【英文标准名称】:Medicaldevicesoftware-Softwarelife-cycleprocesses
【原文标准名称】:医疗器械软件.软件使用周期过程
【标准号】:BSEN62304-2006
【标准状态】:现行
【国别】:英国
【发布日期】:2006-11-30
【实施或试行日期】:2006-11-30
【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】:计算机应用;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;生命周期;医疗信息学;医疗产品;医学科学;医疗技术学;过程;过程控制;过程管理;程序系统;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;Definition;Definitions;Electricalengineering;Electricalequipment;Electricalsafety;Electronicequipment;Electronicsystems;Informationprocessing;Inspection;Lifecycles;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】:ThisstandarddefinesthelifecyclerequirementsforMEDICALDEVICESOFTWARE.ThesetofPROCESSES,ACTIVITIES,andTASKSdescribedinthisstandardestablishesacommonframeworkforMEDICALDEVICESOFTWARElifecyclePROCESSES.ThisstandardappliestothedevelopmentandmaintenanceofMEDICALDEVICESOFTWARE.ThisstandardappliestothedevelopmentandmaintenanceofMEDICALDEVICESOFTWAREwhensoftwareisitselfaMEDICALDEVICEorwhensoftwareisanembeddedorintegralpartofthefinalMEDICALDEVICE.ThisstandarddoesnotcovervalidationandfinalreleaseoftheMEDICALDEVICE,evenwhentheMEDICALDEVICEconsistsentirelyofsoftware.ThisMEDICALDEVICESOFTWARElifecyclestandardistobeusedtogetherwithotherappropriatestandardswhendevelopingaMEDICALDEVICE. HAnnexCshowstherelationshipbetweenthisstandardandotherrelevantstandards.CompliancewiththisstandardisdefinedasimplementingallofthePROCESSES,ACTIVITIES,andTASKSidentifiedinthisstandardinaccordancewiththesoftwaresafetyclass.NOTEThesoftwaresafetyclassesassignedtoeachrequirementareidentifiedinthenormativetextfollowingtherequirement.ComplianceisdeterminedbyinspectionofalldocumentationrequiredbythisstandardincludingtheRISKMANAGEMENTFILE,andassessmentofthePROCESSES,ACTIVITIESandTASKSrequiredforthesoftwaresafetyclass.See HAnnexD.
【中国标准分类号】:C30
【国际标准分类号】:11_040_01;35_080;35_240_80
【页数】:80P.;A4
【正文语种】:英语