What is BS EN ISO 10993-1:2025 about?
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 is the internationally recognized standard for the biological evaluation of medical devices. It establishes a risk-based framework for assessing how medical device materials interact with the human body, focusing on safety and biological response.
The standard guides you through material characterization, toxicological risk assessment and the selection of appropriate biological tests, ensuring that medical devices are safe for patients and users throughout their lifecycle.
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Who is BS EN ISO 10993-1:2025 for?
BS EN ISO 10993-1:2025 is intended for a broad range of stakeholders in the medical device sector, including:
- 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 does BS EN ISO 10993-1:2025 cover?
BS EN ISO 10993-1:2025 covers:
- The general principles for biological evaluation within a risk management process.
- Categorization of devices based on the nature and duration of body contact.
- Evaluation of existing data and identification of gaps.
- Guidance on additional data and tests needed for biological safety.
- Assessment of risks arising from material changes, device breakage, or exposure to new materials.
- Applicability to all types of medical devices, including active, non-active, implantable and non-implantable devices.
- Excludes hazards related to microbiological agents (such as bacteria and viruses).
Why should you use BS EN ISO 10993-1:2025?
Using BS EN ISO 10993-1:2025 enables you to:
- Demonstrate compliance with global regulatory requirements, facilitating market access.
- Ensure patient and user safety by systematically addressing biological risks.
- Streamline regulatory reviews and reduce the risk of product recalls.
- Support innovation through a flexible, risk-based approach.
- Reduce unnecessary animal testing by prioritising data-driven decisions.
- Build trust with regulators, healthcare professionals, and end users by adhering to a globally harmonized standard.
What's changed?
BS EN ISO 10993-1:2025 is the sixth edition of the standard and supsedes BS EN ISO 10993-1:2020 which will be withdrawn. This revision introduces several significant updates:
- Complete reorganisation and alignment with the risk management framework of BS EN ISO 14971.
- Enhanced guidance on calculating exposure duration and device characterization.
- Improved clarity on identifying biological hazards and effects (now referred to as “biological effects” rather than “end points”).
- Updated terminology to reflect specific tissue contact and local effects after tissue contact.
- Annex A revised to focus on materials characterisation, with other content integrated into the main text.
- New Annex B explaining the rationale for changes to biological effects tables.
- Overall, the revision addresses industry needs for clearer, more consistent and scientifically justified biological evaluation, supporting both innovation and patient safety.
Find out more about BS EN ISO 10993-1:2025
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