Recognized standard
M98795_02_01
FDA recognition 14-566 · USP-NF · Sterility
Key facts
| Recognition number | 14-566 |
|---|---|
| Designation | M98795_02_01 |
| Title | <55> Biological Indicators -- Resistance Performance Tests |
| Standards developer | United States Pharmacopeia (USP) and the National Formulary (NF) |
| Specialty area | Sterility |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 2 |
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: