ISO 14644-5

ISO 14644-5, Cleanrooms and associate controlled environments - Part 5: Operations, was revised and published as an International Standard in 2025 and is available from IEST. The document was submitted as an American National Standard and has been adopted as ANSI/IEST/ISO 14644-5:2025 in the United States.

This second edition cancels and replaces the first edition (ISO 14644-5:2004), which has been technically revised. The main changes are as follows:

• new normative content for development of an impact assessment, development of an Operations Control Program and the associated programs that support cleanroom operation, and updated information concerning the movement of goods and materials into and out of the cleanrooms;
• informative sections have been condensed so as not to duplicate information available in books and papers.

Background of Document
Cleanrooms provide the basic controlled environment needed by many diverse industries to provide high quality products and services. Cleanrooms are specified and built to satisfy these basic demands to conform with standards specified in ISO 14644, Part 1: Classification of air cleanliness. However, if extraordinary means are not taken to operate and maintain the cleanroom environment during the production operation, then it will deteriorate quickly and the product or process will be compromised.

The scope of Working Group 5 is to provide those basic requirements for operating and maintaining cleanrooms and associated controlled environments to meet the standards of the particular cleanroom as designed, built, and used. This standard addresses requirements that are basic to the operation of all cleanrooms regardless of the application. Required topics include:

• Operational systems that must be in place
• Selection and use of appropriate cleanroom garments
• Training and monitoring of personnel and activities
• Installation and use of equipment
• Requirements for materials used in the cleanroom
• Maintaining the cleanroom environment in a clean, usable condition conforming to design standards.

View list of ISO 14644 Standards

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