Recognized standard
ST55:2016/(R)2023
FDA recognition 14-518 · AAMI · Sterility
Key facts
| Recognition number | 14-518 |
|---|---|
| Designation | ST55:2016/(R)2023 |
| Title | Table-top steam sterilizers |
| Standards developer | Association for the Advancement of Medical Instrumentation |
| Specialty area | Sterility |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard establishes minimum construction and performance requirements for small tabletop steam sterilizers that use saturated steam as the sterilizing agent and that have a volume less than or equal to 56.63 liters (2 cubic feet). |
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: