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  • 學位論文

醫療器材體外細胞毒性測試平台之建立

Plateform development of In vitro Cytotoxicity Testing for Medical Devices

指導教授 : 蘇俊魁 張炎林

摘要


凡是接觸人體之醫療器材都必須通過體外細胞毒性評估。而奈米材料近年來被廣泛地運用於醫療器材的開發,而本研究根據國際標準組織(ISO)及美國試驗與材料協會(ASTM)兩大組織之相關標準去歸納與整合,其中包括奈米材料及非奈米材料去建立體外細胞毒性測試平台,並實際試驗,試驗材料選用已上市材料紅血球專用去白血球過濾器(RCXL1Y, PALL)及奈米銀粒子,實驗結果RCXL1Y為無細胞毒性與預期結果相符。奈米銀試驗結果則發現干擾的現象導致假性的結果,並不是標準中的試驗方法一定適用於奈米材料,因此在使用標準時應注意試驗結果是否有無干擾情形,以確保毒性判讀的正確性。未來在開發醫療器材時可依據本研究所建立的平台做測試,以促進醫療器材產業之發展。

並列摘要


Medical device that contacts with human body has to evaluate safety of in vitro cytotoxicity . In recent years, nanomaterials are used widely in the field of medical devices. In this study, we used nanomaterials and non-nanomaterials to establish an in vitro cytotoxicity test platform which was according to the relevant standards of the International Organization for Standardizations (ISO) and The American Society for Testing and Materials (ASTM). We selected the listed product “High Efficiency Leukocyte Removal Filter For Red Cell Transfusion (RCXL1Y)” and “nanosilver particle” to test the above platform. The result of RCXL1Y cytotoxicity test was non-cytotoxic. However, as the result of nanosilver, it appeared interference phenomenon that led to false result. We found that the test methods of standards were not suitable for all nanomaterials. Therefore, using test methods of standards should notice interference conditions to ensure the correction of results. In the future, this study about in vitro cytotoxicity testing platform can be used in developing medical devices to promote progress in the industry.

參考文獻


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