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【英文标准名称】:StandardPracticeforMarkingMedicalDevicesandOtherItemsforSafetyintheMagneticResonanceEnvironment
【原文标准名称】:磁共振环境下医疗装置和其他元件的安全标记的标准实施规程
【标准号】:ASTMF2503-2008
【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】:F04.15
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:
【英文主题词】:magnet;magnetic;medicaldevices;metals(forsurgicalimplants);MRI(magneticresonanceimaging);MRsafety;Magneticresonancetesting;Marking;Medicaldevices/equipment;Safety
【摘要】:MedicaldevicesandotheritemshavecausedseriousinjuriesanddeathforpatientsandotherindividualsintheMRenvironment.ThispracticeprovidesauniformsystemformarkingtoindicatetheMRconditionsthathavebeendeterminedtobeacceptableforamedicaldeviceorotheritem.ItprovidessimplevisualiconsandtermswhichareintendedtoreduceinjuriesandothermishapsthatoccurwhenitemsthatposehazardsintheMRenvironmentarebroughtintotheMRenvironment.pid="s00002">1.1Thispracticecoversthemarkingofmedicaldevicesandotheritemstoindicatetheirsafetyinthemagneticresonance(MR)environment.1.2Thepurposeofthispracticeisto(1)recommendthatitemsthatmaybebroughtintotheMRenvironmentbepermanentlymarkedtoindicatetheMRenvironmenttowhichaspecificitemmaysafelybeexposed,and(2)recommendinformationthatshouldbeincludedinthemarking.Itisrecognizedthatdirectmarkingontheitemisnotpracticalforimplantsandcertainothermedicaldevices.Wheredirectmarkingisnotpractical,thispracticerecommendsthatthemarkingbeincludedinthelabelingandonpatientinformationcards(see7.1).1.3Imageartifactisnotconsideredtobeasafetyissueandsoisnotaddressedinthispractice(seeX1.5).1.4ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C43;C37
【国际标准分类号】:11_040_01
【页数】:7P.;A4
【正文语种】:英语