基于FMEA方法的国产PET/MR失效分析研究

Failure Analysis of Domestic PET/MR with FMEA Method

我国国产高端医疗装备产业发展受可靠性问题制约严重。PET/MR是国际上最高端的医疗影像装备之一,研发高可靠性的国产PET/MR对实现进口替代、拓展国产装备市场至关重要。为保障国产PET/MR的可靠性,本研究在联影PET/MR设计研发过程中使用FMEA方法找出潜在的失效模式,建立PET/MR失效频度、探测度和失效后果严重度的评价标准,并对风险较高的失效模式提出改进措施。

The industry development of domestic high-end medical equipment is severely limited by poor reliability.PET/MR is one of the most high-end medical imaging equipment and the development of domestic PET/MR with high reliability is crucial to achieve import substitution and expand the market of domestic equipment.To guarantee the reliability of domestic PET/MR,this work used FMEA to identify the potential failure modes when the company of United Imaging designed and developed the equipment.This research also established the assessment criteria of failure severity,occurrence and detection and provided improvement measures for the failure modes with high risk.