Updated standard for medical devices biocompatibility testing

In November 2025, a new version of ISO 10993-1:2025 has been published. ISO 10993-1:2025 is the standard for the biological evaluation of medical devices, which includes the requirements and general principles for the evaluation of biological safety within a risk management process. This is the sixth edition of this standard and has been revised to align with ISO 14971 (medical devices’ risk management).

Biocompatibility testing of medical devices

The EU Medical Devices Regulation (MDR) sets requirements for manufacturers to test the biocompatibility of their device, including the identification of all materials in direct or indirect contact with the patient or user.

ISO 10993 is the key standard for manufacturers, designers, and evaluators of medical devices that come into direct or indirect contact with the body. Among others, this should be used for implantable, surface-contacting, and externally communicating devices, as well as protective equipment such as gloves and surgical masks. Biocompatibility testing consists of assessing how materials and medical device interact with biological tissues.