ASTM F3106-22 PDF

Scope: 1.1 This document provides guidance on how to conduct in vitro osteoblast differentiation assays with progenitor stem cells including mesenchymal stromal cells. 1.2 This document describes the roles of various osteogenic supplements that are added to the cell culture medium of an osteoblast differentiation assay to encourage and support the differentiation of progenitor cells into matrix-producing osteoblasts. 1.3 This document provides recommendations for the concentrations of osteogenic supplements that may prevent the precipitation of artifactual mineral deposits that are not directly produced by osteoblasts, nor correlated with osteoblastic gene expression of the cells. 1.4 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. 1.5 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 F3106-22 Referenced Document

ASTM F2312 Standard Terminology Relating to Tissue Engineered Medical Products
ASTM F2944 Standard Practice for Automated Colony Forming Unit (CFU) Assays—Image Acquisition and Analysis Method for Enumerating and Characterizing Cells and Colonies in Culture
ASTM F2997 Standard Practice for Quantification of Calcium Deposits in Osteogenic Culture of Progenitor Cells Using Fluorescent Image Analysis*， 2024-04-21 Update
ISO 21709 Biotechnology - Biobanking - Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines; Amendment 1

2022 ASTM F3106-22 Standard Guide for in vitro Osteoblast Differentiation Assays
2014 ASTM F3106-14 Standard Guide for in vitro Osteoblast Differentiation Assays