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 environments—Part 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
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
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