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The New and Improved ISO 10993-12:2021—What Is Really Changing

Published In: MDDI Online

Every time there is an update to a standard, especially an overarching one like the ISO 10993-12 standard that covers sample preparation recommendations, it comes with a slight dose of anxiety. This is because it might mean there is now a gap between what is expected from the regulation and what was done when the testing or assessment for a medical device was originally performed. This time, however, I must say that the updated document was only slightly modified, without unexpected twists and turns, so everyone can breathe a little easier.


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