ISO 10993-1:2025 – Biological evaluation of medical devices. Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
ISO 10993-1:2025 has recently been published, introducing important updates to the cornerstone standard for the biological evaluation of medical devices. ISO 10993-1 plays a critical role in defining the principles and requirements for assessing the biological safety of medical devices within the broader risk management framework established by ISO 14971. The standard guides manufacturers and ...
