Recognized standard
F2095-07 (Reapproved 2021)
FDA recognition 14-256 · ASTM · Sterility
Key facts
| Recognition number | 14-256 |
|---|---|
| Designation | F2095-07 (Reapproved 2021) |
| Title | Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates |
| Standards developer | ASTM International |
| Specialty area | Sterility |
| Date of entry | Jul 9, 2014 |
| Scope (excerpt) | 1.1 These test methods cover the measurement of leaks in nonporous film, foil, or laminate flexible pouches and foil-sealed trays, which may be empty or enclose solid product. If product is enclosed, seals or surfaces cannot be in contact with water, oils, or other liquid. 1.2 These test methods… |
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: