Designation:D3475−15StandardClassificationofChild-ResistantPackages1ThisstandardisissuedunderthefixeddesignationD3475;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisclassificationcoversvarioustypesofchild-resistantpackages.1.2Theexamplesforeachtypeofchild-resistantpackagingarenotintendedtobeall-inclusive,butareincludedonlyasanaidintheunderstandingandcomprehensionofeachtypeofclassification.1.3ListingsarenottobeconsideredendorsementsorapprovalofthepackagebyASTM.2.Terminology2.1DefinitionsofTermsSpecifictoThisStandard:2.1.1child-resistantpackage—asdefinedbythePoisonPreventionPackagingAct,packagingthatisdesignedorconstructedtobesignificantlydifficultforchildrenunderfiveyearsofagetoopenorobtainatoxicorharmfulamountofthesubstancecontainedthereinwithinareasonabletime,andnotdifficultfornormaladultstouseproperly,butdoesnotmeanpackagingwhichallsuchchildrencannotopenorobtainatoxicorharmfulamountwithinareasonabletime.22.1.2unitdosepackage—animmediateproductcontainer/packagedesignedandlabeledinsuchamannerthateachindividualproductpackageisintendedtobeopenedorusedonetimeinagenerallynon-reclosableornon-resealablemanner,separatelyfromtheotherindividualproductunitsinthepackage,ortheentirecontentsofasingleunitpackageintendedforuseinoneapplication.2.1.2.1Discussion—Normallyusedforpharmaceutical,hu-manhealthcare,andnutritionalproductsindrysolid,topical,transdermal,orliquidform.Aunitofsalepackagemaycontainoneormoreindividualunitdosepackages,thatis,individuallywrappedtransdermalpatches,pre-filledsyringesandsyringecartridges,blistercardswithmultipletabletsorcapsules,andsoforth.Unitdosepackagesmayormaynotbechild-resistantinaccordancewiththeregulatoryrequirementsofthepackagecontents.2.1.3unituse/singleusepackage—animmediateproductcontainer/package,whichmayincludel...
