New ISO 10993-1:2025 Standard for Medical Device Biological Evaluation Released
21 November 2025
ISO 10993-1 is the cornerstone standard for biological evaluation of medical devices. It defines the principles and requirements for assessing a device’s biological safety within the broader risk management framework established by ISO 14971.
The standard guides manufacturers and evaluators through the process of identifying, assessing, and managing biological risks associated with materials, design choices, and tissue contact during a device’s intended use.
What is new?
- The standard is reorganised and now aligns very closely with ISO 14971 (risk management for medical devices).
- Exposure definitions: There is new notion of “contact day” and clarified rules for calculating exposure duration (especially devices with repeated or intermittent use) and for devices with potential bioaccumulation risk.
- Device contact categorisation has been revised: the tables that correlated contact type and duration have been reconstructed into separate tables for different tissue contact types:
- intact skin;
- intact mucosa;
- breached surface or internal tissue;
- blood.
- Material characterisation (chemical/physical) is emphasised as part of biological risk analysis.
- The cases in which genotoxicity and carcinogenicity must be considered have been expanded. Pyrogenicity now only needs to be considered in suspected cases.
- The importance of life-cycle thinking has increased, from design to disposal, including re-processing, storage, transport, degradation.
With the release of ISO 10993-1:2025 (edition 6), the biological evaluation of medical devices presents challenges that need to be addressed. The updated standard moves decisively towards a scientifically justified, risk-based, and lifecycle-oriented approach that demands strong alignment with ISO 14971. This raises expectations – and new opportunities – for manufacturers to strengthen the safety and regulatory readiness of their devices.
As specialised experts in biocompatibility and biological safety, we help manufacturers navigate this transition smoothly and efficiently. Reach out and learn how we can help you!
