BS EN 60976-2007 医疗电气设备.医疗电子加速器.功能的特性特征

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【英文标准名称】:Medicalelectricalequipment-Medicalelectronaccelerators-Functionalperformancecharacteristics
【原文标准名称】:医疗电气设备.医疗电子加速器.功能的特性特征
【标准号】:BSEN60976-2007
【标准状态】:现行
【国别】:英国
【发布日期】:2008-04-30
【实施或试行日期】:2004-03-30
【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】:角(几何学);撑架;定义;深度剂量;剂量;电器;电气工程;医用电气设备;电医学;电子加速器;电子发射;电子管;电疗设备;图像处理;成象;检验;测量;医疗设备;医学放射学;医学科学;医疗技术学;核医学;工作特性;幻象电路;光线疗法;质量;质量保证;辐射场;辐射学;放射器具(医学);放射疗法;规范(验收);立体定位的;测试;试验条件
【英文主题词】:Angles(geometry);Brackets;Definition;Definitions;Depthdose;Dose;Electricappliances;Electricalengineering;Electricalmedicalequipment;Electromedicine;Electronaccelerators;Electronemission;Electrontubes;Electrotherapyequipment;Imageprocessing;Imaging;Inspection;Measurement;Medicalequipment;Medicalradiology;Medicalsciences;Medicaltechnology;Nuclearmedicine;Performancecharacteristics;Phantoms;Phototherapy;Quality;Qualityassurance;Radiationfields;Radiology;Radiologyapparatus(medical);Radiotherapy;Specification(approval);Stereotactic;Testing;Testingconditions
【摘要】:ThisInternationalStandardappliestomedicalELECTRONACCELERATORSwhenused,fortherapypurposes,inhumanmedicalpractice.ThisstandardappliestomedicalELECTRONACCELERATORSwhichdeliveraRADIATIONBEAMofeitherX-RADIATIONorELECTRONRADIATIONwithNOMINALENERGIESintherange1MeVto50MeVatmaximumABSORBEDDOSERATESbetween0,001Gys–1and1Gys–1at1mfromtheRADIATIONSOURCEandatNORMALTREATMENTDISTANCESbetween50cmand200cmfromtheRADIATIONSOURCE.ThepresentstandarddescribesmeasurementsandtestprocedurestobeperformedbytheMANUFACTURERatthedesignandconstructionstageofamedicalELECTRONACCELERATORbutdoesnotspecifyACCEPTANCETESTStobeperformedafterinstallationatthepurchaser'ssite.Theaccompanyingreport,IEC60977,however,doessuggestthatmanyofthetestproceduresareappropriateforACCEPTANCETESTS.Themeasurementconditionsdescribedinthepresentstandarddifferfromthosepreviouslyinuse.ThisappliesparticularlytothePHANTOMpositionformeasurementsandthemeasurementofdistancesfromtheISOCENTRE.Thesenewconditionsshouldbesubstitutedforandnotbeaddedtopreviousmethods.Thisstandardspecifiestestproceduresforthedeterminationanddisclosureoffunctionalperformancecharacteristics,knowledgeofwhichisdeemednecessaryforproperapplicationanduseofamedicalELECTRONACCELERATORandwhicharetobedeclaredintheACCOMPANYINGDOCUMENTStogetherwiththegreatestdeviationorvariationtobeexpectedunderspecificconditionsinNORMALUSE.AformatforpresentationoffunctionalperformancevaluesisgiveninAnnexA.Itisrecognizedthatinaccuraciesinthetestmethodsmustbeallowedforwhenassessingperformance.However,itwasnotfelttobeadvisabletocombinetheerrorsintoanoverallperformancetolerancebuttokeepthemseparateintheexpectationthatmoreaccuratetestmethodswillbeevolved.Itisnotintendedthatthisstandardshouldinanywayinhibitthefuturedevelopmentofnewdesignsofequipmentwhichmayhaveoperatingmodesandparametersdifferentfromthosedescribedherein,providedthatsuchequipmentachievesequivalentlevelsofperformancefortheTREATMENTofPATIENTS.ExceptwhereotherwisestatedthisstandardassumesthatthemedicalELECTRONACCELERATORShaveanISOCENTRICGANTRY.Wheretheequipmentisnon-isocentric,thedescriptionofperformanceandtestmethodsmayneedtobesuitablyadapted.
【中国标准分类号】:C43
【国际标准分类号】:11_040_50;13_280
【页数】:102P.;A4
【正文语种】:英语