ISO 10993-1:2025 Biological Evaluation of Medical Devices – Edition 6 Update

The ISO 10993-1:2025 standard (Edition 6) for the biological evaluation of medical devices introduces a risk-based, lifecycle approach to assessing biological safety. Published in November 2025, it replaces the prescriptive Table A1 from ISO 10993-1:2018 and aligns closely with ISO 14971 for risk management. Manufacturers now focus on identifying and mitigating actual biological hazards rather than following a checklist of required tests.

Key Updates in ISO 10993-1:2025

The sixth edition has been completely reorganized to enhance clarity and integration with risk management:

• Alignment with ISO 14971: Biological evaluation is now explicitly integrated into the overall risk management process.

• Updated terminology: Terms are clarified to reduce misinterpretation across stakeholders.

• New guidance: Includes considerations for exposure duration, materials characterization, and hazard identification.

• New annexes: Explain the rationale behind changes and support consistent application by manufacturers and regulators.

• Transition from Table A1: The old prescriptive table is replaced by four separate tables emphasizing risk-based evaluation, moving away from a check-box approach.

What Changed from ISO 10993-1:2018?

The most significant shift in ISO 10993-1:2025 is how biological safety testing is approached:

• End of the Table A1 approach: Previously, Table A1 listed required tests by device category, contact type, and exposure duration. This approach is now replaced by a risk-based framework.

• Lifecycle-based evaluation: Manufacturers should ask, “What biological safety risks does our device actually present?” instead of “Which tests are mandatory?”

• Split into four tables: The new structure better addresses diverse device types and contact scenarios, encouraging comprehensive safety assessments rather than minimum compliance.

• Focus on scientific justification: Test selection now depends on material characteristics, intended use, and hazard identification, not just device classification.

Implications for Medical Device Manufacturers

ISO 10993-1:2025 affects regulatory submissions and internal testing strategies:

• Enhanced integration with risk management: Safety evaluation is part of overall ISO 14971 compliance.

• More flexibility and responsibility: Sponsors must provide scientific justification for each biological test performed.

• Potential regulatory adaptation: EN ISO version is expected soon, which will harmonize requirements across the EU.

• Early planning essential: Companies should update protocols, dossiers, and testing strategies to align with the risk-based evaluation model.

Action Steps for Compliance

Manufacturers should consider the following actions:

1. Review ISO 10993-1:2025 thoroughly and understand the four new tables.

2. Map biological hazards to device lifecycle and exposure scenarios.

3. Update risk management files to reflect the integrated approach with ISO 14971.

4. Justify all selected tests scientifically, focusing on device-specific risks rather than generic checklists.

5. Monitor EN ISO publication to align EU regulatory compliance with the new ISO version.

External links

• ISO 10993-1:2025 Official Standard  

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