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【英文标准名称】:Medicalproductscontainingviablehumancells-Applicationofriskmanagementandrequirementsforprocessingpractices
【原文标准名称】:含活性人体细胞的医疗产品.风险管理的应用和生产实践要求
【标准号】:ANSI/AAMI/ISO13022-2012
【标准状态】:现行
【国别】:美国
【发布日期】:2012
【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】:电池;细胞;定义(术语);文献工作;药物;搬运;人类生物学;人体;人用的药物;植入物(外科);医疗器械;医疗产品;风险分析;风险管理;规范(验收)
【英文主题词】:Cells;Cells(biology);Definitions;Documentation;Drugs;Handling;Humanbiology;Humanbody;Humanmedicine;Implants(surgical);Medicaldevices;Medicalproducts;Riskanalysis;Riskmanagement;Specification(approval)
【摘要】:Specifiesaproceduretoidentifythehazardsandhazardoussituationsandtomanagetheriskassociatedwithviablecellularcomponent(s)ofproductsregulatedasmedicinalproducts,biologics,medicaldevicesandactiveimplantablemedicaldevicesorcombinationsthereof.Coversviablehumanmaterialsofautologousaswellasallogeneichumanorigin.
【中国标准分类号】:C10
【国际标准分类号】:11_100_20
【页数】:
【正文语种】:英语


【英文标准名称】:Railwayapplications-Axleboxconditionmonitoring-Interfaceanddesignrequirements-Part1:Tracksideequipmentandrollingstockaxlebox
【原文标准名称】:铁路应用设施.轴箱情况监测.接口和设计要求.第1部分:轨道边设备和铁路车辆轴箱
【标准号】:BSEN15437-1-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2009-06-30
【实施或试行日期】:2009-06-30
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:轴承;定义;探测器;探测设备;高速火车;热轴箱;红外线;交替使用性;运行监控系统;操作安全性;过热;过热保护装置;性能要求;铁路设施;铁路交通;铁道车辆;铁路;安全性工程;安全性要求;规范(验收);规范;温度;温度测量;警告装置;警报系统;轮副轴承
【英文主题词】:Bearings;Definitions;Detector;Detectors;Highspeedtrains;Hotaxleboxes;Infra-red;Interoperability;Operationalmonitoringsystems;Operationalsafety;Overheating;Overheatingprotection;Performancerequirements;Railwayapplications;Railwaytraffic;Railwayvehicles;Railways;Safetyengineering;Safetyrequirements;Specification(approval);Specifications;Temperature;Temperaturemeasurement;Warningdevices;Warningsystem;Wheelsetbearings
【摘要】:ThispartofEN15437definestheminimumcharacteristicsfortheinterfacebetweenatracksideHotAxleboxDetector(HABD)andRollingStock(RST)thatcomplywiththeEuropeanDirectivesforInteroperabilitytoensurethattheminimumfunctionalrequirementoftheinterfaceisachieved.Theminimumrequirementsoftheinterfaceapplyto:a)RollingstockconformingtostandardEuropeanrailwaygauge,thatis1435mm;b)Rollingstockaxlesfittedwithoutboardbearings;NOTEThedesignofrollingstockaxlesfittedwithinboardbearingsshouldrespecttherequirementssetoutinNote2of5.2.c)Rollingstockwithamaximumoperationalspeedofuptoandincluding250km/h;NOTE1Thatisconventionalrailandclass2highspeedrailrollingstockasdefinedintherollingstockTSIs.NOTE2Interoperablerollingstockdesignedforspeedsabove250km/h(class1highspeedrollingstock)aremandatedtohaveon-boardequipmentforaxleboxconditionmonitoring.Therequirementsforon-boardequipmentaredescribedinpart2ofthisstandardwhichiscurrentlyunderdevelopment.NOTE3Interoperablerollingstockdesignedforspeedsabove250km/h(class1highspeedrollingstock)areoutsidethescopeofthisPartofthestandard.However,ifclass1highspeedtrainsarerequiredtobemonitoredbyHABDstheirtargetareashouldcomplywiththerequirementsspecifiedinthisstandard,exceptwherestatedotherwise.d)TracksideHABDsthatarerequiredtomonitorconventionalrailandclass2highspeedrailrollingstock.TherollingstockrequirementsoftheinterfacearedescribedinClause5andfortheHABDrequirementsoftheinterfacearedescribedinClause6.Thescopeofthispart(part1)ofthestandarddoesnotinclude:?HotWheel(HotDisc)Detectors(HWDs).However,HWDareofteninstalledincombinationwithtracksideHABDtoprovideadualmonitoringsystem.Thisstandarddoesnotpreventtheuseofsuchacombination;?howaHABDmeasuresthetemperatureandidentifiesaxleboxposition.Thisispartofanindividualequipmentdesignandnotpartofthefunctionalrequirementsofthisstandard;?operationalrequirementsforactingontheinformationreportedbytheHABDsystem;?maintenancerequirementsforHABDsystems.
【中国标准分类号】:S30
【国际标准分类号】:45_060_01
【页数】:28P.;A4
【正文语种】:英语