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ASTM-F2347 2011

$40.63

F2347-11 Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications

Published By Publication Date Number of Pages
ASTM 2011 10
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1.1 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).

1.2 This guide addresses key parameters relevant to the characterization and purity of hyaluronan.

1.3 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.

1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.5 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.

PDF Catalog

PDF Pages PDF Title
1 Scope
Referenced Documents
2 Terminology
3 Significance and Use
Chemical and Physical Test Methods
4 FIG. 1
FIG. 2
7 Product Development Considerations
Safety and Toxicology Aspects of Hyaluronan
Keywords
8 X1. RATIONALE
X1.1
X2. BACKGROUND
X2.1
X2.2 Raw Materials for Hyaluronan Production
X2.3 Metabolism
X2.4 Functional Properties and Applications of Hyaluro-nan
9 REFERENCES
FIG. X2.1
ASTM-F2347 2011
$40.63