Recognized standard
F2338-09 (Reapproved 2020)
FDA recognition 14-282 · ASTM · Sterility
Key facts
| Recognition number | 14-282 |
|---|---|
| Designation | F2338-09 (Reapproved 2020) |
| Title | Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method |
| Standards developer | ASTM International |
| Specialty area | Sterility |
| Date of entry | Jul 9, 2014 |
| Scope (excerpt) | 1.1 Test Packages-Packages that can be nondestructively evaluated by this test method include: 1.1.1 Rigid and semi-rigid non-lidded trays. 1.1.2 Trays or cups sealed with porous barrier lidding material. 1.1.3 Rigid, nonporous packages. 1.1.4 Flexible, nonporous packages. 1.2 Leaks Detected-This… |
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: