ISO 10993-1 is a foundational standard for the biological evaluation of medical devices, guiding how manufacturers assess safety and meet global regulatory requirements. With the new version published in November 2025, we’re looking at one of the most significant updates to biocompatibility standards in recent years. Anticipating the publication after the Final Draft International Standard (FDIS) was approved, three of our biocompatibility experts held a live panel discussion about the key changes to ISO 10993-1. These experts covered the following updates to the standard:
• Enhanced risk-based approach
• Clarified guidance and expansion on device classification
• Increased genotoxicity application
• Improved integration with ISO 14971
• Updated guidance on biocompatibility at end of life and for reusable devices
• Updated or expanded guidance annexes and test methods
The webinar also includes a Q&A session.
Take advantage of this opportunity to gain practical insights from our biocompatibility experts into how these changes may impact your product development and regulatory submissions.
Learn more about the presenters below.
