ASTM F3163-16

Standard Guide for Classification of Cellular and/or Tissue-Based Products (CTPs) for Skin Wounds

SIGNIFICANCE AND USE
5.1 This guide provides definitions and a classification for CTPs, as well as definitions related to skin tissue, skin wounds and ulcers, wound healing physiology, wound covers, and related medical and surgical procedures. This guide is not intended to prescribe or limit the clinical uses of these products.  
5.2 One objective of the current guide is to include the wide range of CTPs for which there is a rationale for benefit beyond that achievable with conventional wound coverings. Whether an individual CTP is capable of promoting wound healing must be determined by adequate evidence and is beyond the scope of this standard. Given that some of the materials used in dressings and skin substitutes (defined in ASTM Standard F2311) are the same as those used in CTPs, there has been confusion as to how to classify these products.  
5.3 This guide is distinguished from ASTM Standard F2311, which defines terminology and provides classification by clinical use for products that can be substituted for tissue grafts of human or animal tissue in medical and surgical therapies of skin lesions. In contrast, this guide defines terminology for description of CTPs for skin wounds; CTPs are defined primarily by their composition. Neither guide establishes a correspondence between device structure and clinical function.
SCOPE
1.1 This guide defines terminology for description of cellular and/or tissue-based products (CTPs) for skin wounds. CTPs are defined primarily by their composition and comprise cells and/or the extracellular components of tissue. CTPs may contain cells (viable or nonviable), tissues, proteins, and other materials for which there is a rationale for benefit beyond that achievable with conventional wound coverings. CTPs may additionally include synthetic components. Whether an individual CTP is capable of promoting wound healing must be determined by adequate evidence and is beyond the scope of this standard.  
1.2 This guide also describes a classification and nomenclature for CTPs based on their composition. This systematic nomenclature is not intended to be prescriptive for product labeling, and it describes only the most salient characteristics of these products; the actual biological and clinical functions 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.  
1.3 This guide defines CTP-related terminology in the context of skin wounds. However, this guide does not provide a correspondence between the CTP composition and its clinical use(s). More than one product may be suitable for each clinical use, and one product may have more than one clinical use.  
1.4 This standard does not purport to address safety concerns with the use of CTPs. 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.

General Information

• Status: Historical
• Publication Date: 31-Dec-2015
• ICS: 11.120.20 - Wound dressings and compresses
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.41 - Classification and Terminology for TEMPs

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F3163 −16
Standard Guide for
Classification of Cellular and/or Tissue-Based Products
1
(CTPs) for Skin Wounds
This standard is issued under the fixed designation F3163; 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
1.1 This guide defines terminology for description of cellu- 2.1 ASTM Standards:
lar and/or tissue-based products (CTPs) for skin wounds. CTPs F2027 Guide for Characterization and Testing of Raw or
are defined primarily by their composition and comprise cells Starting Biomaterials for Tissue-Engineered Medical
and/or the extracellular components of tissue. CTPs may Products
contain cells (viable or nonviable), tissues, proteins, and other F2150 Guide for Characterization and Testing of Biomate-
materials for which there is a rationale for benefit beyond that rial Scaffolds Used in Tissue-Engineered Medical Prod-
achievable with conventional wound coverings. CTPs may ucts
additionally include synthetic components. Whether an indi- F2311 Guide for Classification of Therapeutic Skin Substi-
vidual CTP is capable of promoting wound healing must be tutes
determined by adequate evidence and is beyond the scope of F2312 Terminology Relating to Tissue Engineered Medical
this standard. Products
F2739 Guide for Quantitating Cell Viability Within Bioma-
1.2 This guide also describes a classification and nomencla-
terial Scaffolds
ture for CTPs based on their composition. This systematic
nomenclature is not intended to be prescriptive for product
3. Terminology
labeling, and it describes only the most salient characteristics
3.1 Skin Tissue Definitions:
of these products; the actual biological and clinical functions
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3.1.1 dermal, adj—pertaining to the dermis (1).
can depend on characteristics not recognized in the
nomenclature, and it should be understood that two products
3.1.2 dermis, n—the layer of the skin deep to the epidermis,
that can be described identically by the nomenclature should
consisting of a dense bed of vascularized connective tissue (1).
not be presumed to be identical or have the same clinical
3.1.3 dermoepidermal junction (DEJ), n—distinct anatomic
utility.
zone between the epidermis and dermis that facilitates adher-
1.3 This guide defines CTP-related terminology in the ence between the two layers; contains laminin, collagen type
context of skin wounds. However, this guide does not provide VII, collagen type IV, and tenascin C (2).
acorrespondencebetweentheCTPcompositionanditsclinical
3.1.4 epidermal, adj—pertaining to or resembling epidermis
use(s). More than one product may be suitable for each clinical
(1).
use, and one product may have more than one clinical use.
3.1.5 epidermis, n—the outermost and nonvascularized
1.4 This standard does not purport to address safety con-
layer of the skin (1).
cerns with the use of CTPs. It is the responsibility of the user
3.1.6 extracellular matrix, n—a structural and functional
of this standard to establish appropriate safety and health
entity produced by cells that surrounds and supports cells and
practices and determine the applicability of regulatory limita-
tions prior to use.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
and Surgical Materials and Devices and is the direct responsibility of Subcommittee Standards volume information, refer to the standard’s Document Summary page on
F04.41 on Classification and Terminology for TEMPs. the ASTM website.
3
Current edition approved Jan. 1, 2016. Published February 2016. DOI: 10.1520/ The boldface numbers in parentheses refer to the list of references at the end of
F3163-16 this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F3163−16
regulates cell communication. Typical components are 3.2.14 venous leg ulcer, n—ulceration on the leg due to
collagens, adhesive glycoproteins, glycosaminoglycans, and chronic venous insufficiency. Also known as venous stasis
proteoglycans (3). ulcer or venous insufficiency ulcer (5).
3.1.7 skin, n—the outer integument or covering of the body, 3.2.15 wound, n—a disruption of normal anatomic structure
and function of a tissue or organ. Also known as injury or
consisting of the dermis and the epidermis, and resting upon
the subcutaneous tissue. (F2312) trauma(4).
3.2.15.1 Discussion—In this guide, skin woun
...