Recognized standard
F2459-18
FDA recognition 8-468 · ASTM · Materials
Key facts
| Recognition number | 8-468 |
|---|---|
| Designation | F2459-18 |
| Title | Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Sep 17, 2018 |
| Scope (excerpt) | 1.1 This test method covers the quantitative assessment of the amount of residue obtained from metallic medical components when extracted with aqueous or organic solvents. 1.2 This test method does not advocate an acceptable level of cleanliness. It identifies two techniques to quantify extractable… |
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: