Medical Devices and Toxicological Risk

Published in September 2023, the new ISO 10993-17 introduces a broader approach to the toxicological risk assessment of medical devices.
It goes beyond release limits to provide an integrated evaluation that considers the presence, nature, and behavior of chemical constituents under real use conditions.

🔍 Key updates include:
✅ A stepwise approach within the Biological Evaluation Plan (BEP)
✅ Introduction of the Threshold of Toxicological Concern (TTC) concept
✅ Focus on substance-based devices and complex mixtures
✅ Alignment with ISO 14971:2019 and ISO/TS 21726:2019 standards

💡 A step forward toward more conscious design and enhanced patient safety.
The ISEMED team supports manufacturers in the effective and methodical application of the new standard.

📄 Read the full article:https://www.isemed.eu/en/t-magazine/