Radiation sterilization and volatile matter used for medical devices touching to blood

In this study, it was conducted by using chemical analysis and cell toxic test if any volatile matter actually on radiation, if any matter could be detected when its generating, if it stayed to a safe volume range, and so forth. Objective materials of this study focus the elements used for medical devices always touching blood having large effect on human bodies. In this fiscal year, because of many cases of sterilization after filling water and necessary gas-liquid equilibrium for quantitative method using a head space when actually using the materials for dialyzer, irradiation was conducted after filling water into the material, comparison of gas volume and evaluation of safety with those of conventional experiments. As a result, by γ-ray irradiation, various matters are formed, and some volatile matters less than some ng level in present volume could be detected. However, from a standpoint of safety data and forming volume of the cell toxic test results, there were no matter anxious to safety. Furthermore, the present dialyzer and others are washed before using chemically, and its safety seems to be fully held. (G.K.)