ISO 14644 Part 2 has been revised as a Draft International Standard (DIS): ISO/DIS 14644-2 (2010), Cleanrooms and controlled environments, Part 2: Specifications for monitoring and periodic testing to prove continued compliance with ISO 14644-1:1999. This document is under review by ISO member bodies for voting and comment by May 2, 2011, for approval for submission as a Final Draft International Standard (FDIS). This page describes the current 1999 Standard as well as the 2010 DIS, both of which may be used as trade reference per agreement between customers and suppliers and are available from IEST.

ISO 14644-2, Cleanrooms and associated controlled environments—Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1, may be ordered directly through IEST. ISO Standard 14644-2 was prepared by ISO Technical Committee 209 (ISO/TC 209) and was issued as an International Standard in 2000. IEST serves as Secretariat for ISO/TC 209, which developed the document as part of a series of documents to serve the needs of the global contamination control community. The document was adopted as ANSI/IEST/ISO 14644-2:2000 in the United States following the cancellation of FED-STD-209.

Introduction to ISO 14644-2
This document provides a mechanism to prove continued compliance with ISO 14644-1 and specifies minimum requirements for testing and monitoring. In any testing plan, consideration should also be given to the particular operational requirements, risk assessment of the installation, and its use.

Cleanrooms and associated controlled environments provide for the control of airborne particulate contamination to levels appropriate for accomplishing contamination-sensitive activities. Products and processes that benefit from the control of airborne contamination include aerospace, microelectronics, pharmaceuticals, medical devices, healthcare, food, and others. Many factors besides airborne particulate cleanliness must be considered in the design, specification, operation, and control of cleanrooms and other controlled environments.

Scope of ISO 14644-2
This part of International Standard ISO 14644 specifies requirements for periodic testing of a cleanroom or clean zone to prove its continued compliance with ISO 14644-1 for the designated classification of airborne particulate cleanliness.

These requirements invoke the test described in ISO 14644-1 for the classification of the cleanroom or clean zone. Additional tests are also specified, to be carried out based on the requirements of this International Standard. Optional tests, to be applied at the user's discretion, are also identified.

This part of ISO 14644 also specifies requirements for the monitoring of a cleanroom or clean zone (installation) to provide evidence of its continued compliance with ISO 14644-1 for the designated classification of airborne particulate cleanliness.

The United Kingdom is the convenor the Working Group that produced ISO 14644-2. Over 1,000 professionals from the 34 nations of ISO/TC 209 have united to create a family of true international standards, governing all aspects of the cleanroom community — from design inception to daily operations.

ISO/DIS 14644-2 (2010), Cleanrooms and associated controlled environments—Part 2: Specifications for monitoring and periodic testing to prove continued compliance with ISO 14644-1:XXXX, may be ordered directly through IEST. This Draft International Standard (DIS) provides a process to prove continued compliance with ISO 14644-1:XXXX and specifies minimum requirements for testing and monitoring. In any testing plan, consideration should also be given to the particular operational requirements, risk assessment of the installation, and its use.

Cleanrooms and associated controlled environments provide for the control of airborne particulate contamination to levels appropriate for accomplishing contamination-sensitive activities. Products and processes that benefit from the control of airborne contamination include aerospace, microelectronics, pharmaceuticals, medical devices, healthcare, food and others. Many factors besides airborne particulate cleanliness should be considered in the design, specification, operation and control of cleanrooms and other controlled environments.

Scope of ISO/DIS 14644-2 (2010 )
This part of ISO 14644 specifies requirements for testing and monitoring of a cleanroom or clean zone to prove its continued compliance with ISO/DIS 14644-1 (2010) for the designated classification of air cleanliness by particle concentration.

These requirements invoke the test described in ISO 14644-1:1999 (currently at the DIS stage, i.e., ISO/DIS 14644-1 (2010) for classification of a cleanroom or clean zone. Additional tests are also specified (see 5.2), to be carried out in accordance with the requirements of this part of ISO 14644.

This part of ISO 14644 also specifies requirements for monitoring of a cleanroom or clean zone to provide evidence of its continued compliance with ISO 14644-1:1999 for the designated classification of airborne particulate cleanliness.

Please note: In addition to the new DIS versions of 14644-2, IEST will continue to sell the 2000 version of the Standard until the new version is adopted as an International Standard (thus replacing the previous Standard). Until then, either the 2000 Standard or the new Draft International Standard can be referenced in a contract. It is up to the customer and supplier to mutually agree on the reference.

View list of ISO 14644 Standards