Biocompatibility Testing

Biocompatibility Testing is the regulated evaluation to confirm that a medical device or its materials do not produce harmful biological responses when in contact with the human body. It supports regulatory submissions by proving safety for intended use. Globally, the ISO 10993 series define how to assess biological interactions and risks for devices that contact skin, tissue, blood, or bodily fluids. The FDA endorses ISO 10993-1 and provides guidance on using a risk-based approach to determine which tests are needed for premarket submissions. 
 
Typical endpoints include cytotoxicity (cell viability), irritation, sensitization, and other tests selected based on exposure route and duration. Failure to adequately assess biocompatibility blocks regulatory approval and market entry.