Recognized standard
F2695-12(2020)
FDA recognition 8-573 · ASTM · Materials
Key facts
| Recognition number | 8-573 |
|---|---|
| Designation | F2695-12(2020) |
| Title | Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and 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 specification covers ultra-high molecular weight polyethylene (UHMWPE) powder blended with alpha-tocopherol (Vitamin E) intended for use in surgical implants. 1.2 The requirements of this specification apply to alpha-tocopherol-containing UHMWPE in two forms. One is virgin polymer powder… |
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: