The Final Draft International Standard (FDIS) of ISO 10993-1 has been released launching the 8-week ballot period and signaling important changes ahead for medical device manufacturers.
This updated version of the standard brings significant revisions that reshape how biological safety is evaluated. The document places stronger emphasis on risk-based thinking, scientific justification, and the integration of biological evaluation within the broader risk management framework. Rather than relying on predefined testing paths, manufacturers are now expected to tailor evaluations based on device-specific contexts, material characteristics, and clinical considerations…
