Recognized standard
F1608-21
FDA recognition 14-574 · ASTM · Sterility
Key facts
| Recognition number | 14-574 |
|---|---|
| Designation | F1608-21 |
| Title | Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) |
| Standards developer | ASTM International |
| Specialty area | Sterility |
| Date of entry | May 30, 2022 |
| Scope (excerpt) | 1.1 This test method is used to determine the passage of airborne bacteria through porous materials intended for use in packaging sterile medical devices. This test method is designed to test materials under conditions that result in the detectable passage of bacterial spores through the test… |
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: