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

Importancia y uso:

4.1 This guide contains a listing of those characterization parameters that are directly related to the functionality of chitosan. This guide can be used as an aid in the selection and characterization of the appropriate chitosan or chitosan salt for a particular application. This standard is intended to give guidance in the methods and types of testing necessary to properly characterize, assess, and ensure consistency in the performance of a particular chitosan. It may have use in the regulation of devices containing chitosan by appropriate authorities.

4.2 The chitosan salts covered by this guide may be gelled, extruded, or otherwise formulated into biomedical devices for use as tissue-engineered medical products or drug delivery devices for implantation as determined to be appropriate, based on supporting biocompatibility and physical test data. Recommendations in this guide should not be interpreted as a guarantee of clinical success in any tissue-engineered medical product or drug delivery application.

4.3 To ensure that the material supplied satisfies requirements for use in TEMPs, several general areas of characterization should be considered. These include identity of chitosan, physical and chemical characterization and testing, impurities profile, and performance-related tests.

Subcomité:

F04.42

Referida por:

F2900-25, F2027-25, F2211-13R21, F2260-18R25, F2602-18R25, F3659-24

Volúmen:

13.01

Número ICS:

11.100 (Laboratory medicine), 11.100.99 (Other standards related to laboratory medicine)

Palabras clave:

biomedical; chitosan salts; tissue-engineered medical product applications (TEMPs);