ISO 10993-1 is the standard that outlines the framework for the biological evaluation of medical devices. It establishes the regulatory requirements for assessing potential risks arising from a device’s materials, intended use, and patient contact. The November 2025 revision (ISO 10993-1:2025) introduces several updates to key biocompatibility concepts while maintaining the standard’s fundamental role in supporting biological evaluation within a risk management framework.
Duration:
2 hours
Dates and locations:
Available On Demand Until July 15, 2028