Recognized standard
F2102-17
FDA recognition 8-470 · ASTM · Materials
Key facts
| Recognition number | 8-470 |
|---|---|
| Designation | F2102-17 |
| Title | Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Sep 17, 2018 |
| Scope (excerpt) | 1.1 This guide covers a method for the measurement of the relative extent of oxidation present in HDPE homopolymers and ultra-high-molecular-weight polyethylene (UHMWPE) intended for use in medical implants. The material is analyzed by infrared spectroscopy. The intensity (area) of the carbonyl… |
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: