The Journal of the IEST presents the second in a series of outreach articles by ISO/TC 209 leaders to foster promotion and education of the expanding body of ISO/TC 209 Standards


Within the International Organization for Standardization (ISO), Technical Committee (TC) 209 is chartered with standardization of cleanrooms and associated controlled environments. A series of 15 international standards (thirteen parts under ISO 14644 and ISO 14698 Parts 1–2) has been established for controlling contamination by means of cleanroom technology. The standards address design, classification, and monitoring, and support operation of cleanrooms.

The committee's most recently published standard, ISO 14644-12, Cleanrooms and associated controlled environments—Part 12: Specifications for monitoring air cleanliness by nanoscale particle concentration, provides specifications for the cleanroom monitoring of nanoscale particles (nanoparticles) smaller than 100 nm with a condensation particle counter or equivalent. The standard provides guidance for air monitoring for the purpose of identifying the contributions of sources to the cleanroom burden of particles.

Sources of nanoscale particles are primarily from the processes in the cleanroom. The standard includes example specifications for instrumentation performance and information on how to apply the data. Intended users include process engineers and cleanroom specialists. It is anticipated that as the nanotechnology field advances, this standard may find extensive use.

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About the authors

Anne Marie Dixon-Heathman is managing partner of Cleanroom Management Associates, Inc., a consulting firm that specializes in cleanrooms and controlled environments. She is currently the head of US delegation for ISO TC 209, Cleanrooms and associated controlled environments, and Convenor of Working Group 10, which developed ISO 14644-12. Dixon-Heathman is a Past President and Fellow of IEST

David S. Ensor, Ph.D., retired in 2014 as a Distinguished Research Fellow in aerosol science and nanotechnology from RTI International. Ensor is currently Chairman of ISO/TC 209 and an expert representing the United States to ISO/TC 229, Nanotechnologies. He received the American National Standards Institute 2009 Meritorious Service Award.