: It is often used in conjunction with ISO 14644-1 , which focuses on the actual classification of air cleanliness by particle concentration.
While ISO 14644-1 defines what "clean" means in terms of particle concentration, Part 3 describes how to measure it and other critical performance parameters. Its scope encompasses various testing methods for both unidirectional and non-unidirectional airflow systems. These tests are typically conducted across three occupancy states:
Compliance with ISO 14644-3 is critical for industries such as , semiconductors , and medical devices . Failure to validate filters or airflow can lead to fungal/bacterial outbreaks, product recalls, and severe regulatory penalties, such as FDA warning letters .
The ISO 14644 series of standards provides guidance on the design, construction, operation, and monitoring of cleanrooms and associated controlled environments. The standard focuses on controlling contamination in terms of airborne particulate, chemical, and microbiological contamination.