It is relevant for all medical devices that come into direct or indirect contact with the body, regardless of the type and duration of contact. The essential change compared to the first edition ISO 10993-17:2002 includes an expansion of the scope, which is directly evident from the change in the title. While ISO 10993-17:2002 was only applicable to the "demonstration of permissible limits for leachable components", the scope of the new version has been expanded to all components of medical devices. This now includes all substances present in or on the final medical device. Also, the term "Allowable limits" has been completely removed from the standard, which further emphasizes the shift in focus. Finally, ISO 10993-17:2023 clarifies when a toxicological risk assessment is recommended and contains detailed information about its requirements. Although the revised version of ISO 10993-17 now contains more general information and also more detailed instructions, it is still intended for use by toxicologists or other experts who have demonstrable qualifications.
