Navigate the ISO 10993-1 Updates with Confidence

Need help building a strategy around the ISO 10993-1 update?

The newly published ISO 10993-1:2025 introduces the most significant updates in decades—reshaping how medical device teams plan, document, and justify biocompatibility.

These updates can provide opportunities to strengthen your science, streamline your testing, and accelerate approvals. Having the right experts on your team can help you navigate the changes and come out ahead.

What’s Changed with the ISO 10993-1 Revisions?

More Comprehensive, Risk-Based Evaluations

The revised ISO 10993-1 reinforces alignment with ISO 14971, emphasizing evidence-driven evaluations over a check box testing approach.
Reworking historical biological evaluation paradigms and ensuring alignment with overall device risk management frameworks will be key to meeting regulatory expectations.

Refined Device Categorization & Contact Time

Revised definitions for contact type and methods for calculating duration of exposure can shift devices into higher-risk categories which result in increased testing requirements for genotoxicity and systemic toxicity.
Even brief or repeated exposures, or residues that persist, now count toward longer contact durations, requiring updated Biological Evaluation Plans.

Clearer Guidance on Particulates

Particulates are now a key risk factor, with regulators expecting clear differentiation between manufacturing residues and particles from wear or degradation.
Integrate engineering and toxicology insights to ensure your evaluation holds up under regulatory scrutiny.

Greater Focus on End-of-Life Evaluations

Updated emphasis on understanding a device’s full life cycle, including how materials and performance may change over time.
Biological risks must be evaluated not only at the point of manufacture, but also after simulated aging, repeated use, or exposure to sterilization and cleaning processes.

Why It Matters Manufactures who strategically plan
around these changes can:

Build stronger, evidence-driven for Biological Evaluation Plans (BEPs)
Avoid unnecessary testing and accelerate regulatory submissions
Strengthen collaboration between materials, engineering, and toxicology teams
Reduce risk of delays and rejections with robust scientific justification

Get Guidance in Navigating ISO 10993 Updates

Nelson Labs’ Expert Advisory Services works directly with standards committees and regulatory agencies, helping device teams translate requirements into defensible strategies.

Fill out the form to connect with our advisory experts and discuss your next steps under the updated ISO 10993-1 framework.

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Resources

Learn more about how ISO 10993-1 revisions will impact your evaluations.

On-Demand Webinars

ISO 10993-1 Panel Discussion: Preparing for Updates in the New FDIS

ISO 10993-1 is a foundational standard for the biological evaluation of medical devices, guiding how manufacturers assess safety and meet global regulatory requirements. With the new version published in November...

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