FDA Biocompatability: The Guide to the ISO 10993 Standards

What is ISO 10993 and what is it used for?

ISO 10993 is a set of international standards for the biological evaluation of medical devices. These standards set a singular framework for the evaluation of a device’s biocompatibility, or biological veneration, which is a measure of its ability to exist in harmony with the tissues of the human body. Given that some materials produce a toxic or immune response when exposed to the body, it is essential that devices—particularly those that are permanently implanted into the body—be stringently evaluated for biocompatibility.