Strategic Implementation of ISO 10993-17: Disposable Medical Devices

The webinar ''Strategic Implementation of ISO 10993-17:Disposable Medical Devices'' aims to give an overview of the new Part 17 of ISO 10993, discussing the main and new key concepts described in it and focusing on its applicability in relation to specific types of devices, such as disposable medical devices.

The revisions proposed in 10993-17 will expand toxicological risk estimation to include prioritisation of chemicals by screening limit, estimation of exposure dose for each component, and use of risk acceptance criteria to assess the margin of safety.

Some of these new concepts will be analysed in order to determine when and how they can be applied to specific cases with the goal of defining increasingly tailored strategies for different medical devices.