ISO made some changes by renewing the standard, which was first published in 2001, at the end of last month.
The main changes in the new version are as follows:1. The normative content has been expanded;
2. Added the process of collecting and defining requirements;
3. Expanded coverage from classified cleanrooms to include additional cleaning qualifications;
4. All text has been refreshed or clarified to aid practice.
ISO 14644-4, which is an essential standard for medical device manufacturers who produce in clean rooms and want to establish new clean rooms, contains important conditions that can be used during the design, construction and commissioning of clean rooms, especially in its annexes. The checklists in annexes A, B, C, D can be easily used by manufacturers to complete clean room inspections.