Recognized standard
F1877-16
FDA recognition 2-246 · ASTM · Biocompatibility
Key facts
| Recognition number | 2-246 |
|---|---|
| Designation | F1877-16 |
| Title | Standard Practice for Characterization of Particles |
| Standards developer | ASTM International |
| Specialty area | Biocompatibility |
| Date of entry | Aug 21, 2017 |
| Scope (excerpt) | 1.1 This practice covers a series of procedures for characterization of the morphology, number, , and distribution of particles. The methods utilized include sieves, optical, scanning electron microscopy (SEM), transmission electron microscopy (TEM), and electrooptical. 1.2 These methods are… |
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: