ISO/TC209 Sets Global Cleanroom Standards
The push for global cleanroom standards is a rush for numbers. The world wants a common denominator by which to judge the quality of clean specialized environments.
By Richard A. Matthews
Currently, thirty-three countries are active in the International Organization for Standardization`s Working Group 209 (ISO/TC209) “Cleanrooms and Associated Controlled Environments.” These include the following voting member countries (“P” nations): Australia, Belgium, China, Denmark, Finland, France, Germany, Italy, Jamaica, Japan, Korea, The Netherlands, Norway, Russia, Sweden, Switzerland, United Kingdom and the United States. Other nations (non-voting, or “O” members) are: Bulgaria, Canada, Czech Republic, Egypt, India, Ireland, Malaysia, New Zealand, Poland, Saudi Arabia, South Africa, Thailand, Turkey, Ukraine, and Yugoslavia.
In the past 29 months, ISO/TC209 has met formally four times and has three more meetings scheduled over the next 19 months (September 1996 at The Hague, Netherlands; September 1997 in Seoul, Korea; and April 1998 in Phoenix, AZ). The group has formed itself into seven very active Working Groups (WG):
WG-1: Classes of Air Cleanliness (Convenor–UK)
WG-2: Biocontamination (Convenor–France)
WG-3: Metrology and Testing Methods (Convenor–Japan)
WG-4: Design and Construction (Convenor–Germany)
WG-5: Cleanroom Operations (Convenor–USA)
WG-6: Terms, Definitions, and Units (Convenor–Switzerland)
WG-7: Minienvironments and Isolators (Convenor–USA)
Each Working Group is supported by national standards committees, called in the United States, “Expert Councils,” comprised of 6 to 20 members. Working Groups and Expert Councils meet independently of the full ISO/TC209 Technical Committee for the purpose of harmonizing the various national stan dards from each country into comprehensive international standards.
ISO/TC209 expects to produce a family of 12 documents encompassing the major aspects of cleanrooms and associated controlled environments. The first of these documents, “Classification of Airborne Particulate Cleanliness for Cleanrooms and Clean Zones” will be published within six months, the remainder in three to six month intervals over the next three years. So that the cleanroom industry will be positioned to start the next century with global cleanroom standards in place, ISO/TC209 has set itself a deadline of 1999 for completion of these 12 documents.
Forming ISO/TC209
In the early 1990s, the work of establishing a common European standard for cleanrooms and cleanroom activities among its 19 member nations was begun under the auspices of the European Committee for Standardization (CEN). In 1992, efforts were begun in the United States when, at the instigation of the Institute of Environmental Sciences (the Institute), the American National Standards Institute (ANSI) petitioned the ISO to create a new technical committee. Called “Cleanrooms and Associated Controlled Environments,” the new committee was designed to complement and, where appropriate, supersede CEN efforts. The Institute was authorized by ANSI to act as Secretariat for the administrative and technical activities of ISO/TC209. Formally established in May 1993, ISO/TC209 held its first organizational meeting in November of that year.
The mission of ISO/TC209 was clearly defined and specific parameters as to what the committee would and would not do were established.
Do`s…
Criteria for cleanrooms and related environmentswere to be standardized. They must be measurable and verifiable.
Trade barriers were to be eliminated.
Voting was by consensus.
ISO standards would be non-mandatory.
Do Not`s…
Cleanrooms would not be defined by user-specific applications.
Cleanrooms would not be defined by microbial limits.
No standard would be instituted that could cause a major economic impact on a specific nation.
Activities
The process of creating an international family of standards by consensus is both tedious and rewarding. It requires patience to listen to the rationale of others, to find common ground, to compromise and to defend decisions based on the common good. The spirit of cooperation among the members of the seven Working Groups and the members of the ISO/TC209 Technical Committee has been excellent. This cooperation has led to viable results in one-half the time normally required for developing something as complex as international standards.
Each nation has a national technical body that supports its ISO/TC209 efforts. In the U.S. it is the U.S. Technical Advisory Group (TAG) of ISO/TC209, authorized by ANSI and administered by the Institute. Membership on the U.S. TAG is open to professional societies, trade associations and government agencies only. TAG members who have voting privileges are: AAMI, AGS, ASHRAE, ASTM, ASQC, FDA, HIMA, NASA, NEBB, PDA, PMA, Sandia National Labs, Sematech, SEMI, and USP. Non-voting members are AAAR, ANSI, GSA, and NIST.
Many of the Institute`s Recommended Practices (RPs) and much of Federal Standard 209E are being incorporated into the new ISO standards, although FS-209E will comprise only about 10 to 15 percent of the entire family of ISO Cleanroom Standards. ISO protocol requires a very specific pattern for the development of international standards. ISO/TC209 must follow this protocol, which allows for opportunities to review decisions and, where appropriate, incorporate objections raised, including all ISO member nations in the deliberation process. Although time-consuming, the process is requisite to develop a truly valuable international standard that all parties can subscribe to. (The ISO protocol for international standards document development is shown in Table 1. Refer to Table 2 for the current status of ISO/TC209 activities, which also includes the master schedule of proposed document production.)
Draft International Standard (DIS) 14644-1 “Classification of Airborne Particulate Cleanliness for Cleanrooms and Clean Zones” is currently “out for comment” by the 85 member nations of ISO and for formal vote by the 18 “P” nations of ISO/TC209. If there are no significant objections, this DIS will automatically become the first formal international standard produced by ISO/TC209 sometime between December 1996 and February 1997, depending on backlog and production schedules at ISO`s headquarters in Geneva, Switzerland.
While air cleanliness criteria have not changed appreciably, three new classes of cleanliness have been proposed–two cleaner and one dirtier–to accommodate, on the one hand, improved technology in measuring and handling submicron particles (ISO 1 and ISO 2) and also manufacturing processes where a higher controlled particle count is required to satisfy regulatory criteria (ISO 9). n
Richard A. Matthews is chairman of ISO/TC209 and a past president of the Institute of Environmental Sciences. He is also president and founder of Filtration Technology, Inc. (Greensboro, NC) and a member of the CleanRooms Editorial Advisory Board.
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