What’s New in the World of ISO 10993‑1?
With the newly revised and completely restructured ISO 10993‑1, regulatory expectations are becoming significantly stricter. In our video, Marcel Dörkes explains the key changes introduced in the updated ISO 10993‑1.
In our December 2025 interview, our expert Marcel Dörkes outlines the most important updates included in the revision, such as:
- Stronger integration of the risk management process in accordance with ISO 14971
- Inclusion of reasonably foreseeable misuse within the scope
- Revised categorisation of cumulative exposure duration
- … as well as other relevant adjustments that are crucial for both current and future biological evaluations.
These changes affect testing strategies, risk assessments, documentation requirements and regulatory expectations — and should be carefully considered by manufacturers.
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