ASTM-F2103 › Historical Revision Information
Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
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Scope
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./p>
Keywords
biomedical; chitosan salts; tissue-engineered medical product applications (TEMPS); ICS Number Code 11.100 (Laboratory medicine)
To find similar documents by ASTM Volume:
13.01 (Medical and Surgical Materials and Devices)
To find similar documents by classification:
11.100.99 (Other standards related to laboratory medicine)
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Document Number
ASTM-F2103-01(2007)e1
Revision Level
2001 R07(E1) EDITION
Status
Superseded
Modification Type
Editorially changed
Publication Date
April 1, 2007
Document Type
Guide
Page Count
8 pages
Committee Number
F04.42