ISO 14644-4, Design, construction and start-up
(U.S. Title: ANSI/IEST/ISO 14644-4:2022)


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

This document specifies the process for creating a cleanroom from requirements through to its design, construction and start-up. It applies to new, refurbished and modified cleanroom installations. It does not prescribe specific technological or contractual means of achieving these requirements. It is intended for use by users, specifiers, designers, purchasers, suppliers, builders and performance verifiers of cleanroom installations. The primary cleanliness consideration is airborne particle concentration. Detailed checklists are provided for the requirements, design, construction and start-up, which include important performance parameters to be considered. Energy management design approaches are identified to support an energy-efficient cleanroom design. Construction guidance is provided, including requirements for start-up and verification. A basic element of this document is consideration of aspects, including maintenance, that will help to ensure continued satisfactory operation for the entire life cycle of the cleanroom.

NOTE       Further guidance is given in Annexes A to D. ISO 14644-1, ISO 14644-2, ISO 14644-8, ISO 14644-9, ISO 14644-10, ISO 14644-12 and ISO 14644-17 provide complementary information. ISO 14644-7 offers guidance on design, construction and requirements for separative devices (clean air hoods, glove boxes, isolators and mini-environments).

The following subjects are mentioned but not addressed in this document:

    specific operational activities, processes to be accommodated and process equipment in the cleanroom installation;

    fire and safety regulations;

    ongoing operation, cleaning and maintenance activities, which are covered by ISO 14644-5.

View list of ISO 14644 Standards