Recognized standard
F561-19
FDA recognition 8-504 · ASTM · Materials
Key facts
| Recognition number | 8-504 |
|---|---|
| Designation | F561-19 |
| Title | Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Jul 15, 2019 |
| Scope (excerpt) | 1.1 This practice covers recommendations for the retrieval, handling, and analysis of implanted medical devices and associated specimens that are removed from human and animal subjects during revision surgery and at postmortem. This practice may be used for the analysis of any implant including… |
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: