The new framework to assess the biological safety of medical devices ensures that materials that come into contact with the human body are safe, effective, and meet global regulatory expectations.

The British Standards Institution (BSI) has published a revised standard to provide a framework to assess the biological safety of medical devices, ensuring materials that come into contact with the human body are safe, effective, and meet global regulatory expectations. 

First developed to bring scientific rigor and consistency to biocompatibility testing, the standard has evolved to reflect advances in material science, toxicology, and risk management. The sixth edition introduces significant updates, including alignment with the standard enhanced guidance on exposure duration, device characterisation, and biological hazard identification, and a new annexe explaining the rationale behind the revised biological effects tables.

“This revised standard reflects a new era in biological evaluation, one that is evidence-led, globally harmonised, and designed to support both patient safety and innovation,” said Michelly Kelly, chair of the National Committee for the Biological Evaluation of Medical Devices. 

“This revision strengthens the way manufacturers assess biological safety by encouraging data-driven evaluations that enhance patient and user protection, reduce unnecessary animal testing, and streamline global regulatory approval. It also supports innovation across emerging technologies such as combination products and wearables, helping organisations bring safe, effective, and compliant medical devices to market more efficiently,” she continued. 

The new BS EN ISO 10993-1 provides the general principles for biological evaluation of medical devices within a risk management process. It guides manufacturers in determining which tests are necessary based on the device’s nature, contact type, and duration, ensuring appropriate safety assessment while avoiding unnecessary testing.

This latest revision emphasises risk-based decision-making, harmonisation with regulatory frameworks, and the integration of toxicological and material science data to improve patient outcomes and streamline global compliance.