Recognized standard
14644-4 Second edition 2022-11
FDA recognition 14-589 · ISO · Sterility
Key facts
| Recognition number | 14-589 |
|---|---|
| Designation | 14644-4 Second edition 2022-11 |
| Title | Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Dec 18, 2023 |
| Scope (excerpt) | This document specifies the process for creating a cleanroom from requirements through to its design, construction and start-up. It applies to new, refurbished and modified cleanroom installations. It does not prescribe specific technological or contractual means of achieving these requirements. It… |
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: