ISO 14644-4, Design, construction and start-up
(U.S. Title: ANSI/IEST/ISO 14644-4:2001)


NOTE: The FDIS (Federal Draft International Standard) ballot for ISO 14644-4 was issued in August 2022. Interested parties can purchase this draft in the bookstore. Affected parties are allowed to submit public comments for consideration by the US TAG to ISO/TC 209. All comments must be submitted by October 13, 2022 to

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. This International Standard also provides guidance on the basic elements of design and construction. The document was submitted as an American National Standard and has been adopted as ANSI/IEST/ISO 14644-4:2001 in the United States.

Scope of ISO 14644-4
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.

View list of ISO 14644 Standards