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ASTM F 3504 : 2021

Current

Current

The latest, up-to-date edition.

Standard Practice for Quantifying Cell Proliferation in 3D Scaffolds by a Nondestructive Method

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

03-11-2021

€56.53
Excluding VAT

Committee
F 04
DocumentType
Standard Practice
Pages
7
PublisherName
American Society for Testing and Materials
Status
Current

1.1This practice describes how to conduct a nondestructive proliferation test for mammalian cells based on metabolic activity that can be used to assess the number of viable cells within three-dimensional (3D) scaffolds for regenerative medicine and in tissue-engineered medical products (TEMPs).

1.2This practice provides a detailed explanation of the resazurin cell metabolic activity method in terms of reagent concentrations, incubation times, cell culture media composition, calibration curve, controls, assay linearity, and limitations of the assay.

1.3This practice describes factors that can interfere with accurate cell proliferation assessment.

1.4Since the assay has washing steps, it is limited to assessing cells that are immobilized, such as by adhesion to a culture dish, adhesion to a scaffold, or encapsulation in a hydrogel.

1.5The assay is limited to cell types that can metabolize resazurin to provide a signal in the assay.

1.6This document does not propose acceptance criteria for a cell-based product based on the application of a cell proliferation test method.

1.7This 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.

1.8This 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 2312 : 2024 Standard Terminology Relating to Tissue Engineered Medical Products
ASTM F 3163 : 2016 Standard Guide for Classification of Cellular and/or Tissue-Based Products (CTPs) for Skin Wounds
ASTM F 3163 : 2022 Standard Guide for Categories and Terminology of Cellular and/or Tissue-Based Products (CTPs) for Skin Wounds
ASTM F 3294 : 2018 : R2024 Standard Guide for Performing Quantitative Fluorescence Intensity Measurements in Cell-based Assays with Widefield Epifluorescence Microscopy
ASTM F 2312 : 2011 : R2020 Standard Terminology Relating to Tissue Engineered Medical Products
ASTM F 3294 : 2018 Standard Guide for Performing Quantitative Fluorescence Intensity Measurements in Cell-based Assays with Widefield Epifluorescence Microscopy

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