Designation:D4774−11(Reapproved2017)StandardSpecificationforUserAppliedDrugLabelsinAnesthesiology1ThisstandardisissuedunderthefixeddesignationD4774;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoversthesize,color,pattern,andtypeusedonlabelsappliedtounlabeledsyringesfilledbytheusersortheiragentstoidentifythedrugcontent.Thisspeci-ficationisnotintendedtocoverlabelsappliedbythedrugmanufacturer.1.2ThevaluesstatedinSIunitsaretoberegardedastherecommendedvalues.Theuseofinch-poundsystemvalues,notbeingexactequivalents,mayresultinnonconformancewiththestandard.1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafety,health,andenvironmentalpracticesanddeter-minetheapplicabilityofregulatorylimitationspriortouse.1.4Thisinternationalstandardwasdevelopedinaccor-dancewithinternationallyrecognizedprinciplesonstandard-izationestablishedintheDecisiononPrinciplesfortheDevelopmentofInternationalStandards,GuidesandRecom-mendationsissuedbytheWorldTradeOrganizationTechnicalBarrierstoTrade(TBT)Committee.2.ReferencedDocuments2.1ASTMStandards:2D996TerminologyofPackagingandDistributionEnviron-ments2.2OtherStandard:PantoneMatchingSystem33.Terminology3.1Definitions—Generaldefinitionsforpackaginganddis-tributionenvironmentsarefoundinTerminologyD996.4.SizeandBackgroundColorRequirements4.1LabelSize—Thelabelsshallhaveanominallengthof25to35mmandawidthof10to13mm.4.2LabelBackgroundColor—ThecolorsandpatternsgiveninFig.1shallbeusedtodistinguishthesegroupsofdrugs.Thebackgroundcolorshallnotinterferewiththeabilityoftheusertowriteinformationonthelabel.4.2.1Antagonists—Todenoteanantagonist,1-mmwidediagonalstripesoftheagonistcoloralternatingwitha1-mmwidewhitestripesh...
