Recognized standard
F3287-17e1
FDA recognition 14-532 · ASTM · Sterility
Key facts
| Recognition number | 14-532 |
|---|---|
| Designation | F3287-17e1 |
| Title | Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method |
| Standards developer | ASTM International |
| Specialty area | Sterility |
| Date of entry | Jul 15, 2019 |
| Scope (excerpt) | 1.1 This method provides a nondestructive means to detect holes (leaks) in a variety of non-porous rigid and semi-rigid packages. 1.2 This test method detects package leaks by measuring the mass flow extracted from a package while the package is enclosed inside an evacuated test chamber. The test… |
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: