Navigating the 2025 ISO 10993‑1 Revision - Seguridad Mania.com - España y América Latina

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 introduces several updates to key biocompatibility concepts while maintaining the standard’s fundamental role in supporting biological evaluation within a risk‑management framework. This presentation will outline the most significant changes to ISO 10993-1 and examine how they affect the design of biological assessment strategies. Key topics include the enhanced alignment with ISO 14971 regarding risk management principles, the updated considerations for biological effects, and the strengthened emphasis on lifecycle based evaluation. Second talk: Challenges Encountered During ISO 10993-18 Testing & Possible Ways Out E&L testing according to ISO 10993-18 followed by a toxicological risk assessment (TRA) according to ISO 10993-17 can replace biological testing to assess systemic endpoints, e.g. carcinogenicity, genotoxicity, hereby reducing costs and saving time and animals. This presentation will give you an introduction on how E&L testing is performed at Nelson Labs and possible ways out for challenges that can be encountered. The presentation will start with a brief introduction on E&L testing for medical devices, as described in ISO 10993-18. Throughout the subsequent step-by-step explanation of how a study is performed at Nelson Labs, possible challenges and solutions are discussed. Challenges encountered in sample requirements, extraction conditions, exhaustivity determination, sample preparation and more will be discussed.