Key Updates to ISO 10993-17: 2023 Revisions for Biological Evaluation of Medical Devices

The revised ISO 10993-17 standard marks its first significant update in nearly 20 years, introducing critical changes that impact the biological evaluation of medical devices. This resource highlights these updates, including new terminologies, risk management processes, and concepts like the Toxicological Screening Limit (TSL). Manufacturers who understand and implement these changes will be better equipped to meet compliance standards, streamline product approval processes and maintain market access.

What to expect:

• An overview of key terminology updates and their implications for device evaluation.
• Detailed explanation of the new Toxicological Screening Limit (TSL) concept and how to apply it.
• Insights into maximum exposure calculations (EEDmax) and the role of toxicological databases.
• Recommendations for addressing data gaps in chemical substance assessments.