ASTM F2052-2006e1 测量磁共振环境中医疗设备磁感应位移力的标准试验方法

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【英文标准名称】:StandardTestMethodforMeasurementofMagneticallyInducedDisplacementForceonMedicalDevicesintheMagneticResonanceEnvironment
【原文标准名称】:测量磁共振环境中医疗设备磁感应位移力的标准试验方法
【标准号】:ASTMF2052-2006e1
【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】:力;磁的;磁学;测量;外科植入物;试验方法
【英文主题词】:medicaldevice;metals(forsurgicalimplantsandmedicaldevices);MRI(magneticresonanceimaging);MRsafety
【摘要】:ThistestmethodisoneofthoserequiredtodetermineifthepresenceofamedicaldevicemaycauseinjurytoindividualsduringanMRexaminationandintheMRenvironment.Othersafetyissueswhichshouldbeaddressedincludebutmaynotbelimitedtomagneticallyinducedtorque(seeTestMethodF2213)andRFheating(seeTestMethodF2182).ThetermsandiconsinPracticeF2503shouldbeusedtomarkthedeviceforsafetyinthemagneticresonanceenvironment.Ifthedevicedeflectslessthan45x00B0;,thenthemagneticallyinduceddeflectionforceislessthantheforceonthedeviceduetogravity(itsweight).Forthiscondition,itisassumedthatanyriskimposedbytheapplicationofthemagneticallyinducedforceisnogreaterthananyriskimposedbynormaldailyactivityintheEarthrsquo;gravitationalfield.Adeflectionoflessthan45x00B0;atthelocationofthemaximumstaticmagneticfieldgradientinoneMRsystemdoesnotprecludeadeflectionexceeding45x00B0;inasystemwithahigherfieldstrengthorlargerstaticfieldgradients.ThistestmethodaloneisnotsufficientfordeterminingifadeviceissafeintheMRenvironment.1.1Thistestmethodcoversthemeasurementofthemagneticallyinduceddisplacementforceproducedbystaticmagneticfieldgradientsonmedicaldevicesandthecomparisonofthatforcetotheweightofthemedicaldevice.1.2Thistestmethoddoesnotaddressotherpossiblesafetyissueswhichincludebutarenotlimitedtoissuesofmagneticallyinducedtorque,RFheating,inducedheating,acousticnoise,interactionamongdevices,andthefunctionalityofthedeviceandtheMRsystem.1.3Thistestmethodisintendedfordevicesthatcanbesuspendedfromastring.Deviceswhichcannotbesuspendedfromastringarenotcoveredbythistestmethod.Theweightofthestringfromwhichthedeviceissuspendedduringthetestmustbelessthan1%oftheweightofthetesteddevice.1.4Thistestmethodshallbecarriedoutinasysteminwhichthedirectionofthemagneticallyinduceddeflectionforceishorizontal.1.5ThevaluesstatedinSIunitsaretoberegardedasstandard.Valuesinparenthesesareforinformationonly.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatoryrequirementspriortouse.
【中国标准分类号】:C43
【国际标准分类号】:11_040_40
【页数】:6P.;A4
【正文语种】: