ASTM F2311-03
Historical Standard: ASTM F2311-03 Standard Guide for Classification of Therapeutic Skin Substitutes
SUPERSEDED (see Active link, below)
ASTM F2311
1. Scope
1.1 This guide defines terminology and provides a system of classification for products that can be substituted for human or animal skin grafts (or grafts of the dermal or epidermal component tissues of skin) in medical and surgical therapies. This guide is intended to include (or be expandable to) possible future tissue engineered skin technology that could provide novel or superior therapeutic properties to those of natural skin grafts.
1.2 As much as possible, terminology is based on medical dictionary definitions.
1.3 Substitutes for skin grafts are classified by clinical utility only; the classification is independent of the technology used to make a skin substitute, its components, or whether the sources of components include human or animal tissue or other biological or non-biological materials.
1.4 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 requirements 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.
ASTM Standards
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 Reference
Dorlands Illustrated Medical Dictionary, 29th Ed., W. B. Saunders Company, Philadelphia, 2000.Keywords
skin graft; skin substitutes; surgery; tissue engineering; tissue regeneration; wound healing; Classification (standards)--medical/surgical applications; Skin graft/substitutes; Skin; Surgical tissue applications; TEMPs (tissue engineered medical products); Therapeutic skin substitutes; Tissue repair/regeneration; Wound healing;
ICS Code
ICS Number Code 11.120.99 (Other standards related to pharmaceutics)
DOI: 10.1520/F2311-03
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