首页|血管介入导管的涂层牢固度评价方法的研究

血管介入导管的涂层牢固度评价方法的研究

扫码查看
目的 分析血管介入导管的涂层牢固度评价方法.方法 以一种穿刺扩张器为研究对象,分别进行模拟使用前、后的外观检查及微粒测试,并对样品进行摩擦力测试,评价该样品的涂层牢固度.结果 模拟使用前、后的样品外观均符合制造商要求;相较于使用前,模拟使用后样品各粒径下(≥10 μm、10~25 μm、25~50 μm)的微粒数分别增加了1.08倍、1.02 倍和3.43倍,且出现了≥50 μm的微粒;摩擦力测试显示,涂层平均摩擦力均≤0.2 N、平均摩擦系数均≤0.05,但其涂层稳定性(F2/F1 值)表明可能存在涂层脱落的风险.结论 外观检查、微粒测试和摩擦力测试是评价血管介入导管涂层牢固度性能的有效方法.
A Study on the Evaluation Method of Coating Firmness for Vascular Interventional Catheters
Objective To Analyze the evaluation method for coating firmness of vascular intervention catheters.Methods With a puncture dilator as the research object,visual inspection and particle testing were conducted before and after simulation use,and friction testing was performed on the sample to evaluate its coating firmness.Results The appearance of the samples before and after simulation use met the requirements of the manufacturer;Compared to before use,after simulation use for the sample,the number of particles at different particle sizes(≥10 μm,10-25 μm,25-50 μm)increased by 1.08 times,1.02 times and 3.43 times,respectively,and particles≥50 μm appeared.The friction test showed that the average friction force of the coating was≤0.2 N and the average friction coefficient was≤0.05,but the stability of the coating(F2/F1 value)indicated that there may be a risk of coating shedding.Conclusion Visual inspection,particle testing,and friction testing are effective methods for evaluating the firmness performance of vascular intervention catheter coatings.

Vascular interventional cathetersCoating firmnessEvaluation methodsVisual inspectionParticle testingTest of friction force

李冬梅、张亚娟

展开 >

苏州苏大卫生与环境技术研究所有限公司(江苏苏州 215153)

血管介入导管 涂层牢固度 评价方法 外观检查 微粒测试 摩擦力测试

2024

医疗装备
国家食品药品监督管理局北京医疗器械质量监督检验中心 北京市医疗器械检验所

医疗装备

影响因子:0.339
ISSN:1002-2376
年,卷(期):2024.37(7)
  • 1