ASTM F 2312 : 2011 : R2020
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Standard Terminology Relating to Tissue Engineered Medical Products
Hardcopy , PDF
23-10-2024
English
01-02-2020
Committee |
F 04
|
DocumentType |
Reference Material
|
Pages |
9
|
ProductNote |
THIS STANDARD IS ALSO REFERS TO 21 CFR Parts 16 and 1270, 21 CFR Parts 207, 807, and 1271
|
PublisherName |
American Society for Testing and Materials
|
Status |
Superseded
|
SupersededBy | |
Supersedes |
1.1This terminology defines basic terms and presents the relationships of the scientific fields related to Tissue Engineered Medical Products (TEMPs). Committee F04 has defined these terms for the specific purpose of unifying the language used in standards for TEMPs.
1.2The terms and relationships defined here are limited to TEMPs. They do not apply to any medical products of human origin regulated by the U.S. Food and Drug Administration under 21 CFR Parts 16 and 1270 and 21 CFR Parts 207, 807, and 1271.
1.3The terms and nomenclature presented in this standard are for the specific purposes of unifying the language used in TEMP standards and are not intended for labeling of regulated medical products.
1.4This 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.
1.5This 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.
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ASTM F 2997 : 2013 | Standard Practice for Quantification of Calcium Deposits in Osteogenic Culture of Progenitor Cells Using Fluorescent Image Analysis |
ASTM F 3225 : 2017 | Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs) |
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ASTM F 3369 : 2019 : EDT 1 | Standard Guide for Assessing the Skeletal Myoblast Phenotype |
ASTM F 3142 : 2016 | Standard Guide for Evaluation of <emph type="bdit">in vitro</emph> Release of Biomolecules from Biomaterials Scaffolds for TEMPs |
ASTM F 2315 : 2018 | Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels |
ASTM F 3209 : 2016 | Standard Guide for Autologous Platelet-Rich Plasma for Use in Tissue Engineering and Cell Therapy |
ASTM F 3163 : 2016 | Standard Guide for Classification of Cellular and/or Tissue-Based Products (CTPs) for Skin Wounds |
ASTM F 3209 : 2024 | Standard Guide for Autologous Platelet-Rich Plasma for Use in Tissue Engineering and Cell Therapy |
ASTM F 3106 : 2022 | Standard Guide for <emph type="bdit"> in vitro</emph> Osteoblast Differentiation Assays |
ASTM F 2150 : 2019 | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products |
ASTM F 2791 : 2024 | Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions |
ASTM F 3274 : 2021 | Standard Guide for Testing and Characterization of Alginate Foam Scaffolds Used in Tissue-Engineered Medical Products (TEMPs) |
ASTM F 3504 : 2021 | Standard Practice for Quantifying Cell Proliferation in 3D Scaffolds by a Nondestructive Method |
ASTM F 3225 : 2017 : R2022 | Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs) |
ASTM F 2997 : 2021 | Standard Practice for Quantification of Calcium Deposits in Osteogenic Culture of Progenitor Cells Using Fluorescent Image Analysis |
ASTM F 3163 : 2022 | Standard Guide for Categories and Terminology of Cellular and/or Tissue-Based Products (CTPs) for Skin Wounds |
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