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 ISO14644-1 for the designated classification of airborne particulate cleanliness.
The United Kingdom is the convenor the Working Group that produced ISO14644-2. 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.