Designation:F2311−08StandardGuideforClassificationofTherapeuticSkinSubstitutes1ThisstandardisissuedunderthefixeddesignationF2311;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisguidedefinesterminologyandprovidesclassifica-tionforproductsthatcanbesubstitutedfortissuegraftsofhumanoranimaltissueinmedicalandsurgicaltherapiesofskinlesions.1.2Thisguideprovidesaclassificationmethodforskinsubstitutesbycomparingtheirclinicaluseswiththoseofconventionaltissuegrafts.However,skinsubstitutesmayalsohaveequivalent,superior,orinferiorclinicalpropertiesincomparisontoconventionaltissuegrafts.Clinicalclassificationisindependentofthematerialsandtechnologyusedtomakeaskinsubstitute,orwhetheritscomponentsincludehumanoranimaltissueorotherbiologicalornon-biologicalmaterials.1.3Thisguidealsodescribesanomenclatureforsystematicdescriptionofthetechnologiesandcomponentsofskinsubsti-tutesthatisindependentoftheirclinicalutilities.Thissystem-aticnomenclatureisnotintendedtobeprescriptiveforproductlabeling,anditdescribesonlythemostsalientcharacteristicsofskinsubstitutes;theactualbiologicalandclinicalfunctionsofskinsubstitutescandependoncharacteristicsnotrecognizedinthenomenclature,anditshouldbeunderstoodthattwoproductsthatcanbedescribedidenticallybythenomenclatureshouldnotbepresumedtobeidenticalorhavethesameclinicalutility.1.4Thisguidedoesnotprovideacorrespondencebetweentheskinsubstitutecompositionandtheclinicalclassification.Also,morethanoneproductmaybesuitableforeachclinicaluse,andoneproductmayhavemorethanoneclinicaluse.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocumen...
