19 6 12 0612005 19 6 12 0612008
47. 3 4 EIUS 2 5 7 16 EREHE ERE 298 1 1 2 5915 605 606 587 589 603 GMDN 33187000 JMDN 38152000 MDN 38153000 JMDN 16101003 JMDN 32847003 JMDN 36198003 1
48. mium 13 Nickel 5 Manganese 2 5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants UNS S20910 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 S3 1675 1 3 9 ISO 5832 1 Implants for surgery Metallic materials Part 1 Wrought stainless steel 13 1 1 3 1 1 3 1 1 3 1 1 3 1 1 3 1 1 4 1 4 1 0 ISO 5832 3 Implants for surgery Metallic materials Part 3 Wrought titanium 6 aluminium 4 vanadium alloy 1 ISO 5832 9 Implants for surgery Metallic materials Part 9 Wrought high nitrogen stainless steel 2 ISO 5832 11 Implants for surgery Metallic materials Part 11 Wrought titanium 6 aluminium 7 niobium alloy 3 ISO 5834 2 Implants for surgery Ultra high molecular weight polyethylene Part2 Moulded forms 4 JIS G4300 AT vw VASE t 5 JIS G4305 BIEIEEREZA 7 Y V A SRARCRCOR AE 17 3 30 0330001 U 5 GMP QMS
49. plications 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 A7 v v ARES 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 831673 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 ISO 58342 Implants for surgery Ultra high molecular weight polyethylene Part2 Moulded forms ASTM F648 Standard Specification for Ultra High Molecular Weight Polyethylene Powder and Fabricated Form for Surgical Implants 2 FLA V
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