ABSTRACT
The selection and evaluation of materials and devices intended for use in humans requires a method of assessment to establish biocompatibility and safety and should be conducted within the framework of a risk management process. Biological characteristics need to consider the intended clinical use of the device, the duration of contact and the intended contact. Biocompatibility testing should be designed to assess the potential adverse effects under actual use conditions or specific conditions close to the actual use conditions. The physical and biological data obtained from biocompatibility tests should be correlated to the device and its intended use. There are many cytotoxicity test methods available for testing biomaterials. These tests can be divided into three categories: tests using extracts, direct contact tests, and indirect-contact tests. Extracts of test devices and materials are tested by exposure to the cell culture. The presence of cytotoxic leachates is indicated by loss of cell viability.
