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ASTM F 2103 : 2001

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications

Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Language(s)

English

Published date

10-05-2001

€67.30
Excluding VAT

Committee
F 04
DocumentType
Guide
Pages
8
ProductNote
Reconfirmed 2001
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

1.1 This guide covers the evaluation of chitosan salts 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 chitosan salts.

1.3 As with any material, some characteristics of chitosan 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.

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ASTM F 2900 : 2011 Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020)
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 2260 : 2018 Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (<sup>1</sup>H NMR) Spectroscopy
ASTM F 2602 : 2018 Standard Test Method for Determining the Molar Mass of Chitosan and Chitosan Salts by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)

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