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ISO 14644 vs. FS209E (Part 1)

ISO 14644 vs. FS209E (Part 1)
Massie Ballon

First published in 1963, US Federal Standard 209E, which dealt with cleanroom classification and monitoring, was also used for several years by other nations. The European Committee for Standardization (CEN) worked with the International Organization for Standardization (ISO) to develop standards to be used by all of Europe, though each member nation had their own national standards as well. The need for a single standard for cleanroom classification and testing by which regulatory agencies and (multinational) companies around the world would comply was long felt, but it was never fully realized until 1992, when the American National Standards Institute (ANSI), backed by the Institute of Environmental Sciences and Technology (IEST) petitioned ISO to develop an international standard that would be used on a global scale.

To that end, ISO formed Technical Committee (TC) 209 and began developing standards for cleanroom classification and monitoring that are now known as ISO 14644 and 14698. Seven years later, ISO/TC 209 saw IEST publish ISO 14644-1, the first international standard to deal with cleanliness classifications. ISO 14644-2 was published in 2000 and discussed the monitoring procedures required to remain compliant with ISO 14644-1.

Summary Table: ISO vs. FS209E
Affected Parameters FS209E ISO 14644-1
# Cleanliness Classes 6 9
Class Designations 1 - 10000 1 - 9
Measurements taken in feet meters
Sample time, minutes >1 minute for smaller particle sizes 1 minute minimum for all particles

The most marked differences between FS209E and ISO 14644 are the addition of 3 more cleanliness classes, new class designations, and the use of the metric system in calculating both the minimum volume of air and the dimensions of the test area. In general, fewer sample locations are required when following ISO 14644, though the required minimum sample time of one minute is longer than that for FS209E. Finally, per ISO 14644, the cleanliness classes are now calculated, a standard particle size (1.0┬Ám) has been added, and there are guidelines for establishing periodic testing schedules.

Class Designations
FS209E (English)
ISO 14644-1
-
1
-
2
1
3
10
4
100
5
1000
6
10000
7
100000
8
-
9

European nations declared their own standards superceded by Parts 1 and 2 of ISO 14644 six months after the publication of each document, and the US reached that same conclusion in November 2001 when it declared FS 209E “cancelled and superceded”. However, there are still several companies in the United States that have not yet begun using the now-current standards.


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