Recognized standard
F1929-15
FDA recognition 14-484 · ASTM · Sterility
Key facts
| Recognition number | 14-484 |
|---|---|
| Designation | F1929-15 |
| Title | Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
| Standards developer | ASTM International |
| Specialty area | Sterility |
| Date of entry | Jun 27, 2015 |
| Scope (excerpt) | 1.1 This test method defines materials and procedures that will detect and locate a leak equal to or greater than a channel formed by a 50 µm (0.002 in.) wire in package edge seals formed between a transparent material and a porous sheet material. A dye penetrant solution is applied locally to the… |
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: