BSI has launched a revised version of its internationally recognised standard for assessing the biocompatibility of medical devices, providing manufacturers and regulators with updated guidance on biological safety evaluation within a risk management framework.
The sixth edition, "Biological evaluation of medical devices – Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (BS EN ISO 10993-1:2025)", builds on the original aim of bringing scientific rigour and consistency to biocompatibility testing.
The updated standard reflects advances in material science, toxicology and regulatory practice, while supporting a more evidence-led and harmonised approach to compliance.
A key change in the 2025 revision is its full alignment with BS EN ISO 14971, the standard governing risk management for medical devices.
This integration reinforces risk-based decision-making and encourages manufacturers to make greater use of existing data, material characterisation and toxicological risk assessment when determining the need for additional biological testing.
The revised standard introduces enhanced guidance on exposure duration, clearer device categorisation based on the nature and length of body contact and improved clarity around the identification of biological hazards, now referred to as “biological effects”.
It also includes a new annexe explaining the rationale behind updates to the biological effects tables, aimed at improving transparency and consistency in evaluations.
Michelly Kelly, chair of CH/194, said: “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."
"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."
BS EN ISO 10993-1:2025 applies to all types of medical devices, including active, non-active, implantable and non-implantable products, throughout their lifecycle.
By strengthening the link between biological evaluation and risk management, the revised standard is intended to improve patient outcomes, support innovation and help organisations bring safe, compliant medical devices to market more efficiently.