2.04MB
Contents
1.2. Im 4 16
3. 4
4. 16 169 16 169 JIST 14971 l CERES 5
5. IL I Sey 16 169
6. 6
7. JIST 14971 3 4
8. n Z e0 amp 1 Fes 2 RU
9. 4 1 1 1 1 CA 4 2 4 3 15 2 13 0213001
10. Q5 A5 Q6 A6
11. 12 t2
12. 14 amal BXB Phi mis
13. JIS T 14971 JIS T 14971 8
14. EP A 3 4 5
15. 6 7 H H y 1 bet 8
16. ed Ae ncm w 15 imus 0
17. 4 5 Q2 20 10 8 1008001 AF 1008001 A2 1008001 1 4 3 Q3 4 3 3
18. uui jz 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 2 1 2 1 1 2 13 0213001 1 2 2 JIS T0993 1 1 1 2 3 ISO 10993
19. 16 169 JIST 14971 TT T 6 HS T 14971 4
20. Se ni potis 1 JIST 14971 OR 6 9
21. 1 2 2 5 7 16 298 1 1 2 3
22. A3 ASTM F 1264 FDA ASTM F 1264 FDA 10 Q4 A4
23. 4 UBER ASTM F 1264 4 ASTMF 1264 B ASTM F 1264 4 3 17 4 3 3
24. 4 3 2 JIS T 14971 548 3 TS T 14971
25. bii GMP QMS RO 0330001 S 17 3 30 4 7
26. 7 13 2 V
27. 16 169 6 10 6
28. JIS T 0993 1 ISO 10993 1 1 2 3 1 4 3 1 4 3 2 4 3 3 2 3 2 4 3 3 4 3 1 4 3 2 4 3 3 4 3 4 2 4 teu SR E
29. GMP QMS 0330001 17 3 30 4 3 8 16 251698 9 GRAE
30. JIST14971 Z JIS T 14971 JIS T 14971 JIST14971 E K JIS T 1497
31. 17 3 10 0310001 17 3 10 0310003 17 3 10 0310004 ya EA Fa A N 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 EH H ISO 11135 Medical devices Validation a
32. 3 3 a x a 3 4 5
33. 2 3 ENS NINNNS 0310003
34. 2 2 BEARER B PS S EB i 3 MERO t e ERE A D BEI Li Jis CDL FEEST A 23 2 3 1 2 3 2 8F381 HA 7 U a Xj 2 4 2 4 1 2 4 2 243 Ii
35. 6 Mz A JIS T 14971 0216002 5 17 2 16 2 1 3 Q amp A Q1 Al 1 4
36. 16 169
37. 1 ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications UNS R50250 UNS R50400 UNS R50550 UNS R50700 ISO 58323 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 JISG4305 ISO 5832 1 Implants for surgery Metallic materials Part 1 Wrought stainless steel SO 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
38. WE uc E rein EN 5 11 2
39. Us 4 5 6
40. 17 3 10 v 16 BUUJ 3059 2
41. 5 1 SAL 10 52 10993 7 10 3 31 353 53 53 1 5 3 2 IKAI 6 6 1 6 2 17 3 31 0331008 20 3 28 0328003 5
42. mos PING 7 FERUT JIS T 14971 4 2
43. 591 JMDN 33187000 605 JMDN 38152000 606 JMDN 38153000 587 JMDN 16101003 55589 MDN 32847003 603 JMDN 36198003 1
44. 169 JIS T 14971 2
45. 1 2 0 3 1 21 1 2 3 E IL Af DERE RR 1 e i EE HER 17 2 16 0216001 I VD
46. 2 4 Q7 1 AT
47. 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 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 Part2 Moulded forms ASTM F648 Standard Specification for Ultra High Molecular Weight Polyethylene Powder and Fabricated Form for Surgical Implants ISO 58342 Implants for surgery Ultra high molecular weight polyethylene n EER 2 ES RT Es 1 imum 1
48. 1 CE 2 3 10
49. 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 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 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 58
50. 323 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 titanium 6 aluminium 7 niobium alloy 1 3 13 ISO 5834 2 Implants for surgery Ultra high molecular weight polyethylene Part2 Moulded forms 1 53 14 JIS 64305 1 8 45 JIS G4305 1 4 1 4 1 17 3 30 0330001 GMP QMS 4 TR 4 142 10 3 31 353 1 4 3 ISO 10993 7 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals 2 1
51. l 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 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
52. nd 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 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 9 3 31 60 l 3Ep 19466 H 12 A HI SE REESE 9806120055 EIRE OKARA OO RARER XE CO TR C 19 6 12 0612008 ISO 13485 Medical devices Quality management systems Requirements for regulatory purposes 16 169 JIS T 14971
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