Recognized standard
14644-2 Second edition 2015-12-15
FDA recognition 14-481 · ISO · Sterility
Key facts
| Recognition number | 14-481 |
|---|---|
| Designation | 14644-2 Second edition 2015-12-15 |
| Title | Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Jun 27, 2016 |
| Scope (excerpt) | ISO 14644-1:2015 specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones; and separative devices as defined in ISO 14644 7. Only particle populations having cumulative distributions based on threshold (lower limit) particle s… |
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: