ISO/TS 10974-2012 患者带有有源植入性医疗器械用核磁共振成像的安全性评定
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【英文标准名称】:Assessmentofthesafetyofmagneticresonanceimagingforpatientswithanactiveimplantablemedicaldevice
【原文标准名称】:患者带有有源植入性医疗器械用核磁共振成像的安全性评定
【标准号】:ISO/TS10974-2012
【标准状态】:现行
【国别】:国际
【发布日期】:2012-05
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC150
【标准类型】:()
【标准水平】:()
【中文主题词】:计算机断层摄影;定义(术语);诊断设备;电击;医用电气设备;电气安全性;电磁兼容性;电医学;电磁兼容性(EMC);危害;高频;成象;植入物(外科);指示;中断;磁场;磁共振设备;故障;测量;测量技术;医疗设备;医学科学;医疗技术学;病患者保护;病人;危险防护;防电击;脉冲能量;辐射;辐射防护;安全性;安全性要求;监督(认可);试验
【英文主题词】:Computedtomography;Definitions;Diagnosticequipment;Electricshock;Electricalmedicalequipment;Electricalsafety;Electromagneticcompatibility;Electromedicine;EMC;Hazards;Highfrequencies;Imaging;Implants(surgical);Indications;Interruptions;Magneticfields;Magneticresonanceequipment;Malfunction;Measurement;Measuringtechniques;Medicalequipment;Medicalsciences;Medicaltechnology;Patientprotection;Patients;Protectionagainstdanger;Protectionagainstelectricshocks;Pulseenergy;Radiation;Radiationprotection;Safety;Safetyrequirements;Surveillance(approval);Testing
【摘要】:
【中国标准分类号】:C43
【国际标准分类号】:11_040_40
【页数】:200P;A4
【正文语种】:英语
【英文标准名称】:StandardPracticeforEstimationofMeasurementUncertaintyforDatafromRegression-basedMethods
【原文标准名称】:基于回归方法从预测不确定度获得数据的标准指南
【标准号】:ASTMD7366-2008
【标准状态】:现行
【国别】:美国
【发布日期】:2008
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:D19.02
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:
【英文主题词】:measurementuncertainty;regression-basedmethods;calibration;predictioninterval;confidencelevel
【摘要】:Appropriateapplicationofthispracticeshouldresultinanestimateofthetest-methodx2019;suncertainty(atanyconcentrationwithintheworkingrange),whichcanbecomparedwithdata-qualityobjectivestoseeiftheuncertaintyisacceptable.Withdatasetsthatcomparerecoveredconcentrationwithtrueconcentration,theresultingregressionplotallowsthecorrectionoftherecoverydatatotruevalues.Reportingofsuchcorrectionsisatthediscretionoftheuser.Thispracticeshouldbeusedtoestimatethemeasurementuncertaintyforanyapplicationofatestmethodwheremeasurementuncertaintyisimportanttodatause.1.1ThispracticeestablishesastandardforcomputingthemeasurementuncertaintyforapplicabletestmethodsinCommitteeD19onWater.Thepracticedoesnotprovideasingle-pointestimatefortheentireworkingrange,butratherrelatestheuncertaintytoconcentration.Thestatisticaltechniqueofregressionisemployedduringdataanalysis.1.2Applicabletestmethodsarethosewhoseresultscomefromregression-basedmethodsandwhosedataareintra-laboratory(notinter-laboratorydata,suchasresultfromround-robinstudies).Foreachanalysisconductedusingsuchamethod,itisassumedthatafixed,reproducibleamountofsampleisintroduced.1.3Calculationofthemeasurementuncertaintyinvolvestheanalysisofdatacollectedtohelpcharacterizetheanalyticalmethodoveranappropriateconcentrationrange.Examplesourcesofdatainclude:1)calibrationstudies(whichmayormaynotbeconductedinpuresolvent),2)recoverystudies(whichtypicallyareconductedinmatrixandincludeallsample-preparationsteps),and3)collectionsofdataobtainedaspartofthemethodx2019;songoingQualityControlprogram.Useofmultipleinstruments,multipleoperators,orboth,andfield-samplingprotocolsmayormaynotbereflectedinthedata.1.4Inanydesignedstudywhosedataaretobeusedtocalculatemethoduncertainty,theusershouldthinkcarefullyaboutwhatthestudyistryingtoaccomplishandmuchvariationshouldbeincorporatedintothestudy.Generalguidanceondesigningstudies(forexample,calibration,recovery)isgiveninAppendixA.Detailedguidelinesonsourcesofvariationareoutsidethescopeofthispractice,butgeneralpointstoconsiderareincludedinAppendixB,whichisnotintendedtobeexhaustive.Withanystudy,theusermustthinkcarefullyaboutthefactorsinvolvedwithconductingtheanalysis,andmustrealizethatthecomputedmeasurementuncertaintywillreflectthequalityoftheinputdata.1.5Associatedwiththemeasurementuncertaintyisauser-chosenlevelofstatisticalconfidence.1.6Atanyconcentrationintheworkingrange,themeasurementuncertaintyisplus-or-minusthehalf-widthofthepredictionintervalassociatedwiththeregressionline.1.7Itisassumedthattheuserhasaccesstoastatisticalsoftwarepackageforperformingregression.Astatisticianshouldbeconsultedifassistanceisneededinselectingsuchaprogram.1.8Astatisticianalsoshouldbeconsultedifdatatransformationsarebeingconsidered.1.9Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:Z16
【国际标准分类号】:13_060_45
【页数】:7P.;A4
【正文语种】:英语
【英文标准名称】:Opensystemsinterconnection;protocolcombinationstoprovidethenetworkservice;generalprinciples;identicalwithISO/IEC8880-1:1990
【原文标准名称】:开放系统互连.提供网络服务的协议组合.一般原理
【标准号】:DIN66342-1-1992
【标准状态】:作废
【国别】:德国
【发布日期】:1992-12
【实施或试行日期】:
【发布单位】:德国标准化学会(DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:组合;数据传输方法;多语种的;网络服务;数据网络;数据通信;开式系统;信息交流;定义;数据传送;信息处理;网络层;通信系统;协议;传播技术;网络互连;开式系统互连;通信规程
【英文主题词】:
【摘要】:documentdescribesthegeneralrulesfortheprovisionoftheOSInetworkservicebymeansofdifferentprotocolcombinations.
【中国标准分类号】:L79
【国际标准分类号】:35_100_30
【页数】:12P;A4
【正文语种】:德语
