by Richard A. Matthews
The past few months have been a very productive time in the creation of the new Global Cleanroom Standards by the ISO Technical Committee (ISO/TC209) “Cleanrooms and associated controlled environments.”
Concurrently, interest in these new standards is at an all-time high.
At the Irish Cleanroom Society Meeting in Dublin, Ireland, in May 2000, the main theme was the impact of the new ISO standards on cleanroom design and operation. That same month at the 15th Symposium of the International Confederation of Contamination Control Societies (ICCCS) hosted by the R3 Nordic Society in Copenhagen, Denmark, the main topic of interest was also the new ISO cleanroom standards.
The ISO/TC209 Technical Committee met in Copenhagen and took the following actions to push along the final steps for the creation of this family of standards.
Three standards were deemed sufficiently mature technically and editorially to be elevated to the DIS (Draft International Standard) stage and be sent out to all ISO nations for a DIS approval vote.*
These three documents are: 14644-3 “Metrology and Test Methods,” which details the various test methods for evaluating cleanrooms; 14644-5 “Cleanroom Operations,” which covers all aspects of effectively and efficiently operating a cleanroom on a daily basis; and the 14644-7 document, “Enhanced Clean Devices.”
However, it should be noted that at this Copenhagen meeting, ISO/TC209 elected to change the title of 14644-7 to “Separative Enclosures (Clean Air Hoods, Glove Boxes, Isolators & Minienvironments).” The 14644-7 document basically covers self-contained clean enclosures in which there are no personnel and for which there is a very distinctive barrier to the surrounding space.
Two additional standards that had previously passed the DIS stage vote and have now been modified to include comments made by the ISO voting nations were deemed ready for the FDIS (Final Draft International Standard) stage.
These two documents are 14698-1 “Biocontamination General Principles” and 14698-2 “Biocontamination Evaluation and Interpretation of Biocontamination Data.” They are especially valuable for healthcare industries.
ISO Geneva will send them out for an FDIS vote by all the nations of ISO. If they pass this FDIS vote, they will automatically be issued as formal ISO Standards.
TC/209 also moved 14644-6 “Terms, Definitions & Units” closer to the DIS Stage. Originally this document was to be issued upon completion of all the other ISO/TC209 documents. However, because 14644-6 is being written concurrently with the other documents, ISO/TC209 deemed it appropriate to elevate it to the DIS Stage as soon as possible. This 27-page document of clearly defined terms, definitions and units will become a DIS before the end of 2000.
The final document action taken by ISO/TC209 in Copenhagen was to agree to reduce 14698-3, “Biocontamination Methodology for Measuring the Efficiency of Process of Cleaning and/or Disinfecting Unit Surfaces Bearing Biocontaminated Soiling or Biofilms,” from a potential ISO Standard to an ISO Technical Report. Document 14698-3 was deemed too specific in scope to meet the generic criteria required of all the other ISO/TC209 documents. Therefore, it will not become an ISO standard at this time.
Two additional documents, 14644-2 “Specifications for Testing and Monitoring to Prove Continued Compliance with ISO 14644-1” and 14644-7 “Design and Construction,” are currently out for FDIS vote. Assuming a favorable vote, these two documents are expected to be issued as formal ISO Standards within the next few months.
Two other significantly related actions happened in May which support the activity and value of this new family of ISO/TC209 Global Cleanroom Standards.
The Institute of Environmental Sciences & Technology (IEST), which is the appointed caretaker of US Federal Standard 209E, “Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones,” made a formal decision to recommend that the US Government discontinue the use and maintenance of US Federal Standard 209E and further adopt the use of ISO 14644-1 and ISO 14644-2. [See “WG 100: Mission accomplished,” CleanRooms, June 2000, p. 1.]
This recommendation to the US Government is predicated upon the fact that the principles embodied in US Federal Standard 209E have been addressed in these two new ISO standards. Adoption of these ISO standards will also promote global commerce and harmonization of standards. Action by the US Government on this IEST recommendation is expected before year-end.
The IEST was accredited by the American National Standards Institