BS EN 62083-2001 医用电气设备.放射处理计划系统安全性要求
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【英文标准名称】:Medicalelectricalequipment.Requirementsforthesafetyofradiotherapytreatmentplanningsystems
【原文标准名称】:医用电气设备.放射处理计划系统安全性要求
【标准号】:BSEN62083-2001
【标准状态】:作废
【国别】:英国
【发布日期】:2001-05-15
【实施或试行日期】:2001-05-15
【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】:放射疗法;数学模型;装配;医学放射学;安全措施;数据传送;计划;计算机软件;设计;电子设备及元件;医用电气设备;设备安全;电气设备;医疗设备
【英文主题词】:Absorbeddoses;Brachytherapy;Datahandling(software);Dataprocessing;Dataprotection;Datasecurity;Definitions;Electricappliances;Electromedicine;Irradiationapparatus;Medicalequipment;Medicalinformatics;Medicalradiology;Medicalsciences;Medicaltechnology;Operationalsafety;Patientprotection;Patients;Personaldata;Phototherapy;Planningmethod;Protectionagainstdanger;Radiotherapy;Safety;Safetyrequirements;Specification;Specification(approval);Treatment
【摘要】:ThisInternationalStandardappliestothedesign,manufactureandsomeinstallationaspectsofanRTPS-foruseinRADIOTHERAPYTREATMENTPLANNINGinhumanmedicalpractice;-thatimportsdataeitherthroughinputbytheOPERATORordirectfromotherdevices;-thatoutputsdataeitherinprintedformforreviewordirecttootherdevices;-andwhichisintendedtobe·forNORMALUSE,undertheauthorityofappropriatelylicensedorQUALIFIEDPERSONS,byOPERATORShavingtherequiredskillsandtraining;·maintainedinaccordancewiththerecommendationsgivenintheINSTRUCTIONSFORUSE,and·usedwithintheenvironmentalandelectricalsupplyconditionsSPECIFIEDinthetechnicaldescription.AnRTPSdevelopedbyaUSERforitsownuseexclusivelyisnotwithinthescopeofthisstandard,butitishighlyrecommendedthattheprinciplesofthisstandardbeappliedinitscreationanduse.IfsuchanRTPSisprovidedtoanotherUSERinwhichthedevelopersdonotdirectlycontrolitsuse,andisrepresentedasbeingsuitableforuse,thenthedevelopersassumetheroleofMANUFACTURER,andthisstandardapplies.AnRTPSisprincipallyasoftwareapplication,andtheobjectofthisstandardistoestablishtherequirementsforfeatures,associateddocumentation,andtestingofthesoftware.RequirementsforSAFETYofhardwarearenotincludedinthisstandard,astheyvarywiththenatureofthehardware.See3.1andannexAforhardwarerequirements.
【中国标准分类号】:C39
【国际标准分类号】:11_040_50
【页数】:34P.;A4
【正文语种】:英语
【原文标准名称】:医用电气设备.放射处理计划系统安全性要求
【标准号】:BSEN62083-2001
【标准状态】:作废
【国别】:英国
【发布日期】:2001-05-15
【实施或试行日期】:2001-05-15
【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】:放射疗法;数学模型;装配;医学放射学;安全措施;数据传送;计划;计算机软件;设计;电子设备及元件;医用电气设备;设备安全;电气设备;医疗设备
【英文主题词】:Absorbeddoses;Brachytherapy;Datahandling(software);Dataprocessing;Dataprotection;Datasecurity;Definitions;Electricappliances;Electromedicine;Irradiationapparatus;Medicalequipment;Medicalinformatics;Medicalradiology;Medicalsciences;Medicaltechnology;Operationalsafety;Patientprotection;Patients;Personaldata;Phototherapy;Planningmethod;Protectionagainstdanger;Radiotherapy;Safety;Safetyrequirements;Specification;Specification(approval);Treatment
【摘要】:ThisInternationalStandardappliestothedesign,manufactureandsomeinstallationaspectsofanRTPS-foruseinRADIOTHERAPYTREATMENTPLANNINGinhumanmedicalpractice;-thatimportsdataeitherthroughinputbytheOPERATORordirectfromotherdevices;-thatoutputsdataeitherinprintedformforreviewordirecttootherdevices;-andwhichisintendedtobe·forNORMALUSE,undertheauthorityofappropriatelylicensedorQUALIFIEDPERSONS,byOPERATORShavingtherequiredskillsandtraining;·maintainedinaccordancewiththerecommendationsgivenintheINSTRUCTIONSFORUSE,and·usedwithintheenvironmentalandelectricalsupplyconditionsSPECIFIEDinthetechnicaldescription.AnRTPSdevelopedbyaUSERforitsownuseexclusivelyisnotwithinthescopeofthisstandard,butitishighlyrecommendedthattheprinciplesofthisstandardbeappliedinitscreationanduse.IfsuchanRTPSisprovidedtoanotherUSERinwhichthedevelopersdonotdirectlycontrolitsuse,andisrepresentedasbeingsuitableforuse,thenthedevelopersassumetheroleofMANUFACTURER,andthisstandardapplies.AnRTPSisprincipallyasoftwareapplication,andtheobjectofthisstandardistoestablishtherequirementsforfeatures,associateddocumentation,andtestingofthesoftware.RequirementsforSAFETYofhardwarearenotincludedinthisstandard,astheyvarywiththenatureofthehardware.See3.1andannexAforhardwarerequirements.
【中国标准分类号】:C39
【国际标准分类号】:11_040_50
【页数】:34P.;A4
【正文语种】:英语
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