BS EN 80001-1-2011 集合医疗设备的IT网络的风险管理应用程序.作用,职责和行为

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【英文标准名称】:ApplicationofriskmanagementforIT-networksincorporatingmedicaldevices.Roles,responsibilitiesandactivities
【原文标准名称】:集合医疗设备的IT网络的风险管理应用程序.作用,职责和行为
【标准号】:BSEN80001-1-2011
【标准状态】:现行
【国别】:英国
【发布日期】:2011-04-30
【实施或试行日期】:2011-04-30
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:IEC/TC55
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:Analysismethods;Applications;Availability;Circuitnetworks;Communicationsystems;Communicationtechnology;Compatibility;Dataanalysis;Datacommunicationtraffic;Dataprotection;Datatransfer;Definitions;Dependabilitymanagement;Efficiency;Electricalengineering;Examination(qualityassurance);Hazards;Healthhazards;Informationexchange;Informationinterchange;Informationsuppliedbythemanufacturer;Informationtechnology;Instructions;Integrity;Interoperability;ITsecurity;ITsystems;Lifecycles;Maintenance;Management;Measure;Medicaldevices;Medicalelectronics;Medicalequipment;Medicalinformatics;Medicalproducts;Medicaltechnology;Organization;Planning;Process;Productsdocumentation;Reliability;Reliabilityanalysis;Reliabilitymanagement;Reliabilitytesting;Responsibility;Risk;Riskanalysis;Riskarea;Riskmanagement;Safety;Secrecy;Settlementofcompetence;Surveillance(approval);Systemology;Systems;Systemsanalysis;Testing
【摘要】:RecognizingthatMEDICALDEVICESareincorporatedintoIT-NETWORKStoachievedesirablebenefits(forexample,INTEROPERABILITY),thisinternationalstandarddefinestheroles,responsibilitiesandactivitiesthatarenecessaryforRISKMANAGEMENTofIT-NETWORKSincorporatingMEDICALDEVICEStoaddressSAFETY,EFFECTIVENESSandDATAANDSYSTEMSECURITY(theKEYPROPERTIES).ThisinternationalstandarddoesnotspecifyacceptableRISKlevels.NOTE1TheRISKMANAGEMENTactivitiesdescribedinthisstandardarederivedfromthoseinISO14971.TherelationshipbetweenISO14971andthisstandardisdescribedinAnnexA.ThisstandardappliesafteraMEDICALDEVICEhasbeenacquiredbyaRESPONSIBLEORGANIZATIONandisacandidateforincorporationintoanIT-NETWORK.NOTE2Thisstandarddoesnotcoverpre-marketRISKMANAGEMENT.ThisstandardappliesthroughoutthelifecycleofIT-NETWORKSincorporatingMEDICALDEVICES.NOTE3ThelifecyclemanagementactivitiesdescribedinthisstandardareverysimilartothoseofISO/IEC20000-2[10].TherelationshipbetweenISO/IEC20000-2andthisstandardisdescribedinAnnexD.ThisstandardapplieswherethereisnosingleMEDICALDEVICEmanufacturerassumingresponsibilityforaddressingtheKEYPROPERTIESoftheIT-NETWORKincorporatingaMEDICALDEVICE.NOTE4IfasinglemanufacturerspecifiesacompleteMEDICALDEVICEthatincludesanetwork,theinstallationorassemblyoftheMEDICALDEVICEaccordingtothemanufacturer’sACCOMPANYINGDOCUMENTSisnotsubjecttotheprovisionsofthisstandardregardlessofwhoinstallsorassemblestheMEDICALDEVICE.NOTE5IfasinglemanufacturerspecifiesacompleteMEDICALDEVICEthatincludesanetwork,additionstothatMEDICALDEVICEormodificationoftheconfigurationofthatMEDICALDEVICE,otherthanasspecifiedbythemanufacturer,issubjecttotheprovisionsofthisstandard.ThisstandardappliestoRESPONSIBLEORGANIZATIONS,MEDICALDEVICEmanufacturersandprovidersofotherinformationtechnologyforthepurposeofRISKMANAGEMENTofanITNETWORKincorporatingMEDICALDEVICESasspecifiedbytheRESPONSIBLEORGANIZATION.Thisstandarddoesnotapplytopersonaluseapplicationswherethepatient,OPERATORandRESPONSIBLEORGANIZATIONareoneandthesameperson.NOTE6IncaseswhereaMEDICALDEVICEisusedathomeunderthesupervisionorinstructionoftheprovider,thatproviderisdeemedtobetheRESPONSIBLEORGANIZATION.PersonalusewherethepatientacquiresandusesaMEDICALDEVICEwithoutthesupervisionorinstructionofaproviderisoutofscopeofthisstandard.Thisstandarddoesnotaddressregulatoryorlegalrequirements.
【中国标准分类号】:C30;C07
【国际标准分类号】:11_040_01;35_240_80
【页数】:46P.;A4
【正文语种】:英语