In Vitro Assessment of Cell and Tissue Compatibility

Abstract In vitro methods are a critical component in the biological safety assessment of medical devices as they provide valuable information on cell and tissue compatibility prior to preclinical and clinical studies. While such methods utilize simplified systems compared to the complex in vivo milieu, they are important because they provide insight into potential in vivo tissue and cellular responses. Many in vitro methods have been standardized through a global harmonization process. These standardized tests serve a key role in the biological safety evaluation of medical devices and materials. In this chapter of Biomaterials Science 4th Edition, the scientific basis for the most common in vitro tests is examined. Examples are also presented of specially applied in vitro techniques developed in response to a growing shift toward devices that combine drugs or biological agents to improve medical device therapies.