Recognized standard
F2227-13 (Reapproved 2021)
FDA recognition 14-433 · ASTM · Sterility
Key facts
| Recognition number | 14-433 |
|---|---|
| Designation | F2227-13 (Reapproved 2021) |
| Title | Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO2 Tracer Gas Method |
| Standards developer | ASTM International |
| Specialty area | Sterility |
| Date of entry | Jul 9, 2014 |
| Scope (excerpt) | 1.1 This non-destructive test method detects pinhole leaks in trays, as small as 50 μm (0.002 in.) in diameter, or equivalently d cracks, subject to trace gas concentration in the tray, tray design and manufacturing tolerances. |
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: