ASTM F 2315 : 2018
Current
The latest, up-to-date edition.
Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
Hardcopy , PDF
English
16-01-2019
Important note : Users cannot be edited or removed once added to your Multi user PDF.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 |
Current
|
| 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.
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| 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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