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Frequently Asked Question - Cleanroom Section
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International
cleanroom standards: the first steps
The first step towards international harmonisation of standards
in the field of contamination control technology took place in
1990: the establishment of the European Technical Committee CEN/TC
243: Cleanroom Technology. Its dynamic style and the speedy
progress of work was recognised throughout the contamination control
world, and soon paved the way for a proposal by the United
States of America to upgrade these efforts
to a truly international level.
Thus, the International Technical Committee ISO/TC 209: Cleanrooms
and associated controlled environments was launched in 1993
- a mere three years after CEN/TC 243 had been created. Without
much delay, a common approach to cleanroom technology standardization
was agreed between ISO and CEN. As a consequence, the CEN activities
were fully integrated into the ISO effort, so that the parallel
approval procedures as established by the Vienna Agreement apply.
This gives tremendous weight to the standards thus approved, as
the inclusion into 20 national collections of standards is guaranteed
right from the beginning. No better point of departure for broad
international recognition can be imagined.
Scope and guidance principles for work
The ISO cleanroom standards are intended to cover all relevant aspects
of contamination and biocontamination control technology.
For their development, the following general guidance principles
have been agreed:
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The series of standards to be developed shall address only
subjects of general applicability to all cleanroom usage areas.
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Application-specific standardisation remains outside the
brief of ISO/TC 209.
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The standards to be prepared should be target oriented and
establish objectives to be met.
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As much freedom as possible should be granted regarding the
path leading to the goal.
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The standards should promote and encourage progress, rather
than impeding it.
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The standards should contribute to the elimination of technical
barriers to trade, and promote understanding between nations.
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The standards should neither favour nor prejudice individual
nations.
Target orientation ensures maximum freedom regarding the path
how the target is reached, providing an automatic incentive for
technical progress.
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