【英文标准名称】:Medicaldevicesoftware-Softwarelifecycleprocesses
【原文标准名称】:医疗器械用软件.软件寿命过程
【标准号】:IEC62304-2006
【标准状态】:现行
【国别】:国际
【发布日期】:2006-05
【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/SC62A
【标准类型】:()
【标准水平】:()
【中文主题词】:计算机应用;计算机软件;计算机;数据处理;定义;电气工程;电气设备;电气安全;电子设备;电子系统;信息处理;检验;寿命;医用信息;医疗产品;医学科学;医疗技术学;过程;过程控制;工艺管理;处理系统;程序控制系统;程序设计;程序设计技术;可靠度;安全;安全装置;安全工程;安全措施;安全要求;安全研究;安全系统;软件;规范(验收);监督(认可);试验
【英文主题词】:Computerapplications;Computersoftware;Computers;Dataprocessing;Definitions;Electricalequipment;Electricalsafety;Electronicequipment;Electronicsystems;Informationprocessing;Inspection;Lifecycles;Medicaldevices;Medicalinformatics;Medicalproducts;Medicalsciences;Medicaltechnology;Process;Processcontrol;Processmanagement;Programsystem;Programmedcontrolsystems;Programming;Programmingtechniques;Reliability;Safety;Safetydevices;Safetyengineering;Safetymeasures;Safetyrequirements;Safetystudies;Safetysystems;Software;Specification(approval);Surveillance(approval);Testing
【摘要】:1.1*PurposeThisstandarddefinesthelifecyclerequirementsforMEDICALDEVICESOFTWARE.ThesetofPROCESSES,ACTIVITIES,andTASKSdescribedinthisstandardestablishesacommonframeworkforMEDICALDEVICESOFTWARElifecyclePROCESSES.1.2*FieldofapplicationThisstandardappliestothedevelopmentandmaintenanceofMEDICALDEVICESOFTWARE.ThisstandardappliestothedevelopmentandmaintenanceofMEDICALDEVICESOFTWAREwhensoftwareisitselfaMEDICALDEVICEorwhensoftwareisanembeddedorintegralpartofthefinalMEDICALDEVICE.ThisstandarddoesnotcovervalidationandfinalreleaseoftheMEDICALDEVICE,evenwhentheMEDICALDEVICEconsistsentirelyofsoftware.1.3RelationshiptootherstandardsThisMEDICALDEVICESOFTWARElifecyclestandardistobeusedtogetherwithotherappropriatestandardswhendevelopingaMEDICALDEVICE.AnnexCshowstherelationshipbetweenthisstandardandotherrelevantstandards.1.4ComplianceCompliancewiththisstandardisdefinedasimplementingallofthePROCESSES,ACTIVITIES,andTASKSidentifiedinthisstandardinaccordancewiththesoftwaresafetyclass.NOTEThesoftwaresafetyclassesassignedtoeachrequirementareidentifiedinthenormativetextfollowingtherequirement.ComplianceisdeterminedbyinspectionofalldocumentationrequiredbythisstandardincludingtheRISKMANAGEMENTFILE,andassessmentofthePROCESSES,ACTIVITIESandTASKSrequiredforthesoftwaresafetyclass.SeeAnnexD.NOTE1Thisassessmentcouldbecarriedoutbyinternalorexternalaudit.NOTE2AlthoughthespecifiedPROCESSES,ACTIVITIES,andTASKSareperformed,flexibilityexistsinthemethodsofimplementingthesePROCESSESandperformingtheseACTIVITIESandTASKS.NOTE3Whereanyrequirementscontain“asappropriate”andwerenotperformed,documentationforthejustificationisnecessaryforthisassessment.NOTE4Theterm“conformance”isusedinISO/IEC12207wheretheterm“compliance”isusedinthisstandard.
