New ISO cleanrooms standards may replace existing Fed-Std-209E
By John Haystead
Editor`s Note:This is the first of a two-part series.
Mount Prospect, IL — Decision time is rapidly approaching for the cleanroom industry on the standards and specifications that will carry it into the next millennium. Technical Committee 209 of the International Organization for Standardization (ISO/TC209) is now close to completing its work on a new set of international cleanroom standards, which means the industry will soon have to come to terms with what to do with the existing U.S. Federal Standard 209E (Fed-Std-209E).
ISO/TC209 has brought the first and primary document (14644-1 — “Classification of Air Cleanliness”) to the Final Draft International Standard (FDIS) stage (CleanRooms, February, 1998, p. 1). As described by Richard Matthews, technical committee chairman, the document written by ISO/TC209 Working Group 1 is “now 99 percent complete from a technical standpoint*, subject only to a final-acceptance vote by the ISO member nations, and is expected to be formally published later this year.”
In fact, the ISO/TC209 is developing a total of ten ISO/TC209 documents, four others of which have also already reached the preliminary DIS stage. Although these documents are still being reviewed for comment by member nations, once a document reaches the DIS level, it is, in fact, already qualified for use in commercial trade. Matthews expects several of these documents to also be formally approved this year with four of the remaining five documents beginning their initial DIS review as well. The final document is scheduled for DIS release in February of 1999. An eleventh standards document addressing molecular-level contamination is also being considered.
Show me the standards
Overall, the ISO/TC209 initiative appears to be largely taking the industry unaware, with many senior observers expressing surprise at the imminent publication of documents as well as confusion and uncertainty over whether, or how quickly, the new standards will impact Fed-Std-209E. Although in Europe, new ISO standards automatically supersede any existing national standards, this is not the case in the U.S. where the situation is more complex.
Unlike most European nations, where the ISO regulatory body is also a government standards agency, in the U.S., the responsible organization for ISO standards is the American National Standards Institute (ANSI), an independent, non-governmental body. Fed-Std-209E, on the other hand, falls under the purview of the General Services Administration (GSA; Fort Worth, TX).
The situation becomes even more tangled, however, since the Institute of Environmental Sciences and Technology (IEST) is both the authorized ANSI agent for developing ISO/TC209 and the responsible organization to GSA for the technical-content preparation of the Fed-Std-209 standard. The GSA is ultimately responsible for making the decision whether ISO/TC209 documents (in particular 14644-1) will replace Fed-Std-209E, exist in addition to it, or whether Fed-Std-209E should be rewritten to conform to the ISO standard.
So far the GSA has said it won`t make a determination until the ISO standards are formally published. Bruce Geren, GSA specification manager, says “Although there`s no reason to anticipate that work on ISO/TC209 will stop for any reason, until the documents are published, we don`t officially know how close the two documents will be to each other and therefore can`t determine whether Fed-Std-209E should be retained.” Geren adds, however, that any recommendation made by the IEST will be taken into “major consideration” until the user organizations have had an opportunity to use the new standard. “If the IEST recommends the replacement of Fed-Std-209E with ISO/TC209 standards, we will send out a coordination letter to the users to see if they have any problems before making a final determination.”
Where stands the IEST?
Ultimately then, the common denominator is the IEST, with the big question being what the IEST will recommend to GSA regarding Fed-Std-209E. Matthews, for one, is unequivocal in advocating its elimination. “Once the first two documents are out, we should immediately get rid of 209E which at that point will just be a regulatory headache for everyone involved. With ISO/TC209 in place, Fed-Std-209E will simply be duplicatory, and multinational companies will instead be designing and building to ISO documents.”
According to Bob Spector, IEST technical vice president of the Contamination Control Division, the earliest that any decision could be made will be at the next IEST Technical Meeting scheduled for April in Phoenix, AZ. At that time IEST Working Group 100 (Fed-Std-209E, chaired by David Swinehart) will convene to initially discuss the question. Ultimately, however, “The jury will probably remain out on a final decision until such time as the ISO/TC209 documents are published and have received widespread exposure,” Spector says.
To put the issue in perspective, Spector observes that “most people don`t yet really understand what ISO/TC209 is all about, making it more confusing and complex than it probably should be.” One concern raised by some within the IEST is that the ISO standards will not only impact Fed-Std-209E but the IEST`s “Recommended Practices” documents as well. This is a particularly sensitive issue since the IEST is also currently in the process of applying for ANSI accreditation as an official standards-writing organization. Matthews, however, says these concerns are unwarranted. “IEST`s Recommended Practices will continue to be important, if not more so, reinforcing the ISO standards and taking over where they leave off, particularly for industry-specific needs.”
Throughout the industry, there has also been confusion over a perceived relationship between the use of ISO standards and “ISO 9000” certification. “These are two completely different things,” emphasizes Spector, and as Bob Mielke, secretary to ISO/TC209 and previous chairman of the IEST`s Standards & Practices Committee explains, “People have been using voluntary ISO standards long before there was an ISO 9000 initiative and there is absolutely no requirement for a company to be ISO 9000 accredited in order to use ISO standards. For all practical purposes the test costs are the same or possibly even less for ISO standards.” Mielke does acknowledge, however, that 14644-2 may drive costs up somewhat for some companies, since it requires more frequent testing. Still, as an overall observation, Mielke says that “More than likely, if you meet Fed-Std-209E requirements, you will meet the ISO/TC209`s 14644-1 standard as well.”
Isn`t it already the law?
Another document playing a role in the future of Fed-Std-209E is the National Technology Transfer and Advancement Act (Public Law 104113), which Congress enacted to encourage the government to eliminate federal standards whenever there are equivalent acceptable commercial standards. “The intent of this legislation,” says Matthews, “is to eliminate additional cost burdens placed on U.S. industry to comply with excessive and duplicate sets of government standards. Fed-Std-209E will certainly fall into this category.”
According to Jane Schweiker, ANSI director of public policy and government relations, however, “although the act encourages agencies to rely on and adopt public-sector standards, the law does not specifically require that existing standards be replaced.” Still, Schweiker adds that “the GSA`s record so far has been to work hard to cooperate with the private sector in most areas toward transitioning to public standards.” CR