ASTM WK43184

    New Specification for Classification of Cellular and/or Tissue-Based Products (CTPs) for Wounds

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    Developed by Subcommittee: F04.41 | Committee F04 | Contact Staff Manager


    1. Scope

    This document will address terminology for products that contain living cells or constitute tissue-based products for the management or treatment of skin wounds. This document will also describe a classification and nomenclature for CTPs based on their composition. Products meeting the following three criteria are included in the classification: 1.Are used for the management or treatment of skin wounds. 2.Contain viable (living) cells OR are processed animal or human tissue OR are designed based on essential features of living tissue such as biomechanics, structure, or biochemical composition, inclusive of products derived from biologic, synthetic or biosynthetic materials. 3.Are incorporated into the tissue (eg, through degradation and/or remodeling in vivo). For the purposes of this document, bilayered or multilayered products are considered tissue-based products even if only one layer meets all of the aforementioned criteria.


    Chronic wounds, wound healing, skin wounds, ulcers, matrix, scaffold, cellular therapy, dressings

    The title and scope are in draft form and are under development within this ASTM Committee.

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    Work Item Status

    Date Initiated:

    Technical Contact:
    Charles DRUECK


    F04.41 (15-01)

    Negative Votes Need Resolution