Recognized standard
F1925-24
FDA recognition 8-645 · ASTM · Materials
Key facts
| Recognition number | 8-645 |
|---|---|
| Designation | F1925-24 |
| Title | Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Dec 22, 2025 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | 1.1 This specification covers virgin semi-crystalline poly(l-lactide) or poly(d-lactide) homopolymer resins intended for use in surgical implants. This specification also covers semi-crystalline resins of l-lactide copolymerized with other bioabsorbable monomers including, but not limited to… |
At a glance
- 1–9 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: