Recognized standard
14644-10 Second edition 2022-05
FDA recognition 14-591 · ISO · Sterility
Key facts
| Recognition number | 14-591 |
|---|---|
| Designation | 14644-10 Second edition 2022-05 |
| Title | Cleanrooms and associated controlled environments - Part 10: Assessment of surface cleanliness for chemical contamination |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Dec 18, 2023 |
| Scope (excerpt) | This document establishes appropriate testing processes to determine the cleanliness of surfaces in cleanrooms with regard to the presence of chemical compounds or elements (including molecules, ions, atoms and particles). This document is applicable to all solid surfaces in cleanrooms 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: