Recognized standard
D3078-02 (Reapproved 2021)e1
FDA recognition 14-257 · ASTM · Sterility
Key facts
| Recognition number | 14-257 |
|---|---|
| Designation | D3078-02 (Reapproved 2021)e1 |
| Title | Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission |
| Standards developer | ASTM International |
| Specialty area | Sterility |
| Date of entry | Jul 9, 2014 |
| Scope (excerpt) | 1.1 This test method covers the determination of gross leaks in flexible packaging containing a headspace gas. Test sensitivity is limited to 1x10-5 atm cm3/s (1x10-6 Pa m3/s) or even less sensitive as indicated in a recent interlaboratory test (reported in Section 12). 1.2 Small leaks may not be… |
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: