New Revision ISO 10993-1:2025

The new revision is ISO 10993‑1:2025, published in November 2025. It is the 6th edition of the biocompatibility cornerstone standard and introduces a stronger risk‑based, lifecycle‑oriented approach.

🔑 Key Updates in ISO 10993‑1:2025

• Risk Management Integration: Biological evaluation must now be fully integrated into the ISO 14971 risk management framework. Testing is no longer a checklist; manufacturers must justify test selection or omission with scientific rationale.

• Exposure Definitions: New concepts of “contact day” and clarified rules for calculating exposure duration, including intermittent and repeated use devices. Bioaccumulation risks must be considered — if present, the device is treated as long‑term contact unless justified otherwise.

• Revised Contact Categorisation: Tables have been reorganized by tissue type: intact skin, mucosa, breached surfaces/internal tissue, and blood. This makes categorization clearer and more consistent.

• Material Characterisation: Greater emphasis on chemical and physical characterization as the first step in biological risk analysis. This supports scientific justification for reducing unnecessary animal testing.

• Expanded Toxicological Considerations: Genotoxicity and carcinogenicity requirements have been broadened. Pyrogenicity now only needs to be considered in suspected cases.

• Lifecycle Thinking: Evaluation must cover the entire device lifecycle — from design and manufacturing through use, re‑processing, storage, transport, and disposal. Any change in raw materials, sterilisation, or suppliers requires reassessment.

• Documentation Requirements: Stronger expectations for Biological Evaluation Plans (BEPs), Biological Evaluation Reports (BERs), and Risk Management Files (RMFs). Regulators will expect clear alignment with ISO 10993‑1:2025 principles.

  
  

📌 Implications for Manufacturers

• Conduct a gap analysis against the new edition.

• Update biological evaluation strategies to emphasize scientific justification and risk‑based decision making.

• Strengthen documentation to demonstrate lifecycle safety and regulatory readiness.

• Align biocompatibility evaluations with MDR/IVDR Annex I requirements for EU submissions.