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Answering Your Questions on ISO 10993-18:2020


During this episode, our hosts are joined by Andy Wyen, Toxicologist at NAMSA, to answer questions received during NAMSA’s live Webinar on the new ISO 10993-18:2020. As this new standard is a complete re-write from the 2005 version, it is stirring up industry and leaving many manufacturers confused and searching for the most efficient adoption methods.

Topics include:

  • Triplicate testing and how to determine if there is low variability in a sample before extraction has occurred
  • AET: How to calculate the number of devices used in clinical use for a chronic device that can be used during someone’s lifetime
  • Whether NVR used to establish exhaustive conditions affect the AET calculation for analysis
  • Whether the same replicates (single, duplicate, and triplicate) apply to NVR

With the release of 10993-18:2020 on January 15, 2020, it is crucial for professionals involved with the Biological Evaluation of medical devices to understand the standard’s use, interpretation and requirements, as well as how an effective link now exists to the overall Biocompatibility Evaluation as described in ISO 10993-1.

Connect with Andy: https://www.linkedin.com/in/andy-wyen-3448486/

Also be sure to check out our Biocompatibility Strategy Navigator.