紫杉醇涂层球囊物理性能的测试方案

Test Plan for Physical Properties of Drug Coated Balloons

目的:确定药物涂层球囊的物理检测范围,确定紫杉醇带药球囊的物理性能,建立测试方法。方法:依据行业标准YY0285.4-2017《血管内导管一次性使用无菌导管第4部分:球囊扩张导管》,结合药物球囊的特性对球囊额定爆破压、球囊疲劳、球囊充盈及泄压时间、球囊与压力关系等测试方向进行分析考察并明确性能判定。结果:提出药物涂层球囊产品的物理性能测试方案,为同类产品的球囊力学检测提供技术支持。结论:药物涂层球囊的力学检测要结合常规球囊的方法综合考虑分析其临床应用,以符合标准规定要求及判定。

Objective:Determine the physical detection range of drug coated balloons,determine the physical properties of paclitaxel loaded balloons,and establish testing methods.Methods:Based on the industry standard YY0285.4-2017 Sterile Catheters for Single Use Intravascular Catheters-Part 4:Balloon Dilation Catheters,combined with the characteristics of drug balloons,the rated burst pressure,balloon fatigue,balloon filling and pressure relief time,and the relationship between balloons and pressure were analyzed and evaluated,and the basic performance judgment was clarified.Results:A physical performance testing plan for drug coated balloon products was proposed,providing technical support for mechanical testing of similar products.Conclusion:The mechanical testing of drug coated balloons should be combined with conventional balloon methods to comprehensively consider and analyze their clinical application,in order to meet the requirements and judgments of standard regulations.