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ASTM F 3163 : 2016

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Hardcopy , PDF

Superseded date

03-09-2022

Language(s)

English

Published date

02-03-2016

CONTAINED IN VOL. 13.02, 2016 Specifies terminology for description of cellular and/or tissue-based products (CTPs) for skin wounds.

1.1This 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.

1.2This 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.

1.3This 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.

1.4This 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.

Committee
F 04
DocumentType
Guide
Pages
6
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

ASTM F 3504 : 2021 Standard Practice for Quantifying Cell Proliferation in 3D Scaffolds by a Nondestructive Method
ASTM F 3515 : 2021 Standard Guide for Characterization and Testing of Porcine Fibrinogen as a Starting Material for Use in Biomedical and Tissue-Engineered Medical Product Applications

ASTM F 2150 : 2013 : REDLINE Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
ASTM F 2027 : 2000 Standard Guide for Characterization and Testing of Substrate Materials for Tissue-Engineered Medical Products
ASTM F 2312 : 2011 : REDLINE Standard Terminology Relating to Tissue Engineered Medical Products
ASTM F 2150 : 2019 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
ASTM F 2311 : 2003 Standard Guide for Classification of Therapeutic Skin Substitutes
ASTM F 2312 : 2004 Standard Terminology Relating to Tissue Engineered Medical Products
ASTM F 2739 : 2019 Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds
ASTM F 2027 : 2016 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
ASTM F 2739 : 2008 Standard Guide for Quantitating Cell Viability Within Biomaterial Scaffolds
ASTM F 2312 : 2011 Standard Terminology Relating to Tissue Engineered Medical Products
ASTM F 2027 : 2016 : REDLINE Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
ASTM F 2150 : 2013 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
ASTM F 2150 : 2002 : EDT 1 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
ASTM F 2311 : 2008 Standard Guide for Classification of Therapeutic Skin Substitutes (Withdrawn 2017)
ASTM F 2312 : 2011 : R2020 Standard Terminology Relating to Tissue Engineered Medical Products
ASTM F 2027 : 2000 : EDT 1 Standard Guide for Characterization and Testing of Substrate Materials for Tissue-Engineered Medical Products
ASTM F 2027 : 2008 Standard Guide for Characterization and Testing of Raw or Starting Biomaterials for Tissue-Engineered Medical Products
ASTM F 2739 : 2016 Standard Guide for Quantifying Cell Viability within Biomaterial Scaffolds
ASTM F 2312 : 2010 Standard Terminology Relating to Tissue Engineered Medical Products
ASTM F 2311 : 2006 Standard Guide for Classification of Therapeutic Skin Substitutes
ASTM F 2150 : 2007 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
ASTM F 2312 : 2003 Standard Terminology Relating to Tissue Engineered Medical Products

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