FDA-recognized standard · Sterility
ISO 14644-1: Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
Yes. FDA recognizes ISO 14644-1 Second edition 2015-12-15 as recognition 14-500, entered 2016-12-23.
Recognized editions of ISO 14644-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 14-500 | ISO 14644-1 Second edition 2015-12-15 | 2016-12-23 | Complete | — |
Product codes that cite ISO 14644-1
No product code cites ISO 14644-1: it is a horizontal standard, applied across device types rather than tied to particular codes.
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.