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IEC/TR 62278-3-2010 铁路应用设施.可靠性、可用性、可维修性和安全性(RAMS)的规范和验证.第3部分:全部车辆RAM用EN50126-1标准应用指南

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【英文标准名称】:Railwayapplications-Specificationanddemonstrationofreliability,availability,maintainabilityandsafety(RAMS)-Part3:GuidetotheapplicationofIEC62278forrollingstockRAM
【原文标准名称】:铁路应用设施.可靠性、可用性、可维修性和安全性(RAMS)的规范和验证.第3部分:全部车辆RAM用EN50126-1标准应用指南
【标准号】:IEC/TR62278-3-2010
【标准状态】:现行
【国别】:国际
【发布日期】:2010-04
【实施或试行日期】:
【发布单位】:国际电工委员会(IX-IEC)
【起草单位】:IEC/TC9
【标准类型】:()
【标准水平】:()
【中文主题词】:有效性;定义;电气工程;维修性;维修;管理;网控制点;工作性能;组织;过程;质量管理;轨道;铁路运输;铁路设施;铁路设备;铁路运营;铁路;相关程序的可靠性;可靠度;安全;规范;验证
【英文主题词】:Availability;Definitions;Electricalengineering;Maintainability;Maintenance;Management;Net-controlstations;Operatability;Organization;Process;Qualitymanagement;Railtracks;Railtransport;Railwayapplications;Railwayinstallations;Railwayoperation;Railways;Reabilityrelatedprogram;Reliability;Safety;Specification;Verification
【摘要】:ThispartofIEC62278providesguidanceonapplyingtheRAMrequirementsinIEC62278torollingstockandfordealingwithRAMactivitiesduringthesystemlifecyclephasesfrominvitationtotendertodemonstrationinoperationonly.AllreferencestoIEC62278concernthe2002issue.Theguideisaimedatthecustomers/operatorsandmainsuppliersofrollingstock.Themainpurposeoftheguideisto:?enableacustomer/operatorofrollingstock:–tospecifytheRAMrequirementsaddressingthetypeofoperationintermsoftheendcustomerneeds,consideringserviceavailabilityandeconomicconsiderations;–toevaluatedifferenttenders,intermsofRAMrequirements,onacommonbasiswiththeaidofspecificRAMdocuments;–togainassurance,duringdesign/developmentphase,thattherollingstockbeingofferedislikelytosatisfytheRAMcontractualrequirementsbyexaminingstepbystepdetailedandspecificRAMdocumentsasanoutputoftheRAMactivitiesperformedduringthedevelopmentphase;–tovalidatethattherollingstock,asdelivered,satisfiesthespecifiedRAMrequirements;?toenablethemainsupplierofrollingstock;–tounderstandthecustomers/operatorsRAMrequirements;–toprovidesubstantiveinformation/visibilityinatendertoshowthattheproductofferedislikelytosatisfytheRAMrequirementsbyperformingpreliminaryRAManalysis;–toprovidesubstantiveinformationduringdesign/developmentphasetoshowthattheproductofferedislikelytosatisfytheRAMrequirementsbyperformingdetailedRAManalysis;–todemonstratethattheproductdeliveredsatisfiestheRAMrequirements.RegardingLCC,thisapplicationguideisrestrictedtoprovidingonlythekeyRAMparametersnecessarytobeincorporatedintoanLCCmodel.
【中国标准分类号】:S50
【国际标准分类号】:29_280;45_020
【页数】:70P.;A4
【正文语种】:英语


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【英文标准名称】:Biologicalevaluationofmedicaldevices-Part1:Evaluationandtestingwithinariskmanagementsystem
【原文标准名称】:医疗器械的生物学评价.第1部分:风险管理系统内的评价与测试
【标准号】:ANSI/AAMI/ISO10993-1-2009
【标准状态】:现行
【国别】:美国
【发布日期】:2009
【实施或试行日期】:
【发布单位】:美国国家标准学会(US-ANSI)
【起草单位】:ANSI
【标准类型】:()
【标准水平】:()
【中文主题词】:生物测定;生物适应性;生物的;生物分析和试验;生物试验;类别;分类;兼容性;定义;评定;精密机械;适用性;人体;外科植入物;医疗器械;医疗设备;医疗产品;医学科学;医疗技术学;原则;风险管理;选择;外科设备;试验;使用
【英文主题词】:Bioassay;Biocompatibility;Biological;Biologicalanalysisandtesting;Biologicaltests;Categories;Classification;Compatibility;Definitions;Evaluations;Finemechanics;Fitnessforpurpose;Humanbody;Implants(surgical);Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Principles;Riskmanagement;Selection;Surgicalequipment;Testing;Use
【摘要】:AAMI/ISO10993-1describesthegeneralprinciplesgoverningthebiologicalevaluationofmedicaldeviceswithinariskmanagementframework;thegeneralcategorizationofdevicesbasedonthenatureanddurationoftheircontactwiththebody;theevaluationofexistingrelevantdatafromallsources;theidentificationofgapsintheavailabledatasetonthebasisofariskanalysis;theidentificationofadditionaldatasetsnecessarytoanalyzethebiologicalsafetyofthemedicaldevice;andtheassessmentofthebiologicalsafetyofthemedicaldevice.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:
【正文语种】:英语