医疗器械体外细胞毒性试验不确定度评定  

Uncertainty Evaluation of In Vitro Cytotoxicity Tests for Medical Devices

作　　者：周晓萍 石志锋[1] 赵静[1] 李紫霖 覃锦红 徐昕荣[1] ZHOU Xiao-ping;SHI Zhi-feng;ZHAO Jing;LI Zi-lin;QIN Jin-hong;XU Xin-rong(Medical Devices Research&Testing Center,South China University of Technology,Guangdong Guangzhou 510006)

机构地区：[1]华南理工大学医疗器械研究检验中心,广东广州510006

出　　处：《中国医疗器械信息》2025年第5期30-33,共4页China Medical Device Information

基　　金：国家自然科学基金(项目名称:光响应电活性屏障膜材料抑菌抗炎及促进牙周再生研究,项目编号:U22A20160);国家重点研发计划项目(项目名称:生物适配型可降解镁合金硬组织植入器械产品研发,项目编号:2021YFC2400700)。

摘　　要：目的:对医疗器械体外细胞毒性试验检测过程进行不确定度评定。方法:以表面改性生物材料钛合金接骨板、牙种植体和椎间融合器为例,根据GB/T 16886.5-2017《医疗器械生物学评价第5部分:体外细胞毒性试验》,采用MTT法测定细胞存活率;并通过分析不确定度分量的来源,构建不确定度评定模型,对测量结果进行评定。结果:通过该法测定钛合金接骨板、牙种植体和椎间融合器所导致的细胞存活率分别为94.78%、98.79%、96.91%,扩展不确定度均为0.41%(k=2)。结论:仪器设备引入的不确定度分量大于测量重复性,在进行医疗器械体外细胞毒性检测过程中,必须使用经检定合格的仪器和设备进行试验操作;必要时可以增加试验重复次数来降低由测量重复性引入的不确定度,从而提高检测结果的准确性,同时也能为新型生物材料的开发和应用提供支撑依据。Objective:The uncertainty assessment of the detection process of in vitro cytotoxicity test of medical devices was carried out.Methods:Taking the titanium alloy bone plate of the surface-modified biomaterial as an example,according to GB/T 16886.5-2017“Biological Evaluation of Medical Devices Part 5:In Vitro Cytotoxicity Test”,the cell viability was determined by MTT method.By analyzing the source of the uncertainty component,the uncertainty evaluation model is constructed to evaluate the measurement results.Results:The cell viability rates of titanium alloy bone plates,dental implants and intervertebral fusion devices were 94.78%,98.79% and 96.91%,and all the expansion uncertainty was 0.41%(k=2).Conclusion:The uncertainty component introduced by instruments and equipment is greater than the measurement repeatability.In the process of in vitro cytotoxicity testing of medical devices,qualified instruments and equipment must be used for experimental operations.Necessarily,the number of test repetitions can be increased to reduce the uncertainty introduced by measurement repeatability,thereby improving the accuracy of detection results.At the same time,it can also provide support for the development and application of new biomaterials.

关 键 词：医疗器械 生物相容性 体外细胞毒性 不确定度 

分 类 号：R318[医药卫生—生物医学工程] Q256[医药卫生—基础医学]