ISO 14644-1:1999 and ISO/FDIS 14644-1:2015

ISO 14644 Part 1 has been revised as a new, Final Draft International Standard (FDIS): ISO/FDIS 14644-1 (2015), Cleanrooms and controlled environments, Part 1: Classification of air cleanliness by particle concentration. This document - which replaces the 2014 DIS - is under review by ISO member bodies for voting and comment by October 27, 2015, for approval as an International Standard. This page describes the current 1999 Standard and the 2015 FDIS, either of which may be used as trade reference per agreement between customers and suppliers and are available from IEST. Purchase the document.

ISO 14644-1, Classification of air cleanliness
(U.S. Title: ANSI/IEST/ISO 14644-1:1999)

ISO 14644-1, Cleanrooms and associated controlled environmentsPart 1: Classification of air cleanliness

The first official internationally approved Standard in the ISO 14644 series, Part 1: Classification of air cleanliness may be ordered directly through IEST. ISO Standard 14644-1 was the first ISO International Standard prepared by ISO Technical Committee 209 (ISO/TC 209). IEST serves as the official Secretariat for ISO/TC 209, which developed the document as part of a series of 11 documents to serve the needs of the global contamination control community. The document was submitted as an American National Standard and adopted as ANSI/IEST/ISO 14644-1:1999 in the United States, following the cancellation of FED-STD-209.

Introduction to ISO 14644-1
ISO 14644-1 is one part of a series of documents, being developed as International Standards, concerned with cleanrooms and associated subjects. Many factors besides airborne particulate cleanliness must be considered in the design, specifications, operations, and control of cleanrooms and other controlled environments. These are covered in some detail in other parts of the International Standards prepared by ISO/TC 209. 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.

Scope of ISO 14644-1
ISO 14644-1 covers the classification of air cleanliness in cleanrooms and associated controlled environments. Classification in accordance with this standard is specified and accomplished exclusively in terms of concentration of airborne particles. Furthermore, the only particle population's consideration for classification purposes are those that have cumulative distributions based on threshold (lower limit) sizes ranging from 0.1 µm to 5 µm.

The United Kingdom is the convenor for the Working Group that produced ISO 14644-1. 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.

ISO/FDIS 14644-1 (2015): Cleanrooms and associated controlled environments —
Part 1: Classification of air cleanliness by particle concentration
(Not yet adopted as an International Standard or American National Standard)

This Final Draft of ISO 14644 establishes the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones; and separative devices as defined in ISO 14644-7:2004.

Only particle populations having cumulative distributions based on threshold (lower limit) particle sizes ranging from 0,1 μm to 5 μm are considered for classification purposes.

The use of light scattering (discrete) airborne particle counters (LSAPC) is the basis for determination of the concentration of  airborne particles, equal to and greater than the specified sizes, at designated sampling locations.

This part of ISO 14644 does not provide for classification of particle populations that are outside the specified lower threshold particle-size range, 0,1 μm to 5 μm. Concentrations of ultrafine particles (particles smaller than 0,1 μm) are addressed in ISO 14644-12:—, which specifies air cleanliness by nano-scale particles, while an M descriptor (see Annex C) may be used to quantify populations of macroparticles (particles larger than 5 μm).

This part of ISO 14644 cannot be used to characterize the physical, chemical, radiological, viable or other nature of airborne particles.

Please note: In addition to the new FDIS version of 14644-1, IEST will continue to sell the 1999 version of the Standard until the new version is adopted as an International Standard (thus replacing the previous Standard). Until then, either the 1999 Standard or the new Final Draft International Standard can be referenced in a contract. It is up to the customer and supplier to mutually agree on the reference.

View list of ISO 14644 Standards

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