首页|医疗器械用压敏胶的生物学危害及安全风险研究

医疗器械用压敏胶的生物学危害及安全风险研究

扫码查看
目的 研究不同类型的医疗器械用压敏胶的生物相容性,为压敏胶的规范使用提供理论支撑。方法 按参照GB/T 16886医疗器械生物学评价标准,对不同类型的医疗器械用压敏胶进行细胞毒性试验、中性红摄取试验、溶血试验和凝血试验等生物相容性评价试验研究。结果 YP1、YP3和YP4在厚度40μm时细胞存活率<70%,YP1、YP3和YP4在20μm和40μm厚度时中性红吞噬率均下降超过50%,YP3和YP4在10μm、20μm和40μm 厚度时的溶血率均>5%,YP3和YP4在厚度20μm和40μm时的PTT值与空白对照相比的百分比均<80%。结论 在本次试验条件下,部分厂家的丙烯酸酯压敏胶,尤其是YP3和YP4,在一定厚度时具有潜在细胞毒性,抑制细胞的吞噬功能,具有溶血反应和凝血反应,在医疗器械的使用时应慎重考虑。
Study on the biological hazards and safety of pressure sensitive adhesive for medical devices
Objective To evaluate the biocompatibility of different types of pressure sensitive adhesive for medical devices,which provides theoretical support for scientific supervision of the pressure-sensitive adhesive.Methods Based on a series of GB/T 16886 medical equipment biology evaluation standards,Pressure sensitive adhesive for medical devices were subjected to a series of tests,including MTT cytotoxicity test in vitro,neutral red uptake test,and hemocompatibility test and Partial thromboplastin time.Results The cell survival rates of the YP3 and YP4 were less than 70%at 40μm thicknesses,The neutral red phagocytosis rates of theYP1,YP3 and YP4 were reduced to<50%of the blank.at thicknesses of 20μm and 40μm.The hemolysis rates of theYP1,YP3 and YP4 were more than 5%at thicknesses of 10μm,20μm and 40μm.The partial thromboplastin time of YP3 and YP4 compared with blank control were less than 80%at thicknesses of 20μm and 40μm.Conclusion Under the current test conditions,the acrylic emulsion pressure sensitive adhesive showed a potential biocompatibility with potential cytotoxicity,inhibition of cellular phagocytic functionhemolytic effect and blood coagulation effect,especially for YP3 and YP4 at some thicknesses.

Pressure sensitive adhesiveMedical devicesBiological compatibilityThickness

叶小惠、周宙、张磊、章亚兵、施超、黎秀梅、吕彤彤、王彦蕲

展开 >

安徽省食品药品检验研究院生物学评价检测室,合肥 230051

安徽省科技成果转化促进中心科技研发部,合肥 230091

压敏胶 医疗器械 生物相容性 厚度

2024

现代仪器与医疗
中国科学器材公司

现代仪器与医疗

影响因子:1.47
ISSN:2095-5200
年,卷(期):2024.30(6)