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【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】:ERRATAtoASMEB47.1-2007GageBlanks
【原文标准名称】:ASMEB47.1-2007标准勘误.量规半成品
【标准号】:ASMEB47.1ERTA-2010
【标准状态】:现行
【国别】:美国
【发布日期】:2010-01
【实施或试行日期】:
【发布单位】:美国机械工程师协会(US-ASME)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:
【摘要】:
【中国标准分类号】:J42
【国际标准分类号】:
【页数】:2P.;A4
【正文语种】:英语