Overview and History of ISO 14644 Standards

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."



The first document of the ISO 14644 series was published in 1999 (ISO 14644-1). In 2000, ISO 14644-2 was published, which began the process of 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Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones, on November 29, 2001 and FED-STD-209E was then superseded by ISO 14644-1 and ISO 14644-2.

In December 2010, revisions of ISO 14644-1 and -2 were released as Draft International Standards. In September 2014, a second edition of revisions to ISO 14644-1 and -2 were released as Draft International Standards. The second round of Draft International Standards addressed and incorporated changes based on more than 250 comments received by ISO/TC 209 WG 1 during the initial DIS voting period in 2010. The revised DIS standards, balloted in 2014, better defined classification of air cleanliness in cleanrooms and associated controlled environments exclusively in terms of concentration of airborne particles of a designed size range. These documents were both approved in the second DIS stage, with far fewer technical comments than the previously balloted versions. Final Draft International Standards of both documents were release in August 2015 and were approved as International Standards on October 27, 2015. The standards adopted as identical national standards in the United States (ANS/IEST/ISO Standards) and are now available for purchase through IEST.


ISO 14644 Series Cleanroom Standards
List of ISO 14644 Cleanroom Standards published.

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/DIS 14644-13
Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications DIS Feb. 2016 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.












































 









 



ISO 14644 American National Standards Handbook

The ISO 14644 American National Standards Handbook is available for purchase below. This is the complete series of the American National Standards editions of ISO 14644 Standards. (ISO 14644-10. ISO/DIS 14644-12, ISO/DIS 14644-13, ISO14644-14, ISO/DIS 14644-15 are not included in the Handbook and may be purchased separately.) The ISO 14644 Handbook can be purchased by itself or with related IEST Technical Guides.

IEST members receive substantial discounts on the ISO Handbook. Join IEST