Evaluation of the Biological Effect of Medical Devices: General Requirements for Biological Safety (Analytical Review)

The main goal of the article is to familiarize specialists working in the field of medical devices (MDs) with existing approaches to the study of their biocompatibility, set out in the standards of the GOST (State Standard) ISO 10993 series. The concept of the GOST (State Standard) ISO 10993 series of standards lies in establishing the biological safety and functional effectiveness of MDs in the terms of biological risk, as necessary and sufficient conditions for biocompatibility of MDs in clinical application. The main attention in the general scheme of assessing the biological safety of MD is paid to the program of toxicological studies (tests), consisting of a set of methods that take into account the category, purpose, and duration of MD functioning.