Recognized standard
14644-10 First edition 2013-03-01
FDA recognition 14-390 · ISO · Sterility
Key facts
| Recognition number | 14-390 |
|---|---|
| Designation | 14644-10 First edition 2013-03-01 |
| Title | Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Jan 27, 2015 |
| Scope (excerpt) | ISO 14644-10:2012 defines the classification system for cleanliness of surfaces in cleanrooms with regard to the presence of chemical compounds or elements (including molecules, ions, atoms and particles). It is applicable to all solid surfaces in cleanrooms and associated controlled environments… |
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: