V.I. Sevastianov, N.V. Perova, I.A. Dovzhik

The factors that influence the biological safety of implants are analyzed, as well as the existing programs and methods of its evaluation per the national standard GOST R ISO 10993-99 - Medical devices. Biological evaluation of medical devices - introduced in Russia, harmonized in accordance with the international standard ISO 10993 in 1999. According to GOST R ISO 10993-99 the standard program of biological evaluation of implanted devices specifies the types of tests de-pending on term and conditions of their use. When choosing the evaluation program it is necessary to account for the nature of the device component materials, the correspondence of the device to its designated use considering the medical and technical properties of the materials used, and the most probable risk of implant application. The mandatory requirement for the medical and biological device evaluation is the preliminary analysis of chemical, physicochemical and phy-sicomechanical properties of the device components in order to identify the material and determine the degree of its chemical purity. It is demonstrated that the presence of the specific risk factors caused by the nature of the implant material calls to introduce to the biosafety evaluation program such additional tests as, for example, the activation of blood enzyme system, methods of accelerated testing of implant biodegradation, the cell culture cytotoxicity evaluation.