Recognized standard
F3004-13 (Reapproved 2020)
FDA recognition 14-549 · ASTM · Sterility
Key facts
| Recognition number | 14-549 |
|---|---|
| Designation | F3004-13 (Reapproved 2020) |
| Title | Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound |
| Standards developer | ASTM International |
| Specialty area | Sterility |
| Date of entry | Jul 6, 2020 |
| Scope (excerpt) | 1.1 This standard method describes the technology and testing procedures that can be used to detect seal defects in the range of 1 mm and characterize seal quality in a variety of packaging styles using airborne ultrasound technology. 1.2 This test method does not purport to be the only method for… |
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: