Recognized standard

F2042-18

FDA recognition 8-503 · ASTM · Materials

Key facts

Recognition number 8-503
Designation F2042-18
Title Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications - Part II - Crosslinking and Fabrication
Standards developer ASTM International
Specialty area Materials
Date of entry Jul 15, 2019
Scope (excerpt) 1.1 This guide is intended to educate potential users of silicone elastomers, gels and foams relative to their fabrication and processing. It does not provide information relative to silicone powders, fluids, pressure sensitive adhesives, or other types of silicone products. 1.2 The information…

At a glance

  • None Product codes
  • 1–9 FDA guidance documents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA-recognized consensus standards

The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.

Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date:

Browse all FDA-recognized consensus standards