Open only to full-conference registrants with a badge. Collect your ticket at the Solutions Circle check-in desk at least 15 min before session start. First-come, first-served seating; standby tickets issued when full. Seats held for 3 minutes after start time.
Principal Consultant Lucendra SA Mont-sur-Rolle, Vaud, Switzerland
Description: The revision of ISO 10993-17:2023 has reshaped how toxicological risk assessment (TRA) is approached in medical device evaluations. A range of thresholds now guide both chemists, toxicologists and regulators, yet their correct interpretation and application remain a source of discussion: - DBT (dose-based threshold): derived from the threshold of toxicological concern (TTC) or based on Kramer classification and used in AET calculations. - AET (analytical evaluation threshold): the working threshold for chemists in extractables/leachables studies. - TSL (toxicological screening limit): a decision-making threshold for toxicologists. Additional concepts will also be introduced to contextualize their use, including cohort of concern (CoC) and the role of uncertainty factors (UFs) in AET calculation.
This roundtable will explore the practical use of thresholds in chemical characterization (CC) and toxicological risk assessment (TRA), highlighting common pitfalls from both scientific and regulatory perspectives. Drawing on experience with ISO 10993-17:2023, it will showcase effective practices, remaining challenges, and ways to align chemists, toxicologists, and regulators. Designed as an interactive forum, the session will offer strategies to avoid misinterpretation and build a shared understanding of DBT, AET, and TSL to strengthen risk assessments and improve regulatory consistency.
Learning Objectives:
Upon completion, participants will be able to define and differentiate DBT, AET, and TSL in the context of ISO 10993-17:2023, and explain their respective roles in chemical characterization and toxicological risk assessment.
Upon completion, participants will be able to apply strategies to interpret and use thresholds effectively, avoiding common pitfalls and aligning the perspectives of chemists, toxicologists, and regulators to strengthen risk assessments.
