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体内固定用髄内釘審査ガイドラインについて
Contents
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11. 16 169 JIST 14971 6 JIST 14971 HAREA RANSIE ZU 4
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20. 2 Q amp A 3 Q amp A 1 1 1 1 1 1 1 ASTM F1264 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 1 3 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 Titaniu
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24. 19 6 12 0612008 ISO 13485 Medical devices Quality management systems Requirements for regulatory purposes 16 169 JIS T 14971 1 l 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 Aluminu
25. Q2 20 10 8 1008001 1008001 A2 1008001 1 4 3 Q3 4 3 3 A3 ASTM F 1264 FDA ASTM F 1264
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29. 1 2 l 3 4 l HY 2 5 7 16 298 1 1 2 591 PEPSISIGERUKBREH BAS JMDN 33187000 605
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31. 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 GERI ISO 11135 Medical devices Validation and rout control of ethylene oxide sterilization ISO 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 AAMUFDS 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 3EBR94E3 8 31 AIREKO ERARO HRRE ORERE EDRI ATD E G iovcJ 19 6 12 0612005
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34. 4 1 1 1 RR RE OR 42 l 13 2 13 0213001 JIS T 0993 1 ISO 10993 1 1 4 3 2 3 1
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39. 9 JIS T 14971 JIS T 14971 Z Io JIS T 14971 JST14971
40. 53 53 532 6 6 1 17 3 31 0831008 20 3 28 0328003 6 2 17 3 10 0310001 17 3 10 0310003 17 3 10 0310004 5
41. JMDN 38152000 606 MDN 38153000 S87 JMDN 16101003 98 589 JMDN 32847003 603 MDN 36198003 1
42. etd SR n l i at 7 MS T 14971 Z 4 2 Z 4 3
43. r 169 JIS T 14971 JIS T 14971 16 169 16 169 JIST 14971 eet S rd LET F 5
44. 4 3 1 ARU 4 3 2 4 3 3 2 3 2 4 3 3 2 4 4 3 1 4 ASTM F 1264 4 4 3 2
45. 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 vw AS 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 Chroni 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 ISO 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
46. JIS T 14971
47. Sy 1 2 0 3 1 21 1 2 3 Um E 17 2 16 0216001 1 VD
48. anium 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 1 3 15 JIS G4305 1 4 WRA 1 4 1 17 3 30 0330001 UJ A GMP QMS 4 4 _ 142 10 3 31 353 l 1 4 3 ISO 10993 7 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals 2 1 2 2 BAA ERER 2 3 23 1
49. m 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 JISG4305 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 UNS S31675 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 DNE
50. m 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 S31673 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 1 3 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 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 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 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 tit
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