Recognized standard
ST50:2004/(R)2018
FDA recognition 14-293 · ANSI · Sterility
Key facts
| Recognition number | 14-293 |
|---|---|
| Designation | ST50:2004/(R)2018 |
| Title | Dry heat (heated air) sterilizers |
| Standards developer | American National Standards Institute |
| Specialty area | Sterility |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard establishes minimum labeling and performance requirements for dry heat (heated air) sterilizers intended for use in dental and medical offices, laboratories, ambulatory-care clinics, hospitals, and other health care facilities. |
At a glance
- 1–9 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: