Evaluation of biocompatibility using in vitro methods: interpretation and limitations.

The in vitro biocompatibility of novel materials has to be proven before a material can be used as component of a medical device. This must be done in cell culture tests according to internationally recognized standard protocols. Subsequently, preclinical and clinical tests must be performed to verify the safety of the new material and device. The present chapter focuses on the first step, the in vitro testing according to ISO 10993-5, and critically discusses its limited significance. Alternative strategies and a brief overview of activities to improve the current in vitro tests are presented in the concluding section.