ASTM F 2347 Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
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ASTM F 2347 Document Information:
Title
Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
ASTM International
Publication Date:
Nov 1, 2003
Scope:
This guide covers the evaluation of hyaluronan 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 to the characterization
and purity of hyaluronan.
As with any material, some characteristics of hyaluronan may be
altered by processing techniques,
such as cross-linking and sterilization, required for the production
of a specific formulation 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.
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
requirements prior to use.
Keywords:
- biomaterials
- biopolymer
- hyaluronan
- polysaccharide
- TEMPs
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