IEC 60976-2007 医用电气设备.医用电子加速器.功能特性

作者:标准资料网 时间:2024-05-12 17:40:52  浏览:8629   来源:标准资料网

【英文标准名称】:Medicalelectricalequipment-Medicalelectronaccelerators-Functionalperformancecharacteristics
【原文标准名称】:医用电气设备.医用电子加速器.功能特性
【标准号】:IEC60976-2007
【标准状态】:现行
【国别】:国际
【发布日期】:2007-10
【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】:角(几何学);撑架;定义;深度剂量;剂量;电气器具;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;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);立体定向;测试;测试条件
【英文主题词】:Angles(geometry);Brackets;Definitions;Depthdose;Dose;Electricappliances;Electricalengineering;Electricalmedicalequipment;Electromedicine;Electronaccelerators;Electronemission;Electrontubes;Electrotherapyequipment;Imageprocessing;Imaging;Inspection;Measurement;Measuringtechniques;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.NOTEAstatementofcompliancewiththisstandarddoesnotnecessarilyimplythatthesetestswillbeorhavebeenappliedasTYPETESTSorasindividualtests.
【中国标准分类号】:C37
【国际标准分类号】:11_040_50;13_280
【页数】:199P;A4
【正文语种】:英语