Recognized standard
14644-9 Second edition 2022-05
FDA recognition 14-599 · ISO · Sterility
Key facts
| Recognition number | 14-599 |
|---|---|
| Designation | 14644-9 Second edition 2022-05 |
| Title | Cleanrooms and associated controlled environments - Part 9: Assessment of surface cleanliness for particle concentration |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | May 29, 2024 |
| Scope (excerpt) | This document establishes a procedure for the assessment of particle cleanliness levels on solid surfaces in cleanrooms and associated controlled environment applications. Recommendations on testing and measuring methods, as well as information about surface characteristics, are given in Annexes A… |
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: