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Considerations for Navigating ISO 22442-3 Viral Inactivation Studies



EN ISO 22442 is the standard for medical devices that use tissues from preclinical models and their derivatives. Manufacturers must show that they can effectively inactivate and remove viruses from raw materials and finished products. The types and amounts of non-human materials in medical devices differ, including bovine/porcine heart valves and hemostatic sponges, among others. Join our NAMSA experts as we explore key aspects of your viral inactivation testing program.

Our speakers will explain the use of non-human tissue and derivatives in developing medical devices. They enhance performance, stabilize formulations, and improve properties.


Attendees will gain insights on:

  • When to consider a viral inactivation study
  • Steps in the study process and what to think about before starting
  • Customizing viral inactivation studies and potential challenges
  • Considerations for molecular screening and batch release


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