ASTM F2315-10
Historical Standard: ASTM F2315-10 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
SUPERSEDED (see Active link, below)
ASTM F2315
1. 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 and health practices and determine the applicability of regulatory requirements prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ASTM Standards
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F1251 Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
F1903 Practice for Testing For Biological Responses to Particles In Vitro
F1904 Practice for Testing the Biological Responses to Particles in vivo
F1905 Practice For Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity
F1906 Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte Proliferation, and Cell Migration
F2064 Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Products Application
USP Document
USPMonographUSP24/NF Sodium Alginate Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, http://www.usp.org.Other Referenced Documents
InternationalConfere A Standard Battery for Genotoxicity Testing of Pharmaceuticals (July 1997) Available from ICH Secretariat, c/o IFPMA, 30 rue de St-Jean, P.O. Box 758, 1211 Geneva 13, Switzerland.Keywords
Bead formation; Composition analysis; Alginates; Encapsulants/encapsulation; Gelation analysis; Immobilization; Ion concentration; Matrix data/programs; Microencapsulated cells; Pain analysis/reduction; Parkinson's disease; TEMPs (tissue engineered medical products);
ICS Code
ICS Number Code 11.120.99 (Other standards related to pharmaceutics)
DOI: 10.1520/F2315-10
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