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Significance and Use
As much as possible, terminology contained herein is based on medical dictionary definitions.
This guide provides nomenclature and classifications to accurately and unambiguously describe tissue engineered skin substitutes as well as their clinical functions. These classification systems and their nomenclature are not intended to be prescriptive for product labeling or advertising.
In this guide, “replacement” and “substitute” have different meanings, although they can be used synonymously in ordinary English. “Skin substitute,” which is defined in 3.5.2, is a tissue-engineered medical product that a physician or surgeon can use in a medical or surgical procedure. “Skin replacement,” which is defined in 3.7.7, is the therapeutic outcome of successful skin replacement surgery, but this is only one of several clinical uses for skin substitutes.
Skin substitutes are used in different medical settings and by different medical and surgical specialties. In order to help clarify the clinical applications of skin substitutes, a discussion of common medical and surgical procedures that use conventional skin tissue grafts (autograft and fresh or frozen allograft and xenograft) is provided in Section 6. This discussion is intended provide context for understanding the categories of Section 7, which model clinical uses of skin substitutes by comparison with the uses of conventional skin grafts. However, the procedures, circumstances, and surgical intentions in section are not intended to limit the possible uses of skin substitutes, nor is the classification in section intended to limit the uses of skin substitutes to only those uses of conventional skin graft tissues.
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.
ICS Number Code 11.120.99 (Other standards related to pharmaceutics)
UNSPSC Code 42321503(Bone graft extender or substitute); 85000000(Healthcare Services)