Abstract
The aim of this study was to assess blood compatibility and genotoxicity of a femoral prosthesis sterilization by radiation, so as to evaluate the safety of radiation as a method of sterilization of these materials. We detected hemolysis rate to preliminarily assess the blood compatibility of the radiation sterilized femoral prosthesis. Genotoxicity were checked by a combined use of chromosome aberration test and Ames test; a series of performance tests of packaging material were also conducted to detecte whether radiation has any effect on physicochemical properties of packaging material. Haemolysis test show that the haemolysis rate of the test samples is 1.4% (<5%), which is coincidence with the criteria of the medical devices.After the irradiation and tests of packaging material, the sample materials and the package remained effective, the device remained sterile, and no adverse responses were detected in genotoxicity tests.
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Chen, G., Liu, Q., Liu, W. (2011). In Vitro Evaluation on the Effect of Radiation Sterilizion on Blood Compatibility and Genotoxicity of a Femoral Prosthesis. In: Liu, C., Chang, J., Yang, A. (eds) Information Computing and Applications. ICICA 2011. Communications in Computer and Information Science, vol 244. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-27452-7_18
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DOI: https://doi.org/10.1007/978-3-642-27452-7_18
Publisher Name: Springer, Berlin, Heidelberg
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