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ASTM F2103-01(2007)e1

Historical Revision

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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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>

SDO ASTM: ASTM International
Document Number F2103
Publication Date Feb. 1, 2007
Language en - English
Page Count 8
Revision Level 01(2007)e1
Supercedes
Committee F04.42
Publish Date Document Id Type View
June 1, 2018 F2103-18 Revision
March 1, 2011 F2103-11 Revision
Feb. 1, 2007 F2103-01R07E02 Revision
Feb. 1, 2007 F2103-01R07E01 Revision
May 10, 2001 F2103-01 Revision
Feb. 1, 2007 F2103-01R07 Reaffirmation