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ASTM F 2312 : 2011 : R2020

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Standard Terminology Relating to Tissue Engineered Medical Products

Available format(s)

Hardcopy , PDF

Superseded date

23-10-2024

Superseded by

ASTM F 2312 : 2024

Language(s)

English

Published date

01-02-2020

€67.30
Excluding VAT

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Superseded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.

ASTM F 3368 : 2019 Standard Guide for Cell Potency Assays for Cell Therapy and Tissue Engineered Products
ASTM F 2791 : 2015 Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
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)
ASTM F 3106 : 2014 Standard Guide for <emph type="bdit">in vitro</emph> Osteoblast Differentiation Assays
ASTM F 2664 : 2019 : EDT 1 Standard Guide for Assessing the Attachment of Cells to Biomaterial Surfaces by Physical Methods
ASTM F 3223 : 2017 Standard Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction
ASTM F 3224 : 2017 Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonance Imaging
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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