Recognized standard
ST41:2008/(R)2018
FDA recognition 14-275 · ANSI · Sterility
Key facts
| Recognition number | 14-275 |
|---|---|
| Designation | ST41:2008/(R)2018 |
| Title | Ethylene oxide sterilization in health care facilities: Safety and effectiveness |
| Standards developer | American National Standards Institute |
| Specialty area | Sterility |
| Date of entry | Sep 17, 2018 |
| Scope (excerpt) | This recommended practice covers the safe and effective use of ethylene oxide as a sterilant in health care facilities. The provisions of this document are intended to promote sterility assurance, help minimize occupational exposure to ethylene oxide, and guide health care personnel in the proper… |
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: