Recognized standard
F2381-19
FDA recognition 11-366 · ASTM · Orthopedic
Key facts
| Recognition number | 11-366 |
|---|---|
| Designation | F2381-19 |
| Title | Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Jul 6, 2020 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | 1.1 This test method describes the measurement of the number of trans-vinylene groups in ultra-high molecular weight polyethylene (UHMWPE) intended for use in medical implants. The material is analyzed by infrared spectroscopy. 1.2 This test method is based on Guide F2102. 1.3 The applicability of… |
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: