Recognized standard
F1886/F1886M-16
FDA recognition 14-501 · ASTM · Sterility
Key facts
| Recognition number | 14-501 |
|---|---|
| Designation | F1886/F1886M-16 |
| Title | Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection |
| Standards developer | ASTM International |
| Specialty area | Sterility |
| Date of entry | Aug 21, 2017 |
| Scope (excerpt) | 1.1 This test method covers the determination of channels in the package seal down to a width of 75 μm [0.003 in.] with a 60-100 % probability (see Section 8). 1.1.1 The ability to visually detect channel defects in package seals is highly dependent on the of channel, the degree of contrast from… |
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: