適用範囲 本審査ガイ ドライ ンの適用範囲は
Contents
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11. 2 3 PSEPREEROE LC V B ERR 4
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14. 4 3 1 4 ASTM F 1264 4 4 3 2 ASTM F 1264 4 3 3 ASTMF 1264 4 3 4 4 3 1 4 3 3 gt CA
15. 4 4 5 Q2 20 10 8 1008001 gb UNE aui eii audis EBVSRHOBE OV GLF hoo BEM A2 1008001 1 4 3
16. GMP QMS GEREEBRXESS 0330001 S 3ERE 1756 3 H 30 4 E N RA ZHE ER b ER
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19. 6 169 JIST 14971 xul C JIS T 14971 4 Fe 7 JIS T 14971
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21. 16 551695 GREE 16 169 T amp P3 BRE FE PS ST BE PRSE 27 6 6 d pibe n
22. 16 169 JIS T 14971 r l 2 I
23. 16 169 16 169
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29. 10 3 GMP QMS 0330001 17 3 30 4 3
30. 5JR JIS T 14971 Az JIS T 14971 6 JIST 14971
31. 16 169 HST 14971 16 169 icd B Wurm 6
32. JIST14971 ST14971 JsT14971 X K JST14971 tb
33. 1 l i ASTM F67 Standard Specification 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 JIS G4303 AT wVwASE 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 Stee Bar and Wire for Surgical Implants UNS S31673 ASTM
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35. l 15 9 2 j _ l 3
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37. JIS T 14971 6 9 JSTI4971
38. 0328003 62 17 3 10 0310001 17 3 10 0310003 UER 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 FDA Guidance for Intramedullary Rods 510 k Mechanical Loading 204F 10 H 8 1008001 QST ISO 11135 Medical devices Validation and rout control of ethylene oxide sterilization IS
39. 1 42 15 2 13 0213001 E LIC CI T dic nS TOONIEE ISO JO 1 4 3 2 3 1 4 3 1 ARU 4 3 2 4 3 3 2 3 2 4 3 3 2 4
40. Q3 43 3 A3 ASTMF 1264 FDA l 275 ASTM F 1264 FDA 10 Q4 A4
41. 353 1 4 3 ISO 10993 7 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals 2 22 2 3 2 3 1 2 3 2 2 4 2 4 1 2 4 2 243
42. 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 Wiouglt Nitrogen Strengthened 21 Chromium 10 Nickel 3 Manganese 2 5 Molybdenum Stainless Steel Alloy Bar for Surgical Implants UNS 831675 l 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 SO 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 vv AREE JIS G4305 ISO 5832 1 Implants for surgery Metallic materials Part 1 Wrought s
43. 3 4 BIRR TEPSBIEHREPUSTSESEUAM 2 5 7 16 298 1 1 2 391 JMDN 33187000 605 JMDN 38152000 606 UEPSIEIXEJH EJECRSPSST JMDN 38153000 587 JMDN 16101003 S89 MDN 32847003 603 JMDN 36198003 1
44. O 11137 Sterilization of health care products Radiation 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 AAMIFDS 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 19 6 12 0612005 19 6 12 0612008 ISO 13485 Medical devices Quality management systems Requirements for regulatory purposes 16 169 JIS T 14971
45. S T 14971 o LI
46. STM FI264 Standard Specification and Test Methods for Intramedullary Fixation Devices 1 20 1 2 1 15 2 13 0213001 1 2 2 JIS T0993 1 1 1 2 3 ISO 10993 1 18 Biological evaluation of medical devices part1 18 13 1 3 1 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 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 PuresaeneMoleeniar Weis 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 Chromium 13 Nickel 5 Manganese 2 5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants UNS 820910 1 3 7 ASTM F1472 Stan
47. dard 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 3832 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 1 ISO 5832 9 Implants 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 l 1 3 13 ISO 5834 2 Implants for surgery Ultra high molecular weight polyethylene Part2 Moulded forms 1 3 14 JIS G4303 RAFY v AAE 1 3 15 JIS G4305 1 4 RA 1 4 1 17 3 30 0330001 GMP QMS 4 EE 4 _ 1 4 2 10 3 31
48. tainless steel ISO 5832 9 Implants for surgery Metallic materials Part 9 Wrought high nitrogen stainless steel ASTM F138 Standard Specification for Wrought 18 Chimie 14 Nickel 2 5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants UNS S31673 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 SO 5834 2 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 GRHHBXERIBEANSISERCUA R74 V poen uz purge E 1
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