Recognized standard
14644-3 Second edition 2020-06
FDA recognition 14-598 · ISO · Sterility
Key facts
| Recognition number | 14-598 |
|---|---|
| Designation | 14644-3 Second edition 2020-06 |
| Title | Cleanrooms and associated controlled environments - Part 3: Test methods |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | May 29, 2024 |
| Scope (excerpt) | This document provides test methods in support of the operation for cleanrooms and clean zones to meet air cleanliness classification, other cleanliness attributes and related controlled conditions. Performance tests are specified for two types of cleanrooms and clean zones: 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: