Ready to raise the bar for medical device safety
The newly revised BS EN ISO 10993-1:2025 Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process helps you to establish a risk-based framework for assessing how your medical device materials interact with the human body. Its use gives you the clarity and confidence to demonstrate product compliance and protect your reputation in every market.
BS EN ISO 10993-1:2025 is the sixth edition of the standard and supersedes BS EN ISO 10993-1:2020 which will be withdrawn. This revision addresses industry needs for clearer, more consistent and scientifically justified biological evaluation, supporting both innovation and patient safety.
Who the standard is for:
- Medical device manufacturers – to ensure compliance and accelerate market access.
- Regulatory authorities – to provide a harmonized benchmark for evaluating biocompatibility.
- Testing laboratories – to establish clear, standardized protocols.
- Material and component suppliers – to understand biocompatibility requirements.
- Academic and research institutions – as a reference for developing new methodologies.
- Healthcare providers and clinicians – indirectly, by ensuring safer devices in clinical practice.
What's covered in the Executive Briefing?
- Benefits of using the standard.
- How to implement it.
- The challenges and how to overcome them.
- Next steps.
- Further reading and more.
Unlock the power of BS EN ISO 10993-1 by downloading the Executive Briefing:
To purchase the standard, find the standard on BSI Knowledge.
