FMECA and Failure Data Analysis of Domestic Wheeled Walking-Aid
10.3969/j.issn.1671-7104.230397
- VernacularTitle:基于家用轮式助行器的FMECA及其失效数据分析
- Author:
Chen ZHENG
1
;
Xuanhan LYU
;
Qijie ZHOU
;
Jiawei ZHU
;
Yaqiu LI
;
Xuehe YANG
Author Information
1. 国家药品监督管理局医疗器械技术审评中心,北京市,100081
- Keywords:
walking-aid;
reliability;
failure mode effects and criticality analysis;
failure data analysis
- From:
Chinese Journal of Medical Instrumentation
2024;48(1):75-79
- CountryChina
- Language:Chinese
-
Abstract:
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 t0.9 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.
