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Information × Registration Number 0224U000573, 0123U105129 , R & D reports Title Sanitary and epidemiological assessment: X-ray unit for blood irradiation Radgil 2 popup.stage_title Head Semashko Petro V., Доктор медичних наук Registration Date 09-01-2024 Organization State Institution "OM Marzeev Institute of Public Health of the National Academy of Medical Sciences of Ukraine" popup.description2 Object of examination X-ray unit for blood irradiation Radgil 2. Principle of operation: use of the ionizing ability of X-ray radiation to exert a bactericidal effect. Purpose: RADGIL2 is a medical device that uses X-rays to irradiate blood products contained in plastic bags when prophylaxis of TA-GvHD (transfusion-associated graft-versus-host disease) is indicated. According to the European Directive on the quality of medicinal products and health care, the Guide for the preparation, use and quality assurance of blood components, blood products should receive a dose of 25 Gy to 50 Gy in order to prevent TA-GvHD (graft-versus-host reaction, related to blood transfusion). RADGIL2 can also be used for NON-medical purposes, such as research. An analysis of the purpose, principle of operation, and basic technical characteristics of the product gives reason to believe that it is a source of the following potentially dangerous factors: ionizing radiation, EMF, EP 50 Hz, MP 50 Hz. Product Description popup.authors Bezverkha Anna Petrivna Semashko Petro V. popup.nrat_date 2024-01-09 Close