Recognized standard
F2848-21
FDA recognition 8-578 · ASTM · Materials
Key facts
| Recognition number | 8-578 |
|---|---|
| Designation | F2848-21 |
| Title | Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Dec 20, 2021 |
| 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 (noncolored) 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: