ISO/DIS 14644-12

ISO/DIS 14644-12, Classification of air cleanliness by nanoscale particle concentration

ISO/DIS 14644, Cleanrooms and associated controlled environments - Part 12: Classification of air cleanliness by nanoscale particle concentration, is the first of the ISO/TC 209 documents to address the requirements of nanotechnology.

Scope of ISO/DIS 14644-12
This part of ISO 14644 covers the classification of air cleanliness by particles (ACP) in terms of concentration of airborne nanoscale particles. For classification purposes, only populations of particles with a lower size limit of 0.1 microns (100 nm) or less - "nanoscale" - are considered. The classification given in this document is for use mainly in "in operation" states. This classification extrapolates the particulate classification equation specified in 14644-1 into the nanoscale (< 100 nm) region.

Also available: IEST-RP-NANO200 Planning of Nanoscale Science and Technology Facilities

Background of ISO/TC 209 Working Group 10 Nanotechnology
The ISO nanotechnology series was proposed to take a similar path to the ISO 14644 series of cleanroom Standards, but expand the classification range. In both ISO 14644-1 Cleanrooms and associated controlled environments—Part 1: Classification of air cleanliness by particle concentration and ISO 14644-3 Cleanrooms and associated controlled environments—Part 3: Test methods, the normative requirements were limited to classification of particles greater than 0.1 micrometers (100 nanometers). At the time the ISO 14644 documents were written, particles smaller than 100 nm were called “ultrafine particles” rather than the more recent term “nanoparticles.” Although informative material is included in both ISO 14644-1 and -3 for airborne particles smaller than 100 nm, the material will now be removed from the ISO 14644 Standards to take center stage in the new series. For measurement purposes, the only important particle characteristic is its equivalent diameter. In the proposed Standard series, nanoparticle signifies any object with one, two, or three dimensions in the nanoscale.

Cleanrooms and associated controlled environments provide the control of contamination to levels appropriate for accomplishing contamination-sensitive activities. Products and processes that benefit from the control of contamination include those in such industries as aerospace, electronics, pharmaceuticals, medical devices, healthcare, and food. Nanotechnologies are a more recently organized but rapidly growing sector of contamination control, typically dealing with material in the size range of 1 nm to 100 nm. A growing number of manufacturing and research environments, such as those for microelectronics and health-related products, will benefit from the classification requirements of the new series. The new series from ISO/TC 209 will also include supporting information developed by other ISO technical committees such as ISO/TC 229 Nanotechnologies.

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