ISO 10993-1:2025 is here – Are your biological evaluations ready?

The new edition of ISO 10993-1:2025 – Biological evaluation of medical devices introduces major changes, further strengthening alignment with ISO 14971 risk management and reshaping how biological safety must be demonstrated. 

Here are the key highlights: 

Full integration into risk management 

• Revised title aligned with ISO 14971 

• Clearer structure with well-defined requirements at each evaluation phase 

• Biological evaluation positioned as a continuous risk management activity 

Clearer exposure duration rules 

• Exposure duration standardised in calendar days 

• Real-life use scenarios are now critical when defining exposure 

Reasonably foreseeable misuse explicitly required
Manufacturers must consider how devices are actually used, not only how they are described in the IFU. These scenarios may significantly impact exposure classification, testing requirements, and biological risk. 

Updated approach to biological effects 

• “Biological endpoints” replaced by “biological effects” 

• Simplified contact categories (4 groups, “externally communicating” removed) 

• Reduced reliance on in vivo testing 

• Material-mediated pyrogenicity removed from the biological effects tables 

Key testing impacts 

• Systemic toxicity now addressed as a single biological effect 

• Genotoxicity required for prolonged and long-term contact devices (except intact skin) 

• Carcinogenicity added for long-term mucosal contact 

• “Local effects after tissue contact” replaces implant effects 

Biological Evaluation Plan (BEP) & Report (BER): reinforced expectations
The BEP and BER are now central, living documents that must clearly demonstrate: 

• Alignment with ISO 14971 

• Justification of testing strategies 

• Consideration of intended use and foreseeable misuse 

• Clear biological risk acceptability criteria 

• Robust conclusions on overall biological safety 

We support medical device manufacturers by: 

• Preparing Biological Evaluation Plans (BEP) and Biological Evaluation Reports (BER) fully compliant with ISO 10993-1:2025 

• Updating existing documentation from the 2018 to the 2025 edition 

• Supporting gap analyses and testing strategies 

If you are transitioning to ISO 10993-1:2025 or launching a new medical device, we can help ensure your biological evaluation is robust, compliant, and audit-ready. 

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