Cytotoxicity, Sensitization and Irritation, sometimes known as CSI, are three of the most common tests performed on medical devices. In this episode of BiocompCHATibility, our hosts talk about these tests, including common pitfalls and regulatory expectations.
“Aside from part 1 of 10993, giving us the overall general guidance, we’re talking for cyto of ISO 10993, Part 5 and then part 10. As it stands today, both sensitization and irritation get covered in part 10. So again, even inside those standards, whether it be part 5 or part 10, for all these endpoints, there are quite a few different methods for how one goes about evaluating them, or testing for them. Once you get down to the point that you need a test. It’s a lot of testing that can be considered in terms of different methodologies. But which one you need?” -Don Pohl
Key Discussion Points include:
- Which test method is the “right” test method?
- What does the composition of my device have to do with a cytotoxicity test?
- Sensitization—why does it take so long?
- Is there a correlation between irritation and cytotoxicity?
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Product Marketing Manager – Biological Safety, NAMSA
Sheri joined NAMSA in 2003 and currently serves as Global Product Marketing Manager of Biological Safety. She has supported customers in a variety of commercial operations and management roles, and was an integral leader in the development of NAMSA’s biological safety consulting business. Additionally, Sheri created the much sought-after NAMSA Training Series for the biological evaluation of medical devices. Prior to NAMSA, Sheri was the marketing lead for a mechanical fatigue laboratory and consulting business where she worked primarily with cardiovascular implant manufacturers. Sheri holds a Bachelor’s Degree from the University of Nebraska.
Principal Product Development Strategist, NAMSA
Don holds a Bachelor’s degree from Ohio State University. He has over 25 years of experience in the pre-clinical 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.