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An update on the ISO & CEN Cleanroom Standards
A look at some of the most significant cleanroom standard updates of late that your facility needs to be aware of. Gordon Farquharson, chair of both BSI LBI/030 and CEN TC243, provides a quick update.
Following a protracted period of slow development, 2021 came to a conclusion with a flurry of cleanroom standards activity, including the beginning of the revision of some established standards and opportunities to comment on and cast votes on work reaching the DIS and FDIS phases.
Many nations continue to make significant contributions to this standardization work, including the UK's British Standards (BSI) committee LBI/030, which functions through and is connected to Committee for European Normalization (CEN) TC 243 and Technical Committee (TC) 209 of the International Standards Organization (ISO).
The chair of both BSI LBI/030 and CEN TC243 is Gordon Farquharson, the author of this work. It's critical to remember that CEN is a Pan-European organization and not the EU in the context of Brexit. As a result, the UK continues to play a significant role in both CEN and ISO.
The EN ISO 14644-4 revision was the most significant recent activity.
The ability to analyze, comment on, and vote on the revision of EN ISO 14644-4 was the most significant very recent activity (Design, Construction & Startup). The present published standard, which was first released in 2001, needs to be updated. UK specialists have been actively participating in the revision process organized by NEN (the Dutch standards organization) over the past three years and have backed the Dutch association for pollution control VCCN. After completing the standard development phases, the work was released for public discussion and DIS voting in November 2021.
In parallel with ISO and CEN, UK experts reviewed the DIS, produced comments and improvement suggestions, and delivered their opinions and vote. We had to decide to return the standard for more development due to the type and scope of the UK complaints.
The working group's endeavor to draught continues to have the full support of the UK. The UK feels a second DIS investigation and vote are necessary and hopes that its comments will be considered. Of course, other countries may vote in a different way, and the outcome of the vote is eagerly watched because part 4 is so crucial to the cleanroom industry.
En ISO 14644-8, 9, and 10 revisions from 2012/13 reached their FDIS enquiry and vote stage in December 2021. To transform them from so-called "classification of cleanliness" standards to "monitoring cleanliness" standards, these standards for air (part 8), surface (part 10), and surface particle cleanliness (part 9) required primarily editorial alteration. This modification was necessary as a result of the realization that EN ISO 14644-1 stipulates the classification of air cleanliness by particle number concentration utilizing a sampling regime with a statistically-based probability of identifying out-of-limit sites. Parts 8, 9, and 10 were not affected by this; as a result, they needed to be revised as monitoring standards.
In November and December 2021, the development or revision of certain more significant standards got under way.
The first stage of the first draught of the new standard BS EN ISO 14644-18, "Assessment of (cleanroom) consumable compatibility," has been completed to CD committee draught stage. Currently, industry has the chance to examine this paper.
National standards bodies have submitted a new work item proposal (NWIP) to create a new microbiological contamination control standard for voting. The task will be to create a new EN ISO standard to replace ISO 14698: parts 1 and 2 and EN 17141:2020 based on the recently released EN 17141:2020. Ultimately, resolutions to begin the systematic review modifications of BS EN ISO 14644: parts 5 and 7 were agreed at the annual plenary meeting of ISO TC209. These are the standards for filtration devices and cleanroom operations, respectively.