??:Pre-clinical Testing Guidance for Endosseous implant

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• ?????????????
• ????????
• ???
• 98.02.17

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• ?????????????
• ??Pre-clinical Testing Guidance for Endosseous
  implant

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• ??????????(Root-form)????????(Endosseous
  implant),?4????????(basket)????(screw)?????(solid
  cylinder)?????(hollow cylinder)????????????????(B
  lade-form)?????????

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• F.3640????(Endosseous implant)
• ???????????????,??????????????????????????,??????
  ?????????????

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• ??????????,???????????(internal or external
  hexagonal )?????(Flat axial surface)???(Thread)???
  ?(Fins)????(Vertical slot)????
• ????????????(??????????)?
• ??????????

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???????(?)

• ???????????
• ????????????(coating)???(Etch)???(Modification)??
  ,?????????????????

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???????????

• ???????(Biocompatibility test)
• ????(Sterility)
• ?????(Performance test)

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• ??/????
• ????????????????????,?????????????????????
• ????????????????????????????????????10???,????????
  ???????????????????????

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??????
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???????(?)

• ???????????????
• ??????(Cytotoxicity)
• ????(Sensitization)
• ?????????(Irritaion / Intracutaneous reactivity)
• ??????(Acute systemic toxicity)
• ???????????(Subacute and subchronic toxicity)

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???????(?)

• ???????????????
• ??????(Genotoxicity)
• ????(Implantation)
• ??????(Chronic toxicity)
• ?????(Carcinogenicity)

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• ??????????,???????(Sterilization
  validation)??SAL(Sterility assurance level)??10-6
• ?????????,????????????????????????????

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• ????(Mechanical test)
• ????
• (Fatigue test)
• ????
• (Compressive forces)

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?????(?)

• ?????????(Compatibility)
• ????(Corrosion test)
• ???????,???????(static strength)???????(Shear
  bonding strength)

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• Guidance for Industry and FDA Staff Class II
  Special Controls Guidance Document Root-form
  Endosseous Dental Implants and Endosseous Dental
  Implant Abutments (2004)
• ISO 7405 Dentistry- Preclinical evaluation of
  biocompatibility of medical devices used in
  dentistry- Test methods for dental
  materials(1997)
• ISO 10993-1 Biological evaluation of medical
  devices -- Part 1 Evaluation and testing within
  a risk management system(2003)
• ISO 14801 Dentistry- Fatigue test for endosseous
  dental implants(2003)