ASTM F2311-06
(Guide)Standard Guide for Classification of Therapeutic Skin Substitutes
Standard Guide for Classification of Therapeutic Skin Substitutes
SIGNIFICANCE AND USE
This guide is intended to provide the foundation of standards for clinical assessment, clinical performance, and preclinical assessment of substitutes for skin grafts.
This guide is intended to aid accurate claims and labeling for the clinical utilities of substitutes for skin grafts in regulatory reviews.
In this guide, “replacement” and “substitute” have different meanings, although they can be used synonymously in ordinary English. “Replacement” is used only as an adjective in the context of “skin replacement surgery,” which is defined in . “Substitute” is used only as a noun in the context of “skin substitute,” which is defined in 2.1.7.11.
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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Standards Content (Sample)
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Designation: F 2311 – 06
Standard Guide for
1
Classification of Therapeutic Skin Substitutes
This standard is issued under the fixed designation F 2311; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope lesion” is intended to encompass skin wounds and skin ulcers.
Dorland’s
1.1 Thisguidedefinesterminologyandprovidesasystemof
2.1.3.3 open wound, n—a wound that communicates with
classification for products that can be substituted for human or
the atmosphere by direct exposure. Dorland’s
animal skin grafts (or grafts of the dermal or epidermal
2.1.3.4 partial thickness skin wound, n—a skin wound with
component tissues of skin) in medical and surgical therapies.
the loss of the epidermis and part of the dermis, but retaining
Thisguideisintendedtoinclude(orbeexpandableto)possible
a layer of viable dermal tissue that includes the sources of
future tissue engineered skin technology that could provide
epidermal cells from which the wound can heal spontaneously
novel or superior therapeutic properties to those of natural skin
by epidermal tissue regeneration.
grafts.
2.1.3.5 ulcer, n—a local defect, or excavation of the surface
1.2 As much as possible, terminology is based on medical
of an organ or tissue, which is produced by the sloughing of
dictionary definitions.
inflammatory necrotic tissue. Dorland’s
1.3 Substitutes for skin grafts are classified by clinical
2.1.3.6 wound, n—an injury or damage, usually restricted to
utility only; the classification is independent of the technology
those caused by physical means with disruption of the normal
used to make a skin substitute, its components, or whether the
continuity of structures. Called also injury and trauma.
sources of components include human or animal tissue or other
Dorland’s
biological or non-biological materials.
2.1.4 Skin Wound Physiology:
1.4 This standard does not purport to address all of the
2.1.4.1 granulations, n—granulation tissue.
safety concerns, if any, associated with its use. It is the
2.1.4.2 granulation tissue, n—the newly formed vascular
responsibility of the user of this standard to establish appro-
tissue normally produced in the healing of wounds of soft
priate safety and health practices and determine the applica-
tissue and ultimately forming the cicatrix [scar]; it consists of
bility of regulatory requirements prior to use.
small, translucent, red, nodular masses or granulations that
2. Terminology
have a velvety appearance. Dorland’s
2.1.4.3 scar, n—fibrous tissue replacing normal tissues de-
2.1 Definitions:
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stroyed by injury or disease. Stedman’s
2.1.1 skin, n—the outer integument or covering of the body,
2.1.4.4 wound contraction, n—the shrinkage and spontane-
consisting of the dermis and the epidermis, and resting upon
ous closure of open skin wounds. Dorland’s
the subcutaneous tissues. Dorland’s
2.1.4.5 wound contracture, n—a condition of fixed high
2.1.2 tissue, n—anaggregationofsimilarlyspecializedcells
resistance to passive stretch of muscle, skin or joints resulting
united in the performance of a particular function.
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from fibrosis and scarring of the skin or the tissues supporting
Dorland’s
the muscles or the joints, or both. (This definition is a
2.1.3 Skin Lesions:
modification of Dorland’s definition of contracture, “a condi-
2.1.3.1 full-thickness skin wound, n—a skin wound with the
tion of fixed high resistance to passive stretch of muscle,
loss of epidermis, and all of the dermis or at least the depth of
resulting from fibrosis of the tissues supporting the muscles or
dermisthatincludesmostorallsourcesofepidermalcellsfrom
the joints, or disorders of the muscle fibers,” because that
epidermal adnexae (glands and follicles).
definition does not address fibrosis and scarring in skin.)
2.1.3.2 lesion, n—any pathological or traumatic discontinu-
2.1.4.6 wound inflammation, n—a localized protective re-
ity of tissue or loss of function of a part. In this guide, “skin
sponse elicited by injury or destruction of tissues, which serves
to destroy, dilute, or wall off (sequester) both the injurious
1
agent and the injured tissue. It is characterized in the acute
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Devices and Materials and is the direct responsibility of Subcommittee form by the classical signs of pain (dolor), heat (calor) redness
F04.41 on Classification and Terminology for TEMPs.
Current edition approved May 1, 2006. Published May 2006. Originally
approved in 2003. Last previous edition approved in 2003 as F 2311 – 03
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Dorland, WAN, Dorland’s Illustrated Medical Dictionary, 2
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