Recognized standard
14644-3 First edition 2005-12-15
FDA recognition 14-242 · ISO · Sterility
Key facts
| Recognition number | 14-242 |
|---|---|
| Designation | 14644-3 First edition 2005-12-15 |
| Title | Cleanrooms and associated controlled environments - Part 3: Test methods |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Jan 27, 2015 |
| Scope (excerpt) | ISO 14644-3:2005 specifies test methods for designated classification of airborne particulate cleanliness and for characterizing the performance of cleanrooms and clean zones. Performance tests are specified for two types of cleanrooms and clean zones: those with unidirectional flow and those with… |
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: