Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products

Importancia y uso:

4.1 The physico-chemical characteristics of the raw or starting material used in regenerative medicine scaffolds carries significant potential to affect product performance by influencing mechanical properties, chemical reactions, cell behavior, and/or the release of bioactive molecules or drugs. This guide describes recommended specifications or characterizations of raw or starting materials to ensure reproducibility prior to their fabrication into implantable tissue-engineering scaffolds and/or controlled release matrices.

4.2 In all cases, the specifications for any single product should be chosen with primary consideration to that product’s safety and performance requirements and risks. This guide provides typical attributes that will not all be necessary and will not always be sufficient.

Subcomité:

F04.42

Referida por:

F3163-22, F3510-21, F2211-13R21, F3274-21, F2150-19, F3659-24

Volúmen:

13.01

Número ICS:

11.040.40 (Implants for surgery, prothetics and orthotics)

Palabras clave:

biomaterials; ceramics; composites; materials; metals; natural products; polymers; regenerative medicine; tissue-engineered medical products;