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How long will the patient Contact Be

Will the device be in contact with the patient cumulatively less than 24 hours, less than 30 days or greater than 30 days?
The next step in the process is to accurately describe the patient contact time.  Less than 24 hours is considered limited contact.  Greater than 24 hours but less than 30 days is considered to be prolonged contact.  Greater than 30 days is considered permanent.  Bear in mind, that the exposure your considering should be viewed as cumulative.  If the device is changed daily for a period that could be longer than 30 days, this is a permanent exposure.
Less than 24 hours
Greater than 24 hours but less than 30 days
30 days or greater
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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