近年来,随着国家对高风险医疗器械不良事件重点监测工作的深入开展,不良事件监测风险分析方法的多样化需求日益迫切。本文首次探索医疗器械导尿管类产品上市后,在不良事件监测中建立失效模式和效应分析(Failure Modes and Effects Analy...近年来,随着国家对高风险医疗器械不良事件重点监测工作的深入开展,不良事件监测风险分析方法的多样化需求日益迫切。本文首次探索医疗器械导尿管类产品上市后,在不良事件监测中建立失效模式和效应分析(Failure Modes and Effects Analysis,FMEA)模型,并通过监测近两期14家重点监测点的临床数据,获取FMEA模式在导尿管产品不良事件监测中应用的可行性,为FMEA在无源类医疗器械,甚至整个医疗器械类产品上市后不良事件监测中的推广应用提供了参考。展开更多
针对城市轨道交通(简称“城轨”)项目信号系统与站台门系统间易发联动故障,导致乘客人身安全隐患的问题,文章以长沙某轨道交通线路信号系统与站台门系统之间的接口为例,详细阐述了各子系统的失效模式;并采用基于功能失效模式及影响分析(...针对城市轨道交通(简称“城轨”)项目信号系统与站台门系统间易发联动故障,导致乘客人身安全隐患的问题,文章以长沙某轨道交通线路信号系统与站台门系统之间的接口为例,详细阐述了各子系统的失效模式;并采用基于功能失效模式及影响分析(failure modes and effects analysis,FMEA)的方法分析了该接口各种失效情况对列车运营的影响,给出了明确的信号系统安全需求和站台门系统安全需求分析结论;同时,针对后续新线建设给出了信号系统与站台门系统接口危害减缓措施,为轨道交通运营安全提供保障。展开更多
介绍了针对巨型起重船电力系统(large crane vessel's power system,LCVPS)实施故障模式影响分析(failure modes and effects analysis,FMEA)的具体方法,并按照系统级与设备级依次展开FMEA研究。分析了巨型起重船电力系统发电、配...介绍了针对巨型起重船电力系统(large crane vessel's power system,LCVPS)实施故障模式影响分析(failure modes and effects analysis,FMEA)的具体方法,并按照系统级与设备级依次展开FMEA研究。分析了巨型起重船电力系统发电、配电、起重各功能模块及模块中实现功能的具体设备的潜在故障模式、发生故障的原因、故障对局部及全局的影响等。运用Matlab软件对巨型起重船电力系统建模及故障仿真分析,以获得定量的故障数据,以便采取有效措施尽快消除故障,提高系统的可靠性。展开更多
Reliability allocation of computerized numerical controlled（CNC）lathes is very important in industry.Traditional allocation methods only focus on high-failure rate components rather than moderate failure rate compon...Reliability allocation of computerized numerical controlled（CNC）lathes is very important in industry.Traditional allocation methods only focus on high-failure rate components rather than moderate failure rate components,which is not applicable in some conditions.Aiming at solving the problem of CNC lathes reliability allocating,a comprehensive reliability allocation method based on cubic transformed functions of failure modes and effects analysis（FMEA）is presented.Firstly,conventional reliability allocation methods are introduced.Then the limitations of direct combination of comprehensive allocation method with the exponential transformed FMEA method are investigated.Subsequently,a cubic transformed function is established in order to overcome these limitations.Properties of the new transformed functions are discussed by considering the failure severity and the failure occurrence.Designers can choose appropriate transform amplitudes according to their requirements.Finally,a CNC lathe and a spindle system are used as an example to verify the new allocation method.Seven criteria are considered to compare the results of the new method with traditional methods.The allocation results indicate that the new method is more flexible than traditional methods.By employing the new cubic transformed function,the method covers a wider range of problems in CNC reliability allocation without losing the advantages of traditional methods.展开更多
文摘近年来,随着国家对高风险医疗器械不良事件重点监测工作的深入开展,不良事件监测风险分析方法的多样化需求日益迫切。本文首次探索医疗器械导尿管类产品上市后,在不良事件监测中建立失效模式和效应分析(Failure Modes and Effects Analysis,FMEA)模型,并通过监测近两期14家重点监测点的临床数据,获取FMEA模式在导尿管产品不良事件监测中应用的可行性,为FMEA在无源类医疗器械,甚至整个医疗器械类产品上市后不良事件监测中的推广应用提供了参考。
文摘针对城市轨道交通(简称“城轨”)项目信号系统与站台门系统间易发联动故障,导致乘客人身安全隐患的问题,文章以长沙某轨道交通线路信号系统与站台门系统之间的接口为例,详细阐述了各子系统的失效模式;并采用基于功能失效模式及影响分析(failure modes and effects analysis,FMEA)的方法分析了该接口各种失效情况对列车运营的影响,给出了明确的信号系统安全需求和站台门系统安全需求分析结论;同时,针对后续新线建设给出了信号系统与站台门系统接口危害减缓措施,为轨道交通运营安全提供保障。
文摘介绍了针对巨型起重船电力系统(large crane vessel's power system,LCVPS)实施故障模式影响分析(failure modes and effects analysis,FMEA)的具体方法,并按照系统级与设备级依次展开FMEA研究。分析了巨型起重船电力系统发电、配电、起重各功能模块及模块中实现功能的具体设备的潜在故障模式、发生故障的原因、故障对局部及全局的影响等。运用Matlab软件对巨型起重船电力系统建模及故障仿真分析,以获得定量的故障数据,以便采取有效措施尽快消除故障,提高系统的可靠性。
基金Supported by National Natural Science Foundation of China(Grant Nos.51135003,51205050,U1234208)Key National Science & Technology Special Project on"High-Grade CNC Machine Tools and Basic Manufacturing Equipments"(Grant No.2013ZX04011011)+1 种基金Research Fund for the Doctoral Program of Higher Education of China(Grant No.20110042120020)Fundamental Research Funds for the Central
文摘Reliability allocation of computerized numerical controlled（CNC）lathes is very important in industry.Traditional allocation methods only focus on high-failure rate components rather than moderate failure rate components,which is not applicable in some conditions.Aiming at solving the problem of CNC lathes reliability allocating,a comprehensive reliability allocation method based on cubic transformed functions of failure modes and effects analysis（FMEA）is presented.Firstly,conventional reliability allocation methods are introduced.Then the limitations of direct combination of comprehensive allocation method with the exponential transformed FMEA method are investigated.Subsequently,a cubic transformed function is established in order to overcome these limitations.Properties of the new transformed functions are discussed by considering the failure severity and the failure occurrence.Designers can choose appropriate transform amplitudes according to their requirements.Finally,a CNC lathe and a spindle system are used as an example to verify the new allocation method.Seven criteria are considered to compare the results of the new method with traditional methods.The allocation results indicate that the new method is more flexible than traditional methods.By employing the new cubic transformed function,the method covers a wider range of problems in CNC reliability allocation without losing the advantages of traditional methods.
