首页|血管内导管润滑涂层性能评价方法研究

血管内导管润滑涂层性能评价方法研究

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针对血管内导管润滑涂层的稳定性、润滑性和完整性等关键性能,提出了不溶性微粒测试法、摩擦力测试法和外观检查法3种评价方法,并选取了 15批不同厂家生产的微导管进行试验,分析了 3种评价方法的试验原理、试验步骤、试验结果及特点,为带有润滑涂层的血管内导管的设计生产、评价及监管提供了参考.
Study on performance evaluation method for lubricating coatings of intravascular catheters
Three evaluation methods were recommended for the key properties of the intravascular catheter lubricating coating such as stability,lubricity and integrity,including insoluble particle test method,friction test procedure and appearance detection method.Fifteen batches of microcatheters produced by different manufacturers were selected for testing to clarify the three methods in test principle,step,result,characteristic.References were provided for the design,production,evaluation and regulation of intravascular catheters with lubricant coatings.[Chinese Medical Equipment Journal,2025,46(1):66-72]

intravascular catheterlubricating coatingperformance of lubricating coatinginsoluble particle test methodfriction dest procedureappearance detection method

陈洪建、艾冲冲、李元彧、黄丽萍、聂佳祺、王常斌、杨倩、毕宇欣、卢文博

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山东省医疗器械和药品包装检验研究院,国家药品监督管理局生物材料器械安全性评价重点实验室,山东省医疗器械生物学评价重点实验室,济南 250101

血管内导管 润滑涂层 润滑涂层性能 不溶性微粒测试法 摩擦力测试法 外观检查法

2025

医疗卫生装备
军事医学科学院卫生装备研究所

医疗卫生装备

影响因子:0.776
ISSN:1003-8868
年,卷(期):2025.46(1)