Standard Guide for Characterization and Testing of Porcine Fibrinogen as a Starting Material for Use in Biomedical and Tissue-Engineered Medical Product Applications

Importancia y uso:

5.1 The purpose of this guide is to provide guidance on characterization of the properties of porcine fibrinogen as a starting material for surgical implants and as a matrix for tissue-engineered medical products (TEMPs). This guide contains a set of physical and chemical parameters directly related to the function of porcine fibrinogen. This guide can be used to help select and characterize appropriate fibrinogen starting materials for specific purposes. Not all tests or parameters are suitable for all uses of fibrinogen.

5.2 Fibrinogen described in this guide may be used in various types of medical products including, but not limited to, implants, tissue-engineered medical products (TEMPs), and cell, drug, or DNA delivery vectors. The recommendations in this guide shall not be construed to guarantee the successful clinical application of any tissue-engineered medical product.

5.3 In determining whether fibrinogen meets the requirements for use in a TEMP, the relevant regulatory authorities or other appropriate guidelines relating to the production, regulation, and approval of TEMP products shall be taken into account (Guide E1298, Practice F981, Practice F1983).

Subcomité:

F04.42

Referida por:

F3659-24

Volúmen:

13.02

Número ICS:

11.100.20 (Biological evaluation of medical devices)

Palabras clave:

biomaterials; blood clotting; extracellular matrix; fibrin; fibrinogen; natural materials; raw materials; soft tissue; tissue engineered medical products (TEMPs);