Recognized standard
F3039-15
FDA recognition 14-516 · ASTM · Sterility
Key facts
| Recognition number | 14-516 |
|---|---|
| Designation | F3039-15 |
| Title | Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration |
| Standards developer | ASTM International |
| Specialty area | Sterility |
| Date of entry | Sep 17, 2018 |
| Scope (excerpt) | 1.1 Method A of this test method defines a procedure that will detect and locate a leak equal to or greater than a channel formed by a 50 µm [0.002 in.] wire in the edge seals of a nonporous package. A dye penetrant solution is applied locally to the seal edge to be tested for leaks. After contact… |
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: