ASTM F 2064 : 2000 : R2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Products Application
Hardcopy , PDF
11-11-2014
English
01-03-2006
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
F 04
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| DocumentType |
Guide
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| Pages |
8
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| ProductNote |
Reconfirmed 2006
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| PublisherName |
American Society for Testing and Materials
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| Status |
Superseded
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| SupersededBy | |
| Supersedes |
1.1 This guide covers the evaluation of alginates suitable for use in biomedical or pharmaceutical applications, or both, including, but not limited to, tissue-engineered medical products (TEMPS).
1.2 This guide addresses key parameters relevant for the functionality, characterization, and purity of alginates.
1.3 As with any material, some characteristics of alginates may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this polymer should be evaluated using test methods that are appropriate to ensure safety and efficacy and are not addressed in this guide.
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 limitations prior to use.
| ASTM F 2027 : 2016 | Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
| ASTM F 2211 : 2013 | Standard Classification for Tissue Engineered Medical Products (TEMPs) |
| 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 2900 : 2011 | Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020) |
| ASTM F 2259 : 2010 : R2012 : EDT 1 | Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (<sup>1</sup>H NMR) Spectroscopy (Withdrawn 2021) |
| ASTM F 2315 : 2018 | Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels |
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