【中国标准分类号】:C07
【国际标准分类号】:35_240_80
【页数】:155P.;A4
【正文语种】:英语


【英文标准名称】:Smokedetectorsforfirealarmsignalingsystems
【原文标准名称】:火灾报警信号系统用烟雾探测器
【标准号】:UL268-2006
【标准状态】:作废
【国别】:美国
【发布日期】:2006-09-08
【实施或试行日期】:
【发布单位】:美国保险商实验所(US-UL)
【起草单位】:UL
【标准类型】:()
【标准水平】:()
【中文主题词】:组件;控制图;定义;电力系统;电气元件;电气设备;电驱动装置;供能系统(建筑物);火灾警报;消防队;火灾探测器;防火;防火安全;检验;作标记;性能;性能试验;安全装置;信号装置;发信号;烟雾检测器;规范(验收);试验;警告装置
【英文主题词】:Components;Controlcharts;Definitions;Electricpowersystems;Electricalcomponents;Electricalequipment;Electrically-operateddevices;Energysupplysystems(buildings);Firealarms;Firebrigade;Firedetectors;Fireprotection;Firesafety;Inspection;Marking;Performance;Performancetests;Safetydevices;Signaldevices;Signalling;Smokedetectors;Specification(approval);Testing;Warningdevices
【摘要】:TheserequirementscoversmokedetectorsintendedtobeemployedinindoorlocationsinaccordancewiththeNationalFireAlarmCode,NFPA72.Theserequirementsalsocovermechanicalguardsusedtoprovidephysicalprotectiontoinstalledsmokedetectors.Asmokedetector,ascoveredbytheserequirements,consistsofanassemblyofelectricalcomponentscoupledwithasensingmeansinsideofachamber,orbyseparatecomponents,todetectsmoke.Thedetectorincludesprovisionfortheconnectiontoasourceofpower,signaling,andremotecontrolcircuits.Aheatdetector,oraudiblesignalingappliance,orboth,arenotprohibitedfrombeingincorporatedaspartofthesmokedetectorassembly.Theserequirementscoverthefollowingtypesofdetectors:a)Detectorsintendedforopenareaprotectionandforconnectiontoacompatiblepowersupplyorcontrolunitforoperationaspartofafirealarmsystem.b)Detectorsintendedsolelyforcontrolofreleasingdevicessuchaselectromagneticdoorholders,firedampersorsmokedampers.c)Detectorsintendedforboththeapplicationsdescribedin(a)and(b)above.Thisstandarddoesnotcoverthefollowing:a)ControlunitstowhichthedetectorsareintendedtobeconnectedthatarecoveredbytheStandardforControlUnitsforFire-ProtectiveSignalingSystems,UL864.b)Self-containedsingleandmultiplestationsmokedetectors,notintendedforconnectiontoasystemcontrolunit,thatarecoveredbytheStandardforSingleandMultipleStationSmokeAlarms,UL217.c)Aheatdetectorincorporatedasapartofasmokedetectorassembly,andcoveredbytheStandardforHeatDetectorsforFireProtectiveSignalingSystems,UL521;exceptfortherequirementsoftheFireTest(HeatDetector).d)FiretestsforsmokedetectorsintegralwithcombinationdoorclosersandholdersthatarecoveredbytheStandardforDoorClosers-Holders,WithorWithoutIntegralSmokeDetectors,UL228.e)Commercial-residentialdetectorsnotintendedforconnectiontoasystemcontrolunitthatarecoveredbytheStandardforSmokeDetectorMonitorsandAccessoriesforIndividualLivingUnitsofMultifamilyResidencesandHotel/MotelRooms,UL1730.Theserequirementsalsocoverallremoteaccessoriesthatareintendedtobeconnectedtoasmokedetector.Aproductthatcontainsfeatures,characteristics,components,materials,orsystemsnewordifferentfromthosecoveredbytherequirementsinthisstandard,andthatinvolvesariskoffire,electricshock,orinjurytopersonsshallbeevaluatedusingtheappropriateadditionalcomponentandend-productrequirementsasdeterminedessentialtomaintaintheintendedlevelofsafetyasoriginallyanticipatedbytheintentofthisstandard.Aproductwhosefeatures,characteristics,components,materials,orsystemsconflictwithspecificprovisionsofthisstandardcannotbejudgedtocomplywiththisstandard.Whereidentifiedasappropriate,revisionofrequirementsshallbeproposedandadoptedinconformancewiththemethodsemployedfordevelopment,revision,andimplementationofthisstandard.
【中国标准分类号】:C81
【国际标准分类号】:13_220_20
【页数】:
【正文语种】:英语