Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

16-01-2019

Publisher

American Society for Testing and Materials

This guide discusses information relevant to the immobilization or encapsulation of living cells or tissue in alginate gels.

1.1This guide discusses information relevant to the immobilization or encapsulation of living cells or tissue in alginate gels. Immobilized or encapsulated cells are suitable for use in biomedical and pharmaceutical applications, or both, including, but not limited to, Tissue Engineered Medical Products (TEMPs).

1.2This guide addresses key parameters relevant for successful immobilization and encapsulation in alginate gels.

1.3The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

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.

Committee	F 04
DocumentType	Guide
Pages	8
ProductNote	This standard is also refers to USP 40/NF35,CFR 21PART 312
PublisherName	American Society for Testing and Materials
Status	Current
Supersedes	ASTM F 2315 : 2011

ASTM F 2900 : 2011	Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020)
ASTM F 2739 : 2016	Standard Guide for Quantifying Cell Viability within Biomaterial Scaffolds
ASTM F 2064 : 2017	Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
ASTM F 2605 : 2016	Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
ASTM F 2739 : 2019	Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds

ASTM F 1904 : 1998 : R2003	Standard Practice for Testing the Biological Responses to Particles In Vivo
ASTM F 1906 : 1998	Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration
ASTM F 2312 : 2004	Standard Terminology Relating to Tissue Engineered Medical Products
ASTM F 1904 : 1998 : EDT 1	Standard Practice for Testing the Biological Responses to Particles In Vivo
ASTM F 1903 : 2010	Standard Practice for Testing For Biological Responses to Particles <i>In Vitro</i>
ASTM F 2064 : 2000 : R2006	Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Products Application
ASTM F 1904 : 2023	Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products <emph type="ital">in vivo</emph>
ASTM F 1904 : 2014	Standard Practice for Testing the Biological Responses to Particles <emph type="bdit" >in vivo</emph>
ASTM F 1905 : 1998	Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity
ASTM F 2064 : 2000 : R2006 : EDT 1	Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Products Application
ASTM F 2064 : 2014	Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
ASTM F 2312 : 2011	Standard Terminology Relating to Tissue Engineered Medical Products
ASTM F 2064 : 2000	Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Products Application
ASTM F 2312 : 2011 : R2020	Standard Terminology Relating to Tissue Engineered Medical Products
ASTM F 1904 : 1998 : R2008	Standard Practice for Testing the Biological Responses to Particles <i>in vivo</i>
ASTM F 1903 : 1998	Standard Practice for Testing for Biological Responses to Particles In Vitro
ASTM F 1905 : 1998 : R2003	Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity (Withdrawn 2011)
ASTM F 2064 : 2017	Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
ASTM F 1903 : 2018	Standard Practice for Testing for Cellular Responses to Particles <emph type="bdit" >in vitro</emph>
ASTM F 2312 : 2010	Standard Terminology Relating to Tissue Engineered Medical Products
ASTM F 1906 : 1998 : R2003	Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration (Withdrawn 2011)
ASTM F 2312 : 2003	Standard Terminology Relating to Tissue Engineered Medical Products

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ASTM F 2315 : 2018

Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels

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