FDA-recognized standard · Sterility
ASTM F2096: Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
Yes. FDA recognizes ASTM F2096-11 (Reapproved 2019) as recognition 14-359, entered 2013-01-15.
Recognized editions of ASTM F2096
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 14-359 | ASTM F2096-11 (Reapproved 2019) | 2013-01-15 | Complete | — |
Product codes that cite ASTM F2096
No product code cites ASTM F2096: it is a horizontal standard, applied across device types rather than tied to particular codes.
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.