ASTM F2315-18 PDF

Scope: 1.1 This 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). 1.2 This guide addresses key parameters relevant for successful immobilization and encapsulation in alginate gels. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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 F2315-18 Referenced Document

ASTM F1903 Standard Practice for Testing for Biological Responses to Particles In Vitro
ASTM F1904 Standard Practice for Testing the Biological Responses to Particles In Vivo
ASTM F1905 Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity
ASTM F1906 Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration
ASTM F2064 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
ASTM F2312 Standard Terminology Relating to Tissue Engineered Medical Products*， 2020-02-01 Update
ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products*， 2019-11-26 Update

2018 ASTM F2315-18 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
2011 ASTM F2315-11 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
2010 ASTM F2315-10 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
2003 ASTM F2315-03 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels