ASTM F2311-08
(Guide)Standard Guide for Classification of Therapeutic Skin Substitutes (Withdrawn 2017)
Standard Guide for Classification of Therapeutic Skin Substitutes (Withdrawn 2017)
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.
SCOPE
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.
WITHDRAWN RATIONALE
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 Regula...
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation:F2311 −08
Standard Guide for
1
Classification of Therapeutic Skin Substitutes
This standard is issued under the fixed designation F2311; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
2
2.1 ASTM Standards:
1.1 This guide defines terminology and provides classifica-
F2027 Guide for Characterization and Testing of Raw or
tion for products that can be substituted for tissue grafts of
Starting Biomaterials for Tissue-Engineered Medical
human or animal tissue in medical and surgical therapies of
Products
skin lesions.
F2150 Guide for Characterization and Testing of Biomate-
1.2 This guide provides a classification method for skin
rial Scaffolds Used in Tissue-Engineered Medical Prod-
substitutes by comparing their clinical uses with those of
ucts
conventional tissue grafts. However, skin substitutes may also
F2210 Guide for Processing Cells, Tissues, and Organs for
have equivalent, superior, or inferior clinical properties in Use in Tissue Engineered Medical Products
F2312 Terminology Relating to Tissue Engineered Medical
comparisontoconventionaltissuegrafts.Clinicalclassification
Products
is independent of the materials and technology used to make a
skin substitute, or whether its components include human or
2.2 Other Reference:
animal tissue or other biological or non-biological materials.
Dorland’s Illustrated Medical Dictionary, 29th Ed., W. B.
Saunders Company, Philadelphia, 2000.
1.3 This guide also describes a nomenclature for systematic
description of the technologies and components of skin substi-
3. Terminology
tutes that is independent of their clinical utilities. This system-
3.1 Skin Tissue Definitions:
atic nomenclature is not intended to be prescriptive for product
3.1.1 dermal, adj—pertaining to the dermis. Dorland’s
labeling, and it describes only the most salient characteristics
3.1.1.1 Discussion—In this guide, to avoid confusion, “der-
of skin substitutes; the actual biological and clinical functions
mal” is preferred to be used to refer only to a patient’s existing
ofskinsubstitutescandependoncharacteristicsnotrecognized
or regenerated tissue and not to dermal tissue when used as a
in the nomenclature, and it should be understood that two
component of a skin substitute. Exceptions are “dermal au-
products that can be described identically by the nomenclature
tograft” and “dermal autograft substitute.”
should not be presumed to be identical or have the same
clinical utility. 3.1.2 dermis, n—the layer of the skin deep to the epidermis,
consisting of a dense bed of vascular connective tissue.
1.4 This guide does not provide a correspondence between
Dorland’s
the skin substitute composition and the clinical classification.
3.1.3 epidermal, adj—pertaining to or resembling
Also, more than one product may be suitable for each clinical
epidermis. Dorland’s
use, and one product may have more than one clinical use.
3.1.3.1 Discussion—In this guide, to avoid confusion, “epi-
1.5 This standard does not purport to address all of the
dermal” is used to refer only to the patient’s existing or
safety concerns, if any, associated with its use. It is the
regenerated tissue and not to epidermal tissue used as a
responsibility of the user of this standard to establish appro-
component of a skin substitute. Exceptions are “epidermal
priate safety and health practices and determine the applica-
autograft” and “epidermal autograft substitute.”
bility of regulatory limitations prior to use.
3.1.4 epidermis, n—the outermost and nonvascular layer of
the skin. Dorland’s
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
2
F04.41 on Classification and Terminology for TEMPs. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Oct. 1, 2008. Published November 2008. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2003. Last previous edition approved in 2006 as F2311 – 06. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2311-08. the ASTM website.
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F2311−08
3.1.5 skin, n—the outer integument or covering of the body, 3.3 Wound Healing Physiology Definitions:
consisting of the dermis and the epidermis, and resting upon
3.3.1 Discussion—In surgical wound closure, an imp
...
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