摘要
心血管支架是治疗冠状动脉硬化的重要医疗器械之一,其质量与疾病的康复和人民的健康息息相关,而心血管支架材料作为心血管支架的制造基础,其质量的好坏决定了心血管支架的质量和临床使用风险,因此对心血管支架材料进行检验具有十分重要的意义。本文根据笔者工作实践,对心血管支架材料检测的重要意义、心血管支架材料检验方法及质量技术标准进行了探讨。
Cardiovascular stent is one of the most important medical devices for the treatment of coronary atherosclerosis.The rehabilitation of coronary atherosclerosis is closely related to the quality of cardiovascular stent.As the manufacturing basis of cardiovascular stent,the composited material of the cardiovascular stent determines the quality of cardiovascular stent and the result of clinical use,so it is critical to perform safety and effectiveness test of cardiovascular stent material before clinical trials.According to the author’s work practice,this paper discusses the significance of the detection of cardiovascular stent materials,the inspection methods and quality technical standards.
作者
程静
林祥德
廖越华
姚天平
CHENG Jing;LIN Xiang-de;LIAO Yue-hua;YAO Tian-ping(School of Medical Instrument,Shanghai University of Medicine&Health Science;Shanghai Inspection and Testing Institute for Medical Devices)
出处
《中国标准化》
2020年第S01期175-180,共6页
China Standardization
关键词
心血管支架
生物材料
标准体系
cardiovascular stent
biomaterial
standards system
