Medical Devices: How Toxicological Risk Assessment Is Changing
ISEMED Channel: our space dedicated to manufacturers of medical devices, IVDs, cosmetics, and biocides.
Here you'll find updates, innovations, and regulatory insights to stay up to date in a constantly evolving sector.
In this new content, we talk about a regulatory update that marks a real turning point for the sector: ISO 10993-17:2023, which redefines the criteria for toxicological risk assessment of medical devices.
The new standard introduces a systematic approach that goes beyond the analysis of leachables alone, focusing instead on the identifiable constituents of the device. Outdated concepts such as the “permitted limit” are replaced by more robust and scientifically validated parameters such as:
- TI (Tolerable Intake)
- TCL (Toxicological Concern Level)
- EEDmax (Expected Exposure Dose)
- MoS (Margin of Safety)
- and values derived from the state of the art such as NOAEL, LOAEL, and BMD.
Lorenzo Pasotti, Regulatory Affairs Consultant at ISEMED, guides us through these changes, clearly and concretely explaining the implications for manufacturers—especially those of substance-based devices.
Watch the video 👇