Recognized standard
14644-9 First edition 2012-08-15
FDA recognition 14-389 · ISO · Sterility
Key facts
| Recognition number | 14-389 |
|---|---|
| Designation | 14644-9 First edition 2012-08-15 |
| Title | Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Jan 27, 2015 |
| Scope (excerpt) | ISO 14644-9:2012 establishes the classification of cleanliness levels on solid surfaces by particle concentration in cleanrooms and associated controlled environment applications. Recommendations on testing and measuring methods, as well as information about surface characteristics are also given… |
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: