Recognized standard
F3306-19
FDA recognition 8-518 · ASTM · Materials
Key facts
| Recognition number | 8-518 |
|---|---|
| Designation | F3306-19 |
| Title | Standard Test Method for Ion Release Evaluation of Medical Implants |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Jul 15, 2019 |
| Scope (excerpt) | 1.1 This test method assesses metal or other ions released from single-use, metallic, implantable medical devices, or components thereof, by exposing the device to solutions simulating the in-vivo environment and temperature in a container for a predetermined time frame with regular sampling at… |
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: