Recognized standard
F2848-25
FDA recognition 8-644 · ASTM · Materials
Key facts
| Recognition number | 8-644 |
|---|---|
| Designation | F2848-25 |
| Title | Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Dec 22, 2025 |
| Scope (excerpt) | 1.1 This specification covers ultra-high-molecular-weight polyethylene (UHMWPE) yarns intended for use in medical devices or components of medical devices, such as sutures and ligament fixations. This specification covers natural (non-colored) and pigmented (colored) yarns. 1.2 This standard is… |
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: