Recognized standard
F2391-05 (Reapproved 2016)
FDA recognition 14-169 · ASTM · Sterility
Key facts
| Recognition number | 14-169 |
|---|---|
| Designation | F2391-05 (Reapproved 2016) |
| Title | Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas |
| Standards developer | ASTM International |
| Specialty area | Sterility |
| Date of entry | Dec 23, 2016 |
| Scope (excerpt) | 1.1 This test method includes several procedures that can be used for the measurement of overall package and seal barrier performance of a variety of package types and package forms, as well as seal/closure types. The basic elements of this method include: 1.1.1 Helium (employed as tracer gas)… |
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: