CSI: Cracking the Case

BiocompCHATibility

A NAMSA podcast series that addresses specific medical device evaluation scenarios and challenges.

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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?

Also be sure to check out our Biocompatibility Strategy Navigator.