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Contents
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3. 1
4. a 4 14 1 b oc g 4 14 1 b cj d e f g h
5. ISO 10451 2010 Dentistry Contents of technical file for dental implant systems ya 2 4 JIS JIS
6. 4 4 a 7 4 4 b 5 4 5 e JIS
7. 4 14 4 14 1 a b 3 c d f g
8. k D m 2 3 4 5 6 JIS K 7171 2008 ISO 178 2010 Plastics Determination of flexural properties MOD JIST 7401 1 1 ISO 5832 2 Implants for surgery Metallic materials Part 2 Unalloyed titanium lg ul MOD JIS T 7401 2
9. 4 7 JIS T 14971 4 8 a b JIS T 0993 7 JIS T 0801 1 ISO TS 11135 2 JIS T0806 1 JIS T 0806 2 JIS T 0806 3 ISO 14937
10. iP 1 4 4 14 2 4 15 m JIS JIS Du ISO 10451 2010 MOD 1 2 JIS TE E oe MOD t 6666 XXXX 1 JIS T XXXX 9999 Dn
11. 4 13 4 13 1 JIS T 0841 1 JIS T 0841 2 4 13 2
12. JIS 3 a ISO 1942 b 4 Se 5 5 1 5 2 S 3 6
13. 3 2 dental implant system 3 3 coating 3 4 technical file 4 4 1 NM 4 2 4 14 ne oO
14. JISK 7171 ES E 4 9 gt E 1 oO h e ISO 10993 9 4 6
15. ISO 17664 JIS T 0816 1 4 9 JIS T0993 1 JIS T 6001 ISO TS 22911 JIS ISO JIS T 7401 1 JIS T 7401 2 ISO 6474 1 ISO 13356 4 10 17 3 23 36 4 11 4 12
16. 4 10 4 10 ISO 14155 1 36 ISO 14155 2 4 14 4 14 JIS JIS 4 15 4 14 1 4 14 h ISO gt BR i ISO h JIS 6666 XXXX L 0 gt DJIS CD mp VJIS VJIS
17. 2 6 4 ISO 5832 3 Implants for surgery Metallic materials Part 3 Wrought titanium 6 aluminium 4 vanadium alloy MOD ISO 1942 Dentstry Vocabulary ISO 6474 1 Implants for surgery Ceramic materials Part 1 Ceramic materials based on high purity alumina ISO 13356 hmplants for surgery Ceramic materials based on yttria stabilized tetragonal zirconia Y TZP JA JIS 0 gt JIST XXXX 9999 ISO 10451 2010 Denti
18. ISO 129 1 Technical drawings Imdication of dimensions and tolerances Part 1 General principles MOD ISO 10993 9 Biological evaluation of medical devices Part 9 Framework for identification and quantification ofpotential degradation products ISO TS 11135 2 Sterilization of health care products Ethylene oxide Part 2 Guidance on the application of ISO 11135 1 ISO 14405 2 Geometrical product specifications GPS Dimensional tolerancing Part 2 Dimensions other than linear sizes ISO 14801 Dentistry Inplants Dynamic fatigue test for endosseous dental implants ISO 14937 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development validation and routine control of a sterilization process for medical devices ISO 17664 Sterilization of medical devices Imformation to be provided by the manufacturer for the processing of resterilizable medical devices ISO TS 22911 Dentistry Preclinical evaluation of dental implant systems Animal test methods 17 3 23 36 3 3 1
19. 9999 Contents of technical file for dental implant systems 1 RY 2 2010 2 ISO 10451 JA 7TT ISO 104
20. SJ J 0 X ee ph 2 2 3 1 3 2 4 5 ISO 14801 a b lt d KK 1
21. 4 2 4 3 a RE b JIS Z 8317 1 ISO 14405 2 c 4 4 a 1 100 1 1 1 1 2 1 3 1 4 1 5 2 2 1 Si 3
22. 4 9 pp 4 10 li hksespn 4 12 oo 4 13 ooo 4 14 12 1 QDMA JSA JIS T XXXX
23. 51 2010 Dentistry Contents of technical file for dental implant systems MOD MOD JSO IEC Guide 21 1 JIST0801 1 1 ISO 11135 1 Sterilization of health care products Ethylene oxide Part 1 Requirements for development validation and routine control of a sterilization process for medical devices IDT JIST0806 1 1 A ISO 11137 1 Sterilization of health care products Radiation Part 1 Requirements for development validation and routine control of a sterilization process for medical de
24. nally sterilized medical devices Part 2 Validation 1 dy requirements for forming sealing and assembly processes IDT JIST 0993 1 1 ISO 10993 1 Biological evaluation of medical devices Part 1 Evaluation and testing within a risk management process IDT JIST0993 7 7 ISO 10993 7 Biological evaluation of medical devices Part 7 Bthylene oxide sterilization residuals IDT JIST6001 f ISO 7405 Dentistry Evaluation of biocompatibility of medical devices used in dentistry MOD JIST14971 ISO 14971 Medical devices Application of risk management to medical devices DT JIS Z 8317 1 1
25. stry Contents of technical file for dental implant systems DJIS D ID TV JIS V JJIS ME 1 2 3 3 1 ISO 1942 3 4 3 3 3 4 H 4 4 4 4 4 a 7 a 7 4 5 a 4 5 JIS
26. vices IDT JIS T0806 2 2 ISO 11137 2 Sterilization of health care products Radiation Part 2 Establishing the sterilization dose IDT JIST0806 3 3 ISO 11137 3 Sterilization of health care products Radiation Part 3 Guidance on dosimetric aspects IDT JIST 0816 1 ISO 17665 1 Sterilization of health care products Moist heat Part 1 Requirements for the development validation and routine control of a sterilization process for medical devices IDT JIST 0841 1 1 ISO 11607 1 Packaging for terminally sterilized medical devices Part 1 Requirements for materials sterile barrier systems and packaging systems IDT JIST 0841 2 2 ISO 11607 2 Packaging for termi
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