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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中振荡速率对浸提液溶出物的影响,本研究以国际标准ISO10993-12:2007中推荐的阳性标准物质(SPU-ZDEC)为试验样品,检测了不同振荡速度下浸提液的细胞毒性。结果表明,医疗器械生物学实验中不同的样品振荡速率对检测结果具有显著影响,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可靠的实验依据,有着重要的参考意义。
The standardization of test sample preparation in the biological evaluation of medical devices is the key to ensure the reliability and comparability of test results. In order to further clarify the influence of the oscillation rate on leachate leaching during the sample preparation, we used the SPU-ZDEC recommended in the international standard ISO10993-12: 2007 as the test sample, Extract cytotoxicity. The results show that the different sample oscillation rates in medical device biology experiments have a significant impact on the test results. This study provides a reliable experimental basis for the standardization of sample preparation in the future standard setting, which has important reference significance.