ASTM F3163-22
Standard Guide for Categories and Terminology of Cellular and/or Tissue-Based Products (CTPs) for Skin Wounds

Standard No.

ASTM F3163-22

Release Date

2022

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F3163-22

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.

ASTM F3163-22 Referenced Document

• ASTM F2027 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• ASTM F2150 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
• ASTM F2311 Standard Guide for Classification of Therapeutic Skin Substitutes*， 2024-04-21 Update
• ASTM F2312 Standard Terminology Relating to Tissue Engineered Medical Products
• ASTM F2739 Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds

ASTM F3163-22 history

• 2022 ASTM F3163-22 Standard Guide for Categories and Terminology of Cellular and/or Tissue-Based Products (CTPs) for Skin Wounds
• 2016 ASTM F3163-16 Standard Guide for Classification of Cellular and/or Tissue-Based Products (CTPs) for Skin Wounds