Recognized standard
F2579-18
FDA recognition 8-508 · ASTM · Materials
Key facts
| Recognition number | 8-508 |
|---|---|
| Designation | F2579-18 |
| Title | Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Dec 23, 2019 |
| Scope (excerpt) | 1.1 This specification covers virgin amorphous poly(lactide) homopolymer and poly(lactide-co-glycolide) copolymer resins intended for use in surgical implants. The poly(dl-lactide) homopolymers covered by this specification are considered to be amorphous (that is, void of crystallinity) and are… |
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: