Recognized standard
F2625-10 (Reapproved 2016)
FDA recognition 8-368 · ASTM · Materials
Key facts
| Recognition number | 8-368 |
|---|---|
| Designation | F2625-10 (Reapproved 2016) |
| Title | Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Dec 23, 2016 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | 1.1 This test method discusses the measurement of the heat of fusion and the melting point of ultra-high-molecular weight polyethylene (UHMWPE), and the subsequent calculation of the percentage of crystallinity. 1.2 This test method can be used for UHMWPE in powder form, consolidated form, finished… |
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: