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ASTM International - ASTM F2347-03

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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Organization: ASTM International
Publication Date: 1 November 2003
Status: inactive
Page Count: 9
ICS Code (Other standards related to pharmaceutics): 11.120.99
significance And Use:

This guide contains a listing of those characterization parameters that are directly related to the functionality of hyaluronan. This guide can be used as an aid in the selection and... View More

scope:

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 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.

Document History

December 1, 2015
Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
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)....
March 1, 2011
Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
This guide contains a listing of those characterization parameters that are directly related to the functionality of hyaluronan. This guide can be used as an aid in the selection and characterization...
ASTM F2347-03
November 1, 2003
Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
This guide contains a listing of those characterization parameters that are directly related to the functionality of hyaluronan. This guide can be used as an aid in the selection and characterization...
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