Recognized standard
F2003-02(2022)
FDA recognition 8-597 · ASTM · Materials
Key facts
| Recognition number | 8-597 |
|---|---|
| Designation | F2003-02(2022) |
| Title | Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | May 29, 2023 |
| Scope (excerpt) | 1.1 It is the intent of this practice to permit an investigator to evaluate the oxidative stability of UHMWPE materials as a function of processing and sterilization method. This practice describes a laboratory procedure for accelerated aging of ultra-high molecular weight polyethylene (UHMWPE)… |
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: