Recognized standard
14644-8 Third edition 2022-06
FDA recognition 14-590 · ISO · Sterility
Key facts
| Recognition number | 14-590 |
|---|---|
| Designation | 14644-8 Third edition 2022-06 |
| Title | Cleanrooms and associated controlled environments - Part 8: Assessment of air cleanliness by chemical concentration (ACC) |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Dec 18, 2023 |
| Scope (excerpt) | This document establishes typical assessment processes to determine grading levels of air chemical cleanliness (ACC) in cleanrooms and associated controlled environments, in terms of airborne concentrations of specific chemical substances (individual, group or category), and provides a protocol to… |
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: