Recognized standard
14644-7 First edition 2004-10-01
FDA recognition 14-166 · ISO · Sterility
Key facts
| Recognition number | 14-166 |
|---|---|
| Designation | 14644-7 First edition 2004-10-01 |
| Title | Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Jan 27, 2015 |
| Scope (excerpt) | ISO 14644-7:2004 specifies the minimum requirements for the design, construction, installation, test and approval of separative devices, in those respects where they differ from cleanrooms as described in ISO 14644-4 and 14644-5. The application of ISO 14644-7:2004 takes into account the following… |
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: