Recognized standard
F2097-20
FDA recognition 14-553 · ASTM · Sterility
Key facts
| Recognition number | 14-553 |
|---|---|
| Designation | F2097-20 |
| Title | Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
| Standards developer | ASTM International |
| Specialty area | Sterility |
| Date of entry | Dec 21, 2020 |
| Scope (excerpt) | 1.1 This guide provides directions for the design and evaluation of primary flexible packages for medical products. The package materials must be selected appropriately for manufacturing process, end use, and the product being packaged. 1.2 This guide provides a compendium of test methods… |
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: