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This guide defined terminology and provided classification for products that can be substituted for tissue grafts of human or animal tissue in medical and surgical therapies of skin lesions.
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this guide was withdrawn in April 2017 in accordance with section 10.5.3.1 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.
1.1 This guide defines terminology and provides classification for products that can be substituted for tissue grafts of human or animal tissue in medical and surgical therapies of skin lesions.
1.2 This guide provides a classification method for skin substitutes by comparing their clinical uses with those of conventional tissue grafts. However, skin substitutes may also have equivalent, superior, or inferior clinical properties in comparison to conventional tissue grafts. Clinical classification is independent of the materials and technology used to make a skin substitute, or whether its components include human or animal tissue or other biological or non-biological materials.
1.3 This guide also describes a nomenclature for systematic description of the technologies and components of skin substitutes that is independent of their clinical utilities. This systematic nomenclature is not intended to be prescriptive for product labeling, and it describes only the most salient characteristics of skin substitutes; the actual biological and clinical functions of skin substitutes can depend on characteristics not recognized in the nomenclature, and it should be understood that two products that can be described identically by the nomenclature should not be presumed to be identical or have the same clinical utility.
1.4 This guide does not provide a correspondence between the skin substitute composition and the clinical classification. Also, more than one product may be suitable for each clinical use, and one product may have more than one clinical use.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
F2027 Guide for Characterization and Testing of Raw or Starting Biomaterials for Tissue-Engineered Medical Products
F2150 Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
F2210 Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products
F2312 Terminology Relating to Tissue Engineered Medical Products
Other ReferenceDorland’s Illustrated Medical Dictionary, 29th Ed., W. B. Saunders Company, Philadelphia, 2000.
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ASTM F2311-08, Standard Guide for Classification of Therapeutic Skin Substitutes (Withdrawn 2017), ASTM International, West Conshohocken, PA, 2008, www.astm.orgBack to Top