IEC 62083-2000 医用电气设备放射治疗计划系统的安全要求

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【英文标准名称】:Medicalelectricalequipment-Requirementsforthesafetyofradiotherapytreatmentplanningsystems
【原文标准名称】:医用电气设备放射治疗计划系统的安全要求
【标准号】:IEC62083-2000
【标准状态】:作废
【国别】:国际
【发布日期】:2000-11
【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/SC62C
【标准类型】:()
【标准水平】:()
【中文主题词】:规范;医学信息;危险防护;医学科学;规范(验收);数据安全;安全;辐照器;数据处理(软件);医疗技术学;数据处理;处理;医疗设备;安全要求;电气器具;短期治疗;个人数据;光疗法;规划法;放射疗法;电医学;医学放射学;数据保护;定义;操作安全;病患者保护;病人;吸收剂量
【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】:C43
【国际标准分类号】:11_040_60
【页数】:59P;A4
【正文语种】:英语