Recognized standard
ST8:2013/(R)2018
FDA recognition 14-406 · ANSI · Sterility
Key facts
| Recognition number | 14-406 |
|---|---|
| Designation | ST8:2013/(R)2018 |
| Title | Hospital steam sterilizers |
| Standards developer | American National Standards Institute |
| Specialty area | Sterility |
| Date of entry | Jan 30, 2014 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard covers minimum construction and performance requirements for hospital sterilizers that use saturated steam as the sterilizing agent and have a volume greater than 56.63 liters (2 cubic feet). |
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: