ASTM F3163-22
(Guide)Standard Guide for Categories and Terminology of Cellular and/or Tissue-Based Products (CTPs) for Skin Wounds
Standard Guide for Categories and Terminology of Cellular and/or Tissue-Based Products (CTPs) for Skin Wounds
SIGNIFICANCE AND USE
4.1 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.
4.2 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 Guide F2311) are the same as those used in CTPs, there has been confusion as to how to classify these products.
4.3 This guide is distinguished from Guide 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 TEMPs (tissue-engineered medical products) that are primarily defined by their composition and comprise viable and/or nonviable human or animal cells, viable and/or nonviable tissues, and may include extracellular matrix components. CTPs may additionally include synthetic components.
1.2 This guide also describes categories and terminology for CTPs based on their composition. This systematic categorization 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 categorization and it should be understood that two products that can be described identically by the categorization 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 guide 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 involved in the development of said products in accordance with applicable regulatory guidance documents and in implementing this guide to evaluate the cellular and/or tissue-based products for wounds.
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
General Information
Relations
Buy Standard
Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F3163 − 22
Standard Guide for
Categories and Terminology of Cellular and/or Tissue-Based
1
Products (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* 1.6 This international standard was developed in accor-
dance with internationally recognized principles on standard-
1.1 This guide defines terminology for description of cellu-
ization established in the Decision on Principles for the
lar and/or tissue-based products (CTPs) for skin wounds. CTPs
Development of International Standards, Guides and Recom-
are TEMPs (tissue-engineered medical products) that are
mendations issued by the World Trade Organization Technical
primarily defined by their composition and comprise viable
Barriers to Trade (TBT) Committee.
and/or nonviable human or animal cells, viable and/or nonvi-
able tissues, and may include extracellular matrix components.
2. Referenced Documents
CTPs may additionally include synthetic components.
2
2.1 ASTM Standards:
1.2 Thisguidealsodescribescategoriesandterminologyfor
F2027 Guide for Characterization and Testing of Raw or
CTPs based on their composition. This systematic categoriza-
Starting Materials for Tissue-Engineered Medical Prod-
tion is not intended to be prescriptive for product labeling, and
ucts
it describes only the most salient characteristics of these
F2150 Guide for Characterization and Testing of Biomate-
products; the actual biological and clinical functions can
rial Scaffolds Used in Regenerative Medicine and Tissue-
depend on characteristics not recognized in the categorization
Engineered Medical Products
and it should be understood that two products that can be
F2311 Guide for Classification of Therapeutic Skin Substi-
described identically by the categorization should not be 3
tutes (Withdrawn 2017)
presumed to be identical or have the same clinical utility.
F2312 Terminology Relating to Tissue Engineered Medical
1.3 This guide defines CTP-related terminology in the
Products
context of skin wounds. However, this guide does not provide F2739 Guide for Quantifying Cell Viability and Related
acorrespondencebetweentheCTPcompositionanditsclinical
Attributes within Biomaterial Scaffolds
use(s). More than one product may be suitable for each clinical
3. Terminology
use, and one product may have more than one clinical use.
3.1 Skin Tissue Definitions:
1.4 This guide does not purport to address safety concerns
4
3.1.1 dermal, adj—pertaining to the dermis (1).
with the use of CTPs. It is the responsibility of the user of this
standard to establish appropriate safety and health practices
3.1.2 dermis, n—the layer of the skin underneath the
involved in the development of said products in accordance epidermis,consistingofadensebedofvascularizedconnective
with applicable regulatory guidance documents and in imple-
tissue (1).
menting this guide to evaluate the cellular and/or tissue-based
3.1.3 dermoepidermal junction (DEJ), n—distinct anatomic
products for wounds.
zone between the epidermis and dermis that facilitates adher-
1.5 This standard does not purport to address all of the ence between the two layers; contains laminin, collagen type
safety concerns, if any, associated with its use. It is the
VII, collagen type IV, and tenascin C (2).
responsibility of the user of this standard to establish appro-
3.1.4 epidermal, adj—pertaining to or resembling epidermis
priate safety, health, and environmental practices and deter-
(1).
mine the applicability of regulatory limitations prior to use.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and Standards volume information, refer to the standard’s Document Summary page on
Surgical Materials and Devices and is the direct responsibility of Subcommittee the ASTM website.
3
F04.41 on Classification and Terminology for TEMPs. The last approved version of this historical standard is referenced on
Current edition approved Feb. 15, 2022. Published March 2022. Originally www.astm.org.
4
approved in 2016. Last previous edition approved in 2016 as F3163 – 16. DOI: The boldface numbers in parentheses refer to the list of references at the end of
10.1520/F3163-22. this standard.
*A Summary of Changes section appears at the end of
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F3163 − 16 F3163 − 22
Standard Guide for
Classification Categories and Terminology of Cellular and/or
1
Tissue-Based Products (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 Scope*
1.1 This guide defines terminology for description of cellular and/or tissue-based products (CTPs) for skin wounds. CTPs are
defined primarily TEMPs (tissue-engineered medical products) that are primarily defined 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. viable and/or nonviable
human or animal cells, viable and/or nonviable tissues, and may include extracellular matrix components. 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 categories and nomenclatureterminology for CTPs based on their composition. This
systematic nomenclaturecategorization 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,categorization and it should be understood that two products that can be described identically by the nomencla-
turecategorization 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 guide 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 involved in the development of said products in accordance with applicable
regulatory guidance documents and in implementing this guide to evaluate the cellular and/or tissue-based products for wounds.
1.5 This standard does not purport to address safety concerns with the use of CTPs. 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 safety, health, and
healthenvironmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
1
This test method guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.41 on Classification and Terminology for TEMPs.
Current edition approved Jan. 1, 2016Feb. 15, 2022. Published February 2016March 2022. Originally approved in 2016. Last previous edition approved in 2016 as
F3163 – 16. DOI: 10.1520/F3163-1610.1520/F3163-22.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F3163 − 22
2. Referenced Documents
2
2.1 ASTM Standards:
F2027 Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
F2150 Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered
Medical Products
3
F2311 Guide for Classification of Therapeutic Skin Substitutes (Withdrawn 2017)
F2312 Terminology Relating to Tissue Engineered Medical Products
F2739 Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds
3. Terminology
3
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.