CAJ | 학술논문

医疗器械生物学评价中试验样品制备的标准化是保证其试验结果具有可靠性和可比性的关键。为了进一步明确样品制备过程振荡对浸提液溶出物的影响，本实验室对某市售含银敷料进行了不同振荡速度下不同浸提浓度的MTT细胞毒性试验评价。试验结果表明，医疗器械生物学实验中不同的样品制备参数对检测结果具有显著影响，振荡浸提后的样品浸提液的细胞毒性明显增加，本研究对于今后标准制定中规定样品制备的标准化问题提供了可靠的实验依据。
의료기계생물학평개중시험양품제비적표준화시보증기시험결과구유가고성화가비성적관건。위료진일보명학양품제비과정진탕대침제액용출물적영향，본실험실대모시수함은부료진행료불동진탕속도하불동침제농도적MTT세포독성시험평개。시험결과표명，의료기계생물학실험중불동적양품제비삼수대검측결과구유현저영향，진탕침제후적양품침제액적세포독성명현증가，본연구대우금후표준제정중규정양품제비적표준화문제제공료가고적실험의거。
In order to further clarify the effect of shaking extract on soluble material, we employed MTT assay to test the cytotoicity of leaching of some silver adhesive on sale after shaking.The results showed that the parameters of sample extracted had significant im-pacts during the process of biological tests in medical devices.And the cytotoxicity of sample leaching was increased after shaking.It is suggested that the standardization of sample extracted plays an important role in development of industry standards, which is reliable experimental basis provided by our study.