ISO 10993
At a glance: International standards for evaluating medical-device biocompatibility and biological risk.
ISO 10993 is a series of standards for evaluating the biocompatibility of medical devices as part of managing biological risk. Biocompatibility is the ability of a device or material to perform with an appropriate host response in a specific application. 55 Its cornerstone, ISO 10993-1, establishes the general principles for biological evaluation within a risk-management process and categorizes devices by the nature and duration of body contact. 56 The series covers endpoints including cytotoxicity, sensitization, irritation, and genotoxicity.