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ISO 10993-23:2021 Tests For Irritation – What Manufacturers Must Understand Today



February 3, 2021

Access On-Demand Webinar Here.

Join NAMSA for this special breaking webinar in which we discuss ISO 10993-23:2001, “Biological evaluation of medical devices — Part 23: Tests for irritation,” released on January 20, 2021.

Highlighted within Part 23 of the new ISO standard is information on irritation assays and their viability for medical device testing, with a focus on possible medical device contact hazards, sometimes producing irritation. Previously, manufacturers could find irritation test recommendations in ISO10993-10 with sensitization recommendations, however, with the issuance of Part 23, sensitization and irritation are now considered to be different standards.

What has Changed?
One of the main components of this change is that manufactures will now see the recommendation that in In Vitro testing be completed prior to In Vivo testing. While In Vitro irritation is one of the latest to reach the normative text of the ISO standards, manufactures and laboratories must be prepared to evaluate and utilize this test method.

This webinar will not only provide an overview of Part 23, but will also discuss major changes, including the normative recommendation for In Vitro irritation. Join us to learn more about the opportunities and challenges for laboratories and manufacturers related to the standard, as well as the following discussion points:

  • What are the main differences between this standard and 10993-10?
  • What methodology does the new In Vitro model follow?
  • How do the three Rs—Replacement, Reduction and Refinement—apply to this new standard?
  • Does the FDA accept In Vitro irritation?
  • What are some challenges of an In Vitro study?
  • How can manufacturers prepare for the new ISO 10993-23?
  • What is the recommendation if an In Vitro test doesn’t pass the requirements?
  • What are potential limitations when utilizing an In Vitro irritation test?

Time will also be allotted for Q&A.

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Don Pohl

Principal Product Development Strategist

Don holds a Bachelor’s degree from Ohio State University and has over 25 years of experience in the preclinical evaluation of medical devices for biological safety. During his career, he has held a variety of positions ranging from laboratory supervision/management, GLP Study Director, Technical Specialist for Laboratory Information Management System, Technical Specialist and project manager for Biological safety and biological risk assessment consultation. He has specific expertise in the evaluation process outlined in ISO 10993-1 as well as the expectations of the USFDA and other countries in their interpretation of the biological safety evaluation of medical devices.