Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication

Importancia y uso:

4.1 This guide is intended to provide guidance for the specification and selection of fabrication methods for silicones used in medical devices. It also provides guidance relative to testing that might be done to qualify lots of acceptable material, based on desired performance properties.

4.2 Silicone manufacturers supplying material to the medical device industry should readily provide information regarding non-proprietary product formulation to their customers either directly or through the US FDA Master File program.

Subcomité:

F04.11

Referida por:

F1781-21, F2038-18, F0703-18R22, F1441-03R22

Volúmen:

13.01

Número ICS:

11.040.40 (Implants for surgery, prothetics and orthotics)

Palabras clave:

foam; gel; high consistency rubber; liquid silicone rubber; medical device material; moisture cure; peroxide cure; platinum cure; RTV;