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on applying the new ISO 1009 three standards a risk-based approach to biocompatibility my name is Thor Rollins I'm the director of toxicology and Ino consulting here at Nelson laboratories I have been working in at Nelson laboratories for 17 years that whole time I've been working in biocompatibility and I also am an active member on the TC 194 Technical Committee group that is in charge for writing these ISO 10:09 three standards so today we're gonna go through the brand new 10:09 3-1 that came out in August of last year and the changes that they includes for biocompatibility I'm also going to look at how that kind of correlates with the new guidance that were relatively new guidance that the FDA came out with in 2016 and see how we can use both of these documents to evaluate biocompatibility so these are the two documents that I mentioned earlier the first one that 10 online 3 suite is the Bible biocompatibility most people when they think of biocompat

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