ASTM_F_2311_-_08.pdf

Designation:F231108Standard Guide forClassification of Therapeutic Skin Substitutes1This standard is issued under the fixed designation F2311;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide defines terminology and provides classifica-tion for products that can be substituted for tissue grafts ofhuman or animal tissue in medical and surgical therapies ofskin lesions.1.2 This guide provides a classification method for skinsubstitutes by comparing their clinical uses with those ofconventional tissue grafts.However,skin substitutes may alsohave equivalent,superior,or inferior clinical properties incomparison to conventional tissue grafts.Clinical classificationis independent of the materials and technology used to make askin substitute,or whether its components include human oranimal tissue or other biological or non-biological materials.1.3 This guide also describes a nomenclature for systematicdescription of the technologies and components of skin substi-tutes that is independent of their clinical utilities.This system-atic nomenclature is not intended to be prescriptive for productlabeling,and it describes only the most salient characteristicsof skin substitutes;the actual biological and clinical functionsof skin substitutes can depend on characteristics not recognizedin the nomenclature,and it should be understood that twoproducts that can be described identically by the nomenclatureshould not be presumed to be identical or have the sameclinical utility.1.4 This guide does not provide a correspondence betweenthe skin substitute composition and the clinical classification.Also,more than one product may be suitable for each clinicaluse,and one product may have more than one clinical use.1.5 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2F2027 Guide for Characterization and Testing of Raw orStarting Biomaterials for Tissue-Engineered MedicalProductsF2150 Guide for Characterization and Testing of Biomate-rial Scaffolds Used in Tissue-Engineered Medical Prod-uctsF2210 Guide for Processing Cells,Tissues,and Organs forUse in Tissue Engineered Medical ProductsF2312 Terminology Relating to Tissue Engineered MedicalProducts2.2 Other Reference:Dorlands Illustrated Medical Dictionary,29th Ed.,W.B.Saunders Company,Philadelphia,2000.3.Terminology3.1 Skin Tissue Definitions:3.1.1 dermal,adjpertaining to the dermis.Dorlands3.1.1.1 DiscussionIn this guide,to avoid confusion,“der-mal”is preferred to be used to refer only to a patients existingor regenerated tissue and not to dermal tissue when used as acomponent of a skin substitute.Exceptions are“dermal au-tograft”and“dermal autograft substitute.”3.1.2 dermis,nthe layer of the skin deep to the epidermis,consisting of a dense bed of vascular connective tissue.Dorlands3.1.3 epidermal,adjpertainingtoorresemblingepidermis.Dorlands3.1.3.1 DiscussionIn this guide,to avoid confusion,“epi-dermal”is used to refer only to the patients existing orregenerated tissue and not to epidermal tissue used as acomponent of a skin substitute.Exceptions are“epidermalautograft”and“epidermal autograft substitute.”3.1.4 epidermis,nthe outermost and nonvascular layer ofthe skin.Dorlands1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.41 on Classification and Terminology for TEMPs.Current edition approved Oct.1,2008.Published November 2008.Originallyapproved in 2003.Last previous edition approved in 2006 as F2311 06.DOI:10.1520/F2311-08.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.5 skin,nthe outer integument or covering of the body,consisting of the dermis and the epidermis,and resting uponthe subcutaneous tissues.F23123.1.6 tissue,nan aggregation of similarly specialized cellsunited in the performance of a particular function.In general,a tissue contains an extracellular matrix,in addition to special-ized cells.F23123.2 Skin Wound and Ulcer Definitions:3.2.1 excised skin wound,na full or deep partial thicknessopen skin wound that has been created by surgery and that isfree of foreign matter,necrotic and devitalized tissue,andmicrobial contamination,has no punctuate