【英文标准名称】:StandardTestMethodforMeasurementofMagneticallyInducedTorqueonMedicalDevicesintheMagneticResonanceEnvironment
【原文标准名称】:磁共振环境中医疗设备中磁感应扭矩测量的标准试验方法
【标准号】:ASTMF2213-2006
【标准状态】:现行
【国别】:
【发布日期】:2006
【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】:环境;磁的;测量;惰性;共振;外科植入物;扭矩
【英文主题词】:force,magnetic;implant;metals(forsurgicalimplants);MRI(magneticresonanceimaging);MRsafety;torque,magnetic
【摘要】:Thistestmethodisoneofthoserequiredtodetermineifthepresenceofamedicaldevicemaycauseinjuryduringamagneticresonanceexaminationandinthemagneticresonanceenvironment.Othersafetyissueswhichshouldbeaddressedincludebutmaynotbelimitedtomagneticallyinducedforce(seeTestMethodF2052)andRFheating(seeTestMethodF2182).ThetermsandiconsinPracticeF2503shouldbeusedtomarkthedeviceforsafetyinthemagneticresonanceenvironment.Ifthemaximaltorqueislessthantheproductofthelongestdimensionofthemedicaldeviceanditsweight,thenthemagneticallyinduceddeflectiontorqueislessthantheworstcasetorqueonthedeviceduetogravity.Forthiscondition,itisassumedthatanyriskimposedbytheapplicationofthemagneticallyinducedtorqueisnogreaterthananyriskimposedbynormaldailyactivityintheEarthrsquo;gravitationalfield.Thisisconservative;itispossiblethatgreatertorqueswouldnotposeahazardtothepatient.ThistestmethodaloneisnotsufficientfordeterminingifanimplantissafeintheMRenvironment.Thesensitivityofthetorquemeasurementapparatusmustbegreaterthan1/10thex201C;gravitytorque,x201D;theproductofdeviceweightandthelargestlineardimension.Thetorqueconsideredhereisthemagneto-statictorqueduetotheinteractionoftheMRIstaticmagneticfieldwiththemagnetizationintheimplant.Thedynamictorqueduetointeractionofthestaticfieldwitheddycurrentsinducedinarotatingdeviceisnotaddressedinthistestmethod.Currentsinleadwiresmayinduceatorqueaswell.1.1Thistestmethodcoversthemeasurementofthemagneticallyinducedtorqueproducedbythestaticmagneticfieldinthemagneticresonanceenvironmentonmedicaldevicesandthecomparisonofthattorquetotheequivalenttorqueappliedbythegravitationalforcetotheimplant.1.2Thistestmethoddoesnotaddressotherpossiblesafetyissueswhichincludebutarenotlimitedtoissuesofmagneticallyinducedforceduetospatialgradientsinthestaticmagneticfield,RFheating,inducedheating,acousticnoise,interactionamongdevices,andthefunctionalityofthedeviceandtheMRsystem.1.3Thetorqueconsideredhereisthemagneto-statictorqueduetotheinteractionoftheMRIstaticmagneticfieldwiththemagnetizationintheimplant.Thedynamictorqueduetointeractionofthestaticfieldwitheddycurrentsinducedinarotatingdeviceisnotaddressedinthistestmethod.Currentsinleadwiresmayinduceatorqueaswell.1.4Thesensitivityofthetorquemeasurementapparatusmustbegreaterthan1/10the"gravitytorque,"theproductofthedevice''smaximumlineardimensionanditsweight.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C39
【国际标准分类号】:17_220_20
【页数】:7P.;A4
【正文语种】: