According to the Polish Ministry of Health decree, the medical devices and all raw materials used for their manufacturing are in force to be compatible with biological tissues, cells and body fluids regarding its clinical use. It is defined as biocompatibility. The scope of the methods proposed in the norm PN-EN ISO 10993-1 makes possible to get full preclinical characteristics of the medical device and allows to form the opinion about safety of it to the patients after its marketing. The test directed as the principal to make, independently on characteristics, kind, contact duration and clinical use of the device is cytotoxicity in vitro. This test defines the impact of the device on the cells through microscopic evaluation or through activities of the enzymes specific for living cells. Toxicity of the material to the cells may be reflected in: change of single cells or whole cell culture morphology, change of cellular metabolic activity, DNA damage or disadvantage of cell proliferation. Biocompatibility of the medical devices is one of the main elements considered in a risk management process at the stage of designing and manufacturing as well of the raw materials as the final product and the critical point in this matter is sterilization.
Keywords: medical devices; biocompatibility; cytotoxicity in vitro.