The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk.
These documents were preceded by the Tripartite agreement and is a part of the international harmonisation of the safe use evaluation of medical devices.
[1] For the purpose of the ISO 10993 family of standards, biocompatibility is defined as the "ability of a medical device or material to perform with an appropriate host response in a specific application".
If it is unclear in which category a device falls, consulting device-specific guidances or contacting the appropriate US Food and Drug Administration (FDA) review division for more information is possible.
The table "Endpoints to be addressed in a biological risk assessment" was revised by the 2018 edition of ISO 10993-1.