Recognized standard
14644-5 First edition 2004-08-15
FDA recognition 14-165 · ISO · Sterility
Key facts
| Recognition number | 14-165 |
|---|---|
| Designation | 14644-5 First edition 2004-08-15 |
| Title | Cleanrooms and associated controlled environments - Part 5: Operations |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Jan 27, 2015 |
| Scope (excerpt) | ISO 14644-5:2004 specifies basic requirements for cleanroom operations. It is intended for those planning to use and operate a cleanroom. Aspects of safety that have no direct bearing on contamination control are not considered in this part of ISO 14644 and national and local safety regulations must… |
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: