Recognized standard
F2038-18
FDA recognition 8-502 · ASTM · Materials
Key facts
| Recognition number | 8-502 |
|---|---|
| Designation | F2038-18 |
| Title | Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I - Formulations and Uncured Materials |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Dec 23, 2019 |
| Scope (excerpt) | 1.1 This guide is intended to educate potential users of silicone elastomers, gels, and foams relative to their formulation and use. It does not provide information relative to silicone powders, fluids, or other silicones. The information provided is offered to guide users in the selection of… |
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: