
ISO
ISO 14644 Series: Cleanroom Standards
Standard Overview
ISO 14644 Standards were first formed from the US Federal Standard 209E Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones. As cleanrooms became more sophisticated, the need for wider ranging standards was recognized. The need for a single standard for cleanroom classification and testing was long felt. This lead to the formation of ISO Technical Committee 209. The goal of ISO TC 209 was the "standardization of equipment, facilities, and operational methods for cleanrooms and associated controlled environments."
DOCUMENT | TITLE | STATUS | DESCRIPTION |
---|---|---|---|
ISO 14644-1 | Classification of air cleanliness by particle concentration | ANSI Standard 2015 | Covers the classification of air cleanliness in cleanrooms and associated controlled environments. |
ISO 14644-2 | Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration | ANSI Standard 2015 | Specifies requirements for monitoring and periodic testing of a cleanroom or clean zone to prove its continued compliance with ISO 14644-1. |
ISO 14644-3 | Test methods | ANSI Standard 2005 | Specifies test methods for designated classification of airborne particulate cleanliness for characterizing the performance of cleanrooms and clean zones. |
ISO/DIS 14644-3 | Test methods | DIS December 2016 | This new Draft International Standard updates "textbook" guidance that has been in use since 2005 and sets out appropriate test methods for measuring the performance of an installation, a cleanroom, or an associated controlled environment. |
ISO 14644-4 | Design, construction, and start-up | ANSI Standard 2001 | Specifies requirements for the design and construction of cleanroom installations. |
ISO 14644-5 | Operations | ANSI Standard Aug. 2004 | Specifies basic requirements for cleanroom operations. |
ISO 14644-7 | Separative devices (clean air hoods, gloveboxes, isolators, minienvironments) | ANSI Standard Nov. 2004 | Specifies the minimum requirements for the design, construction, installation, testing and approval of separative devices. |
ISO 14644-8 | Classification of air cleanliness by chemical concentration (ACC) | ANSI Standard 2013 | Covers the classification of airborne molecular contamination (AMC) in cleanrooms and associated controlled environments. |
ISO 14644-9 | Classification of surface particle cleanliness | ANSI Standard 2012 | Establishes the classification of cleanliness levels on solid surfaces by particle concentration in cleanrooms and associated controlled environments. |
ISO 14644-10 | Classification of surface cleanliness by chemical concentrations | Standard 2013 | Defines the classification system for cleanliness of surfaces in cleanrooms with regard to the presence of chemical compounds or elements. |
ISO/DIS 14644-12 | Specifications for monitoring air cleanliness by nanoscale particle concentration | DIS Oct. 2016 | Covers the monitoring of air cleanliness by particles in terms of concentration of airborne nanoscale particles. |
ISO/FDIS 14644-13 | Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications | FDIS Feb. 2017 | Addresses the cleaning to a specified degree on cleanroom surfaces, surfaces of equipment in a cleanroom and surfaces of materials in a cleanroom. |
ISO 14644-14 | Assessment of suitability for use of equipment by airborne particle concentration | Standard 2016 | Specifies a methodology to assess the suitability of equipment for use in cleanrooms and associated controlled environments. |
ISO/DIS 14644-15 | Assessment of suitability for use of equipment and materials by airborne chemical concentration | DIS Apr. 2016 | Provides requirements and guidance for assessing the chemical airborne cleanliness of equipment and materials which are foreseen to be used in cleanrooms and associated controlled environments. |
Products Used in Testing

Beckman Coulter MET ONE 3411
- Cleanroom-friendly monitoring: Reduced particle impact on cleanroom environment
- Unit-to-unit accuracy and reproducibility: Assured through ISO 21501 compliance
- Flexible communications: Wireless, Ethernet, Serial, and USB


Particle Measuring Systems Lasair III Portable Particle Counter Series
- ISO 21501 compliant particle counter with built-in Pulse Height Analyzer (PHA)
- 100 LPM, 50 LPM, or 1 CFM flow rates available - 100 LPM flow samples 1 m3 in 10 minutes
- Large IR touch screen for simplified use


TSI AeroTrak 9110 Portable Particle Counter
- Accurately measures particles at 0.100 μm
- 0.100 to 10.0 μm size range
- Up to eight channels of simultaneous data
