目的 探讨不同灭菌方式对4种医疗器械或材料细胞毒性评价结果的影响。方法 采用浸提液法和MTT法2种细胞毒性方法对4种常用医疗器械和材料(一次性使用医用口罩、一次性使用多功能手术解剖器(镊体)、注射用冷冻干燥用氯化丁基橡胶塞和一次性使用输液器)在不同灭菌方式(紫外辐照灭菌、高温湿热灭菌、环氧乙烷灭菌)后的细胞毒性进行测定。结果 一次性使用医用口罩、一次性使用多功能手术解剖器(镊体)、注射用氯化丁基橡胶塞在3种灭菌条件下细胞毒性分级均为1级,细胞存活率均＞70%;一次性使用输液器在紫外辐照灭菌和高温湿热灭菌方式下细胞毒性分级均为1级,细胞存活率均＞70%,环氧乙烷灭菌条件下细胞毒性分级为2级,细胞存活率＜70%。结论 医疗器械或材料的灭菌方式会影响其细胞毒性结果的测定,根据产品理化性质和材料的不同,应选择适宜的灭菌方式。尤其多组分、多材料,涉及各种添加剂的器械产品,在进行细胞毒性试验时一定要根据产品的特性或与其临床使用灭菌方式保持一致。

Objective To explore the impact of different sterilization methods on the cytotoxicity evaluation results of four medical devices or materials. Methods The extraction method and methyl thiazolyl tetrazolium (MTT) method were used to determine the cytotoxicity of four commonly used medical devices and materials [disposable medical masks,disposable multifunctional surgical dissectors (forceps),injection freeze-drying chlorinated butyl rubber stoppers,and disposable infusion sets] after different sterilization methods (ultraviolet irradiation sterilization,high-temperature and humid heat sterilization,and ethylene oxide sterilization). Results The disposable medical masks,disposable multifunctional surgical dissectors (forceps),and injection chlorinated butyl rubber stoppers all had a cytotoxicity grade of 1 under three sterilization conditions,and the cell survival rates were all above 70%.The cytotoxicity grade of disposable infusion sets under ultraviolet irradiation sterilization and high-temperature and humid heat sterilization methods was grade 1,and the cell survival rate was greater than 70%.Under the condition of ethylene oxide sterilization,the cytotoxicity grade was 2,and the cell survival rate was less than 70%. Conclusion The sterilization method of medical devices or materials can affect the determination of their cytotoxicity results.Depending on the physical and chemical properties of the product and the different materials,an appropriate sterilization method should be selected.Cytotoxicity tests must be carried out in accordance with the characteristics of the product or its clinical sterilization method.Especially for equipment products with multiple components,materials,and involving various additives.