Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials

Importancia y uso:

4.1 This guide is intended to provide guidance for the specification and selection of silicone materials for medical device applications.

4.2 Silicone manufacturers supplying materials 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, F2042-18, F0703-18R22, F1441-03R22

Volúmen:

13.01

Número ICS:

11.040.40 (Implants for surgery, prothetics and orthotics)

Palabras clave:

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