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Testing Method summaries

It should be noted that the FDA and other regulatory bodies may only accept a portion of a ratified ISO document.  To ensure your method or testing program adheres to the appropriate agency visit the associated websites.  For FDA go to https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm and select "ISO" for the Standards Organization and "Biocompatibility" for Specialty Task Group Area.
Cytotoxicity
Acute Systemic Toxicity
Genotoxicity
Sensitization
Pyrogenicity
Implantation
Sample Preparation/Extracts
Irritation
Sub-Acute Sub-Chronic Toxicity
Hemocompatibility
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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