【英文标准名称】:StandardTestMethodforMeasurementofRadioFrequencyInducedHeatingNearPassiveImplantsDuringMagneticResonanceImaging
【原文标准名称】:磁共振成象时测量射频感应加热接近被动性植入物的标准试验方法
【标准号】:ASTMF2182-2002a
【标准状态】:现行
【国别】:
【发布日期】:2002
【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】:F04.15
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:
【英文主题词】:implant;MRI(magneticresonanceimaging);MRsafety;RF(RadioFrequency)heating
【摘要】:ThistestmethoddescribesatestprocedureforevaluatingtheRF-inducedtemperatureriseinMRIinthevicinityofanimplantedmedicaldevice.TheactualtemperatureriseinthepatientwilldependonavarietyoffactorsbeyondtheSARandtimeofRFapplication.TheconditionsandresultsofthetestingshouldbeincludedinthedevicelabelingsothattheattendingphysiciancanmakethedecisionofwhethertoallowthepatientwiththeimplanttoundergoanMRIprocedure.1.1ThistestmethodcoversmeasurementofRadioFrequency(RF)inducedheatingnearapassivemedicalimplantanditssurroundingsduringMagneticResonanceImaging(MRI).1.2ThistestmethodisoneofthoserequiredtodetermineifthepresenceofapassiveimplantmaycauseinjurytothepersonwiththeimplantduringanMRIprocedure.Othersafetyissuesthatshouldbeaddressedincludemagneticallyinduceddisplacementforceandtorque.1.3TheamountofRF-inducedtemperatureriseforagivenspecificabsorptionrate(SAR)willdependontheRFfrequency,whichisproportionaltothestaticmagneticfieldstrength.Becauseofpossibleadditionalheating,particularlywhendevicedimensionsexceedaquarterwavelength,conclusionsfrommeasurementsmadeatonefrequencymaynotapplytootherfrequencies.1.4Thistestmethodassumesthattestingisdoneondevicesthatwillbeentirelyinsidethebody.1.5Thistestmethodappliestowholebodymagneticresonanceequipment,asdefinedinsection2.2.103oftheIECStandard60601-2-33withawholebodyRFtransmitcoilasdefinedinsection2.2.100.TheRFcoilisassumedtohavequadratureexcitation.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:J04
【国际标准分类号】:11_040_40
【页数】:8P.;A4
【正文语种】: