Biocompatibility Testing

At STERIS AST, we help Customers develop risk-based test plans, demonstrate product safety, and accelerate global regulatory submissions by providing comprehensive biocompatibility testing services, including cytotoxicity testing, extractables and leachables testing, ISO 10993 biological evaluation support, and regulatory guidance. 

Biocompatibility testing helps medical device manufacturers identify, evaluate, and mitigate biological risks throughout the product lifecycle.  

Cytotoxicity testing, extractables and leachables (E&L) testing, and biological evaluation services are often performed early in product development to establish a baseline understanding of material safety, support risk assessments, and build an effective biocompatibility testing strategy.