ISO 10993-1 is the foundational standard for the biological evaluation of medical devices within a risk management process. It specifies the general principles for assessing the biological safety of medical devices that come into contact with the body.
The latest revision, ISO 10993-1:2025, significantly strengthens the risk-based approach and integrates the standard more closely with the broader medical device risk management standard, ISO 14971.
ISO 10993-1:2025 moves further away from simple prescriptive testing based on a matrix and towards a science-driven, risk-based approach where comprehensive chemical characterization and toxicological risk assessment are the first, crucial steps in demonstrating a device’s biocompatibility.
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