Standard Guide for Characterizing Fiber-Based Constructs for Tissue-Engineered Medical Products

Importancia y uso:

5.1 The test methods contained herein guide characterization of the structural, physical, chemical, mechanical, and biological properties of a fiber-based construct. Such properties may be important for the success of a TEMP, especially if they affect cell retention; activity and organization; tensile strength; the delivery of bioactive agents; or the biocompatibility and bioactivity of the construct.

5.2 Tests described herein may be used for quality control during manufacturing or to assess how the product may perform its intended clinical function.

5.3 Plans for product development, product characterization, and the regulatory pathway should be discussed with the appropriate regulatory body.

Subcomité:

F04.42

Referida por:

F2952-22, F3659-24

Volúmen:

13.02

Número ICS:

11.040.40 (Implants for surgery, prosthetics and orthotics)

Palabras clave:

electrospinning; fiber-based constructs; nonwoven; porosity; scaffold;