Recognized standard
ST91:2021
FDA recognition 14-572 · ANSI · Sterility
Key facts
| Recognition number | 14-572 |
|---|---|
| Designation | ST91:2021 |
| Title | Flexible and semi-rigid endoscope processing in health care facilities |
| Standards developer | American National Standards Institute |
| Specialty area | Sterility |
| Date of entry | May 30, 2022 |
| Scope (excerpt) | Provides guidelines for point of use treatment, transporting, leak testing (where indicated), cleaning, packaging (where indicated), high-level disinfecting and/or sterilizing, storage, and quality control procedures of flexible gastrointestinal (GI) endoscopes, flexible bronchoscopes, flexible ear… |
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: