ASTM F 2315 : 2018
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
English
01-11-2018
08-05-2026
This guide discusses information relevant to the immobilization or encapsulation of living cells or tissue in alginate gels.
| 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 |
Superseded
|
| SupersededBy | |
| Supersedes |
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.
| 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 748 : 2016 | Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
| ASTM F 2312 : 2024 | 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 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 2312 : 2011 | Standard Terminology Relating to Tissue Engineered Medical Products |
| 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 748 : 2025 | Standard Practice for Selecting Biological Test Methods for Materials and Devices |
| ASTM F 1905 : 1998 : R2003 | Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity (Withdrawn 2011) |
| ASTM F 1903 : 2018 | Standard Practice for Testing for Cellular Responses to Particles <emph type="bdit" >in vitro</emph> |
| ASTM F 1903 : 2025 | Standard Practice for Testing for Cellular Responses to Particles <emph type="ital" >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 |