Recognized standard
ST98:2022
FDA recognition 14-583 · ANSI · Sterility
Key facts
| Recognition number | 14-583 |
|---|---|
| Designation | ST98:2022 |
| Title | Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices |
| Standards developer | American National Standards Institute |
| Specialty area | Sterility |
| Date of entry | Dec 19, 2022 |
| Scope (excerpt) | This standard covers the requirements to validate cleaning processes that are developed by the medical device manufacturer for processing medical devices. This document applies to all medical devices that require cleaning prior to each clinical use of that device. Clinical uses may be in health care… |
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: