ASTM F2311-2006 治疗上用皮肤代用品分类的标准指南

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【英文标准名称】:StandardGuideforClassificationofTherapeuticSkinSubstitutes
【原文标准名称】:治疗上用皮肤代用品分类的标准指南
【标准号】:ASTMF2311-2006
【标准状态】:现行
【国别】:
【发布日期】:2006
【实施或试行日期】:
【发布单位】:美国材料与试验协会(ASTM)
【起草单位】:F04.41
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:分类;实验室医学;皮肤;代替品;治疗学
【英文主题词】:tissueengineering;tissueregeneration;skingraft;skinsubstitutes;surgery;woundhealing;
【摘要】:Thisguideisintendedtoprovidethefoundationofstandardsforclinicalassessment,clinicalperformance,andpreclinicalassessmentofsubstitutesforskingrafts.Thisguideisintendedtoaidaccurateclaimsandlabelingfortheclinicalutilitiesofsubstitutesforskingraftsinregulatoryreviews.Inthisguide,x201C;replacementx201D;andx201C;substitutex201D;havedifferentmeanings,althoughtheycanbeusedsynonymouslyinordinaryEnglish.x201C;Replacementx201D;isusedonlyasanadjectiveinthecontextofx201C;skinreplacementsurgery,x201D;whichisdefinedin.x201C;Substitutex201D;isusedonlyasanouninthecontextofx201C;skinsubstitute,x201D;whichisdefinedin2.1.7.11.1.1Thisguidedefinesterminologyandprovidesasystemofclassificationforproductsthatcanbesubstitutedforhumanoranimalskingrafts(orgraftsofthedermalorepidermalcomponenttissuesofskin)inmedicalandsurgicaltherapies.Thisguideisintendedtoinclude(orbeexpandableto)possiblefuturetissueengineeredskintechnologythatcouldprovidenovelorsuperiortherapeuticpropertiestothoseofnaturalskingrafts.1.2Asmuchaspossible,terminologyisbasedonmedicaldictionarydefinitions.1.3Substitutesforskingraftsareclassifiedbyclinicalutilityonly;theclassificationisindependentofthetechnologyusedtomakeaskinsubstitute,itscomponents,orwhetherthesourcesofcomponentsincludehumanoranimaltissueorotherbiologicalornon-biologicalmaterials.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatoryrequirementspriortouse.
【中国标准分类号】:C36
【国际标准分类号】:11_120_99
【页数】:5P.;A4
【正文语种】: