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ASTM F 2103 Document Information:
Title
Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue- Engineered Medical Product Applications
ASTM International
Publication Date:
May 10, 2001
Scope:
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).
This guide addresses key parameters relevant for the
functionality, characterization, and purity of chitosan salts.
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.
Warning—Mercury has been designated by EPA and
many state agencies as a hazardous material that can cause central
nervous system, kidney, and liver damage. Mercury, or its vapor,
may be hazardous to health and corrosive to materials. Caution
should be taken when handling mercury and mercury-containing
products. See the applicable product Material Safety Data Sheet
(MSDS) for details and EPA's website
(http://www.epa.gov/mercury/faq.htm)
for additional information. Users should be aware that selling
mercury or mercury-containing products, or both, in your state may
be prohibited by state law.
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.
Keywords:
- biomedical
- chitosan salts
- tissue-engineered medical product applications (TEMPs)
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