Recognized standard
ST40:2004/(R)2018
FDA recognition 14-294 · ANSI · Sterility
Key facts
| Recognition number | 14-294 |
|---|---|
| Designation | ST40:2004/(R)2018 |
| Title | Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities |
| Standards developer | American National Standards Institute |
| Specialty area | Sterility |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | This recommended practice provides guidelines for dry heat sterilization in health care facilities. It covers functional and physical design criteria for work areas; staff qualifications, education, and other personnel considerations; sterilization processing procedures; installation, care, and… |
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: