Recognized standard
F1877-24
FDA recognition 2-306 · ASTM · Biocompatibility
Key facts
| Recognition number | 2-306 |
|---|---|
| Designation | F1877-24 |
| Title | Standard Practice for Characterization of Particles |
| Standards developer | ASTM International |
| Specialty area | Biocompatibility |
| Date of entry | May 26, 2025 |
| Scope (excerpt) | 1.1 This practice covers a series of recommendations, generally applicable to all medical devices, for characterization of the morphology, shape, size, and size distribution of particles. The methods utilized include sieves, optical, scanning electron microscopy (SEM), transmission electron… |
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: