Recognized standard
F2638-22
FDA recognition 14-581 · ASTM · Sterility
Key facts
| Recognition number | 14-581 |
|---|---|
| Designation | F2638-22 |
| Title | Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier |
| Standards developer | ASTM International |
| Specialty area | Sterility |
| Date of entry | Dec 19, 2022 |
| Scope (excerpt) | 1.1 This test method measures the aerosol filtration performance of porous packaging materials by creating a defined aerosol of 1.0 micron particles and assessing the filtration efficiency of the material using either single or dual particle counters. 1.2 This test method is applicable to porous… |
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: