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What is the nature of the patient contact

Will it be on the body, in the body or a route to get things, tissues or fluids into or out of the body?
​This is where we define the tissue contact.  The three categories for biocompatibility are surface contact, externally communicating, or implant.  Surface contacting and implants are pretty typically self explanatory.  But, externally communicating can sometimes confuse some people.  Externally communicating, is something that will serve as route or method to move gases, liquids or solids into or out of the body.  In terms of biocompatibility evaluations, in the body means whatever won't get wet when you jump in a pool.  The concept that the GI tract or lungs are the outside of the body, will trip up many.  Think of it this way, if you inhaled or ingested something, it can have an effect on you.
It will be on the body
It will be a route into or out of the body
It will be in the body
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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