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Requirements and Impact of the New Guideline – ISO 10993-23: Tests for Irritation

March 9, 2021

12:00 pm EST

The requirements for assessing irritation is now moved from ISO 10993-10 to ISO 10993-23 and with this new standard comes the inclusion of in vitro irritation testing. As we move further to reduce animal testing and incorporate the 3 R’s (replace, reduce, refine) into biocompatibility assessment for medical devices, this is a critical turning point. Join us for an intense and informative discussion on this standard and learn what steps to take to incorporate this testing into your biocompatibility program.


  • Review of the in vitro testing method
  • When to pursue in vitro or in vivo testing
  • How to transition from in vivo to in vitro testing
  • Current regulatory acceptance