Recognized standard
F2096-11 (Reapproved 2019)
FDA recognition 14-359 · ASTM · Sterility
Key facts
| Recognition number | 14-359 |
|---|---|
| Designation | F2096-11 (Reapproved 2019) |
| Title | Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) |
| Standards developer | ASTM International |
| Specialty area | Sterility |
| Date of entry | Jan 15, 2013 |
| Scope (excerpt) | 1.1 This test method covers the detection of gross leaks in packaging. Method sensitivity is down to 250 μm (0.010 in.) with an 81 % probability (see Section 11). This test method may be used for tray and pouch packages. 1.2 The sensitivity of this test method has not been evaluated for use with… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
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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: