What does risk-based biocompatibility under the new ISO 10993-1 really look like?

The era of the "checklist" approach to biocompatibility is officially over. With the publication of ISO 10993-1:2018 and the recent 6th edition (ISO 10993-1:2025), regulatory bodies like the FDA and EU Notified Bodies have shifted their focus from animal testing to a sophisticated, data-driven Biological Evaluation Plan (BEP). But what does this shift actually look like in practice? How do you move beyond Table A.1 to build a justification that satisfies regulators while potentially reducing unnecessary testing? In this session of DeviceTalks Tuesday, we simplify performing risk estimation by breaking down the transition from an overall risk-based approach to identifying hazards and harms. We will explore how to integrate ISO 14971 risk management principles to assess not just intended use, but also reasonably foreseeable misuse and lifecycle evaluation. Whether you are dealing with legacy devices or novel materials, this session provides a practical roadmap for leveraging chemical characterization, toxicological risk assessment (TRA), and bioequivalence to streamline your path to market. In this webinar, you will learn about: Decoding the New Standards: Identify the critical changes in the 2025 revision, including new definitions for Contact Days and the reorganization of biological effect tables. Addressing Misuse and Lifecycle Evaluation: Discover how to evaluate biological risks beyond "time zero," including the impact of reprocessing and off-label clinician use. Regulatory Expectations: Gain insights into how the FDA and regulatory bodies around the globe evaluate a Biological Evaluation Report (BER) in 2026.