Recognized standard
F2565-21
FDA recognition 8-572 · ASTM · Materials
Key facts
| Recognition number | 8-572 |
|---|---|
| Designation | F2565-21 |
| Title | Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | 1.1 This guide covers extensively crosslinked ultra-high molecular weight polyethylene (UHMWPE) materials (fabricated forms) that are produced starting with virgin resin powders and consolidated forms meeting all the requirements of Specification F648. 1.2 This guide does not cover fabricated forms… |
At a glance
- 10–99 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: