Standard Guide for Characterization and Testing of Alginates 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 alginate. This guide can be used as an aid in the selection and characterization of the appropriate alginate for a particular application. This guide 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 alginate. It may have use in the regulation of these devices by appropriate authorities.

4.2 The alginate covered by this guide may be gelled, extruded, or otherwise formulated into biomedical devices for use in 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. Further guidance for immobilizing or encapsulating living cells or tissue in alginate gels can be found in Guide F2315.

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

Subcomité:

F04.42

Referida por:

F2900-25, F2605-16R25, F2027-25, F2211-13R21, F2259-25, F3274-21, F2315-18, F3659-24

Volúmen:

13.01

Número ICS:

11.040.40 (Implants for surgery, prothetics and orthotics)

Palabras clave:

alginates; biomedically engineered; tissue-engineered medical products;