New global cleanroom standards hit milestone
Lisa A. Karter
New global cleanroom standards are one step closer to being finished as the International Organization for Standardization`s Working Group 209 (ISO/TC209) recently elevated three more documents to the critical Draft International Standard (DIS) stage.
With DIS status, the TC209 documents — which all focus on cleanroom and associated controlled environments — can now be legally used in commercial trade. Currently, five documents are in the DIS stage. (See Table 1).
“With the creation of ISO 14644-1 and ISO 14644-2, U.S. Federal Standard 209E essentially becomes obsolete,” says Richard Matthews, chairman of ISO/TC209. All cleanliness criteria have become metric-based only. Classes of air cleanliness as we know them in the United States (Class 100, Class 10,000, etc.) have been given new designations. (See Table 3).
Five additional ISO documents are in various levels of development and are scheduled for elevation to DIS status this year and next. As planned, by the end of 1999, all 10 of the originally planned ISO/TC209 documents will have been issued per the schedule established by technical committee (TC) back in October 1993. The TC209 documents were put together by 1,000 volunteers from 34 countries.
Of the 10 documents, only ISO 14644-1 is in the FDIS stage, the last step before it receives full ISO status. According to Matthews, the U.S. Congress has passed a law requiring the government to sunset federal standards where there are equivalent acceptable commercial standards. These new ISO standards meet this criteria, says Matthews.
However, the U.S. General Services Administration will not verify that Federal Standard 209 will be replaced with ISO. “The disposition of Federal Standard 209 will be determined after the publication of the new ISO standards,” says Bruce Geren, specification manager for the General Services Administration (Fort Worth, TX). Federal agencies, universities, and commercial companies will be canvassed to see if they want Federal Standard 209 to be replaced with the ISO documents, says Geren.
Experts predict that the new ISO standards will have a huge impact on the cleanroom industry. “The actions of ISO/TC209 will change the way the cleanroom industry thinks,” says Matthews. “The cleanroom industry will now be able to speak a single universal language. This will make it more convenient for companies to do business across national boundaries.” Most importantly, definitions of clean space will be the same in all parts of the world. However, cautions Matthews, it is up to the various regulatory authorities to adopt their rules and regulations to match these new ISO standards.
The biggest and most direct benefit of the new standards will be the “unification of the cleanroom community around common denominator standards,” says Matthews. “In the long run, this should improve clean space cost/benefits for designers of, users of, and end products made in clean environments.”
In April, a task force will meet to decide if ISO/TC209 should establish standards for molecular contamination. The task force will meet at the next ISO/TC209 meeting being held in conjunction with the 44th IEST Annual Technical Meeting, which takes place April 26 to May 1 in Phoenix, AZ.