In 2018 TC194, which is the ISO committee for biocompatibility, released a new version of 10993-1. This new version focused on a risk-based approach and made significant changes to the prior version. Now more significant changes to the main biocompatibility standard are being made. In this webinar Helin Räägel (read more about her below) discusses the areas of the standard that are being changed, the reasoning behind the changes, and the initial acceptance of these changes around the globe.