Biocompatibility Hub
  • 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

Bicompatibility Sample Preparation

The resource for the different methods over time
Sample preparation is the cornerstone of any biocompatibility assessment.  If the sample is not prepared correctly the rest of the study conduct is effectively mis-dosed.  In the pharmaceutical world this is a terrible error in study conduct and equally in the medical device arena it needs to be understood.  Many people will ask what has changed in ISO 10993-10 since 2002 and focus solely on that.  This is a terrible lack of understanding.  It is irrelevant how many animals were used if they were not dosed with a proper extract.  Any evaluation of enduring compliance should first and foremost evaluate the method of the extraction process.  As time has marched on the expectations for proper extraction conduct as tightened immensely.   ISO 10993-10 has updated once since 2002 where as ISO 10993-12 has updated twice.  Extract ratios used previously have been removed.  The expectation for surface area calculations over weight to volume ratios has become almost non-negotiable.
ISO 10993-12 1996
ISO 10993-12 2007
ISO 10993-12 2002 
ISO 10993-12 2012
Powered by Create your own unique website with customizable templates.
  • 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