The revised ISO 14644-1 and -2 cornerstone cleanroom standards have been approved as International Standards, after being reviewed and voted upon by ISO member bodies.
ISO 14644 Standards first came about as they were formed from the US Federal Standard 209E Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones. Soon it became clear that, as cleanrooms became more advanced and complex, wider ranging standards would be necessary. ISO Technical Committee 209 was formed with the goal of achieving “standardization of equipment, facilities, and operational methods for cleanrooms and associated controlled environments.”
ISO 14644-1, the first document in the 14644 series, was published in 1999, and ISO 14644-2 was published the following year. These standards led to FED-STD-209E being canceled. The U.S. General Services Administration (GSA) released a Notice of Cancellation for FED-STD-209E, Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones, in November 2001 and FED-STD-209E was then superseded by ISO 14644-1 and ISO 14644-2.
Revisions of ISO 14644-1 and -2 were released In December 2010 as Draft International Standards. Four years later, a second round of revisions to ISO 14644-1 and -2 was released as Draft International Standards. These revisions provided a clearer classification of air cleanliness in cleanrooms and associated controlled environments exclusively in terms of concentration of airborne particles of a designed size range. Final Draft International Standards of both documents were released in August 2015.
IEST is offering its “Understanding the Changes to ISO 14644-1 and ISO 14644-2” course during the 2015 IEST Fall Conference. Participants can learn about the changes in the revised Standards, how they impact cleanroom operations, and the rationale of the documents. The majority portion of the workshop will cover the requirements of ISO/FDIS 14644-1 (2015): Cleanrooms and associated controlled environments—Part 1: Classification of air cleanliness by particle concentration, and ISO/FDIS 14644-2 (2015): Cleanrooms and associated controlled environments—Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration, in their entirety.
See related articles:
Cleanroom Training http://www.cemag.us/articles/2015/07/cleanroom-training
The Implications of ISO/DIS 14644-1.2 http://www.cemag.us/articles/2015/07/implications-iso-dis-14644-12
UPDATED to include more information from IEST:
ISO 14644-1 specifies classes of air cleanliness for the world’s cleanrooms and controlled environments in terms of the number of particles expressed as a concentration in air volume. To determine the class, a specified testing method is required, which includes selection of sampling locations. A major focus in revising ISO 14644-1 (1999) was development of a refined statistical approach regarding the selection and number of sampling locations. The underlying assumption in the 1999 version held that particle counts follow a similar distribution across the room. The new revision discards the previous assumption in order to allow more accurate sampling where particle counts may vary in a more complex pattern.
Another revision in ISO 14644-1 addresses the issues surrounding ≥ 5 μm particle limits for ISO Class 5 in the sterile products annexes of the EU, PIC/S, and WHO GMPs. An adaptation of the macroparticle descriptor is included in the Standard to accommodate the particle size.
ISO 14644-2 emphasizes the need to consider a monitoring strategy in addition to the execution or evaluation of the classification provisions of ISO 14644-1. The requirements of a monitoring plan are detailed, including additional guidance on risk assessment as part of an informative annex.
The mission of ISO/TC 209 is to develop international standards for cleanrooms and associated controlled environments encompassing standardization of equipment, facilities, and operational methods. The committee defines procedural and operational limits and testing procedures to achieve desired attributes to minimize contamination. IEST serves as the Secretariat for ISO/TC 209 and is also the Administrator for the United States Technical Advisory Group (US TAG) to ISO/TC 209. ISO Standards and IEST Recommended Practices for cleanrooms and controlled environments are available through IEST at www.iest.org.