Recognized standard
D4169-22
FDA recognition 14-576 · ASTM · Sterility
Key facts
| Recognition number | 14-576 |
|---|---|
| Designation | D4169-22 |
| Title | Standard Practice for Performance Testing of Shipping Containers and Systems |
| Standards developer | ASTM International |
| Specialty area | Sterility |
| Date of entry | May 30, 2022 |
| Scope (excerpt) | 1.1 This practice provides a uniform basis of evaluating, in a laboratory, the ability of shipping units to withstand the distribution environment. This is accomplished by subjecting them to a test plan consisting of a sequence of anticipated hazard elements encountered in various distribution… |
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: