摘要
中国人口老龄化速度的逐渐加快导致对助行器的需求加大。可靠性是助行器的重要属性之一,然而目前助行器的可靠性研究较少。该文以家用轮式助行器为例,对其展开故障模式、影响及其危害性分析。通过收集、整理和分析26种故障模式,得到影响其可靠性关键模块为坐姿-站姿转换系统。针对此关键模块,该文开展了故障数据的采集及分析,检验其寿命分布符合对数正态分布模型,该模块可靠寿命t_(0.9)的0.95置信下限为2489.4 h。该研究针对家用轮式助行器开展的可靠性分析可以为其他有源医疗设备的可靠性分析提供思路,并推动形成符合我国医疗器械监管法规要求的可靠性研究审评要点,供业界参考。
The gradual acceleration of the aging population in China has led to an increased demand for mobility aids,and the reliability of domestic wheeled walking-aid is one of their important attributes,but there is little research on the reliability of mobility aids.This paper conducts the failure mode,effects and criticality analysis on domestic wheeled walking-aid.By collecting,collating and analyzing the 26 failure modes,the key modules are the chassis and the lifting system.The key modules are obtained,and the failure data is analyzed to find out that the lifetime distribution model is log-normal and the 0.95 lower confidence limit for reliability life of product t_(0.9) is 2489.4 hours.The study aims to provide ideas for the reliability analysis of other active medical devices and calls for the formation of a reliability study review point for the industry that meets the requirements of Chinese medical device regulations.
作者
郑晨
吕炫汉
周祁杰
朱嘉伟
李亚球
杨雪鹤
ZHENG Chen;LYU Xuanhan;ZHOU Qijie;ZHU Jiawei;LI Yaqiu;YANG Xuehe(Center for Medical Device Evaluation,National Medical Products Administration,Beijing,100081;China Electronic Product Reliability and Environmental Testing Research Institute,Guangzhou,511370;Key Laboratory of Active Medical Devices Quality&Reliability Management and Assessment,Guangzhou,511370)
出处
《中国医疗器械杂志》
2024年第1期75-79,共5页
Chinese Journal of Medical Instrumentation
基金
广东省药品监督管理局科技创新项目(2021ZDB10)。
