Recognized standard
ST108:2023
FDA recognition 14-597 · AAMI · Sterility
Key facts
| Recognition number | 14-597 |
|---|---|
| Designation | ST108:2023 |
| Title | Water Quality for Processing Medical Devices |
| Standards developer | Association for the Advancement of Medical Instrumentation |
| Specialty area | Sterility |
| Date of entry | Dec 18, 2023 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard covers the selection and maintenance of effective water quality suitable for processing medical devices. It provides guidelines for selecting the water quality necessary for the processing of categories of medical devices and addresses water treatment equipment, water distribution 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: