Standard Historical Last Updated: Aug 16, 2017 Track Document
ASTM F2311-03

Standard Guide for Classification of Therapeutic Skin Substitutes

Standard Guide for Classification of Therapeutic Skin Substitutes F2311-03 ASTM|F2311-03|en-US Standard Guide for Classification of Therapeutic Skin Substitutes Standard new BOS Vol. 13.01 Committee F04
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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.

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Details
Book of Standards Volume: 13.01
Developed by Subcommittee: F04.41
Pages: 5
DOI: 10.1520/F2311-03
ICS Code: 11.120.99