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The biocompatibility categories that need to be addressed

Below are the biological effect categories that need to be addressed for a product such as yours which is considered a prolonged tissue/bone/dentin externally communicating device
​This links presented will bring you to pages specific to that biological category of biocompatibility evaluations that are required to be addressed.  This does not mean that tests for each category necessarily need to be conducted.  But it does mean that they need to be addressed
  • Cytotoxicity
  • Sensitization
  • Irritation
  • Acute Systemic Toxicity
  • Pyrogenicity
  • Sub-Acute Toxicity
  • Sub-Chronic Toxicity
  • Genotoxicity
  • Implantation
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  • Home
  • Suppliers
    • Contract Laboratories >
      • Toxikon
      • Nelson Labs
      • Eurofins
    • Material Suppliers
    • Contract Manufacturers
    • Consultants >
      • Intrinsic Medical Group
  • Library
    • Which Endpoints Should I Consider?
    • Test Method Summaries
    • White Papers, Articles and Presentations >
      • FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires
      • FDA Recognized Consensus Standards Update
      • The Ten Steps of a Biological Evaluation whtin a Risk Management Process
      • Post-Approval Biocompatibility
      • The Failed Cytotoxicity Test
      • Biocompatibility Deficiency Letters Part 2
      • ISO 18562-1 (2017) Biocompatibility Evaluation of Breathing Gas Pathways
      • In-Vivo Thrombogenicity 101
      • Technical Considerations for Additive Manufactured (3D Printed) Devices
      • How to Pick a Biocompatibility CRO
      • Mitigating Risk in Biocompatibility
      • Biocompatibility Deficiency Letters
      • The First Steps in Biocompatibility
  • Contact
    • About
  • Search