The Final Draft International Standard (FDIS) of ISO 10993-1 introduces the most significant updates in decades to the biological evaluation of medical devices. Among other things, these
revisions reinforce a risk-based framework aligned with ISO 14971, expand expectations for particulate evaluation, and redefine device categorization and contact duration. Together, the updates push manufacturers toward stronger rationales and more rigorous evaluation.
This whitepaper provides context for the revision, highlights three of the most impactful updates, and captures some of the most common questions raised by industry professionals during recent panel discussions. Practical insights are offered to help device manufacturers, toxicologists, engineers, and regulatory teams prepare for adoption in global markets.
