Designation:D4775/D4775M−09(Reapproved2014)StandardSpecificationforIdentificationandConfigurationofPrefilledSyringesandDeliverySystemsforDrugs(ExcludingPharmacyBulkPackages)1ThisstandardisissuedunderthefixeddesignationD4775/D4775M;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoverstheidentificationof:1.1.1Thedrugcontainedintheprefilledsyringeordeliverysystem.1.1.2Theconcentration,volume,andtotalamountofthedrug,andwhetheritistobedilutedpriortoadministration.1.2ThevaluesstatedineitherSIunitsorinch-poundunitsaretoberegardedseparatelyasstandard.Thevaluesstatedineachsystemmaynotbeexactequivalents;therefore,eachsystemshallbeusedindependentlyoftheother.Combiningvaluesfromthetwosystemsmayresultinnon-conformancewiththestandard.NOTE1—ThevaluesinSIunitsaretherecommendedvalues.2.ReferencedDocuments2.1ASTMStandards:2D996TerminologyofPackagingandDistributionEnviron-mentsD4267SpecificationforLabelsforSmall-Volume(100mLorLess)ParenteralDrugContainersD7298TestMethodforMeasurementofComparativeLeg-ibilitybyMeansofPolarizingFilterInstrumentation3.Terminology3.1Generaldefinitionsforpackaginganddistributionenvi-ronmentsarefoundinTerminologyD996.3.2DefinitionsofTermsSpecifictoThisStandard:3.2.1deliverysystem—asusedinthisspecification,aclosedsystemconsistingofacontainerofconcentratedsolu-tionorpowderwhichfacilitatesthetransferofthecontentsintoadiluentpriortoadministrationoruse.3.2.2pharmacybulkpackage—drugsuppliedinastockcontainertobeheldinthepharmacyandusedformultipledispensing.3.2.3syringe—aninstrumentbymeansofwhichdrugsinsolutionorotherliquidsareinjectedintoorwithdrawnfromanyvesselorcavity.4.SignificanceandUse4.1Difficultieshaveoccurredinthecorrectidentificationofsyringescontainingsignificantlydifferentmedicationsoncetheyhavebeenremovedfromthei...
