Cytotoxicity Tests in the Biological Evaluation of Medical Devices

Abstract

Since the early sixties mammalian and human cell cultures have been used as sensitive tool in the biological evaluation of medical and dental materials and devices. The three main areas of interest for the application of cell culture tests are: cytotoxicity tests mutagenicity tests, and cell models for studying the interaction between device surface and surrounding tissue. Cytotoxicity tests are frequently used in the development, preclinical testing and quality assurance and are now subject to international standards. Based on the experience derived from testing more than 1000 medical and dental devices over a period of nine years some general remarks about cytotoxicity testing and examples of cytotoxicity test protocols are given.