ISO 14644-1:2015 specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones; and separative devices as defined in ISO 14644 7. Revised clean room standards incorporate best practices for contamination control. Part 2 specifies requirements for periodic testing of a cleanroom or clean zone to prove its continued compliance with ISO 14644-1 for the designated classification of airborne particulate cleanliness. In December 2010, revisions of ISO 14644-1 and -2 were released as Draft International Standards. NEW ISO 14644 Cleanroom Standards are now available Get your copies today: 14644-1 14644-2.
The clean room class limits according ISO Standard 14644-1. FS209E contains six classes, while the ISO 14644-1 classification system adds two cleaner standards and one dirtier standard (see chart below). Today, in addition to ISO 14644-1 and ISO 14644-2, eight other cleanroom standards documents are being prepared. ISO Technical Committee 209 has brought the standard of ISO 14644-1:1999 revision which they have been working on for a while into an end.
Keeping biopharmaceutical cleanrooms compliant – ISO 14644-1 uses three parameters to classify air cleanliness and supersedes older standards such as Federal Standard 209E MA del Valle. ISO 14644-1 covers the classification of air cleanliness in cleanroom and associated controlled environments exclusively in terms of concentration of airborne particles. Guide to ISO 14644-1 Cleanroom Classifications and FED Standard 209E comparisons.