ISO/TC 209 Standards and Drafts - ISO 14644-4


ISO 14644, Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up, specifies requirements for the design and construction of cleanroom and clean air devices, as well as requirements for start-up and qualification. It also provides guidance on the basic elements of design and construction.

ISO 14644-4 specifies the requirements for the design and construction of the cleanroom facilities (to be referred to as clean installations) but does not prescribe specific technological nor contractual means to meet the requirements. It is intended for use by purchasers, suppliers, and designers of cleanroom installations and provides a check list of important parameters of performance. Construction guidance is provided, including requirements for start up and qualification. Basic elements of design and construction needed to ensure continued satisfactory operations are identified through the consideration of relevant aspects of operation and maintenance.

Limitations include:

  • User requirements are represented by purchaser or specifier.
  • Specific processes to be accommodated in the cleanroom installations are not specified.
  • Fire and safety regulations are not considered specifically; the appropriate national and local requirements should be respected
  • Process media and utility services are only considered with respect to their routing between and in the different zones of cleanliness.
  • Regarding initial operation and maintenance, only cleanroom construction-specific requirements are considered.

Germany (DIN) is the convenor of the Working Group that produced ISO 14644-4. Over 1,000 professionals from the 34 nations of ISO/TC 209 have created a family of true international standards, governing all aspects of the cleanroom community - from design inception to daily operations.