Designation:F2503−13StandardPracticeforMarkingMedicalDevicesandOtherItemsforSafetyintheMagneticResonanceEnvironment1ThisstandardisissuedunderthefixeddesignationF2503;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisinternationalstandardappliestothepracticeofmarkingofitemsthatmightbeusedinthemagneticresonance(MR)environment.1.2ThepurposeofthispracticeistomarkitemsthatmightbebroughtintotheMRenvironmentandtorecommendinformationthatshouldbeincludedinthemarking.1.3Thestandardspecifiesthepermanentmarkingofitems,whichareusedinanMRenvironment,bymeansoftermsandicons.1.4MRimageartifactsarenotconsideredtobeaperfor-manceissueandsoarenotaddressedinthisinternationalstandardpractice(seeX1.5).1.5ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1Thefollowingreferenceddocumentsareindispensablefortheapplicationofthisdocument.Fordatedreferences,onlytheeditioncitedapplies.Forundatedreferences,thelatesteditionofthereferenceddocument(includinganyamend-ments)applies.2.2ASTMStandards:2F2052TestMethodforMeasurementofMagneticallyIn-ducedDisplacementForceonMedicalDevicesintheMagneticResonanceEnvironmentF2119TestMethodforEvaluationofMRImageArtifactsfromPassiveImplantsF2182TestMethodforMeasurementofRadioFrequencyInducedHeatingOnorNearPassiveImplantsDuringMagneticResonanceImagingF2213TestMethodforMeasurementofMagneticallyIn-ducedTorqueonMedicalDevicesintheMagneticReso-nanceEnvironment2.3OtherStandards:IEC60601-2-33MedicalElectricalEquipment—Part2-33:ParticularReq...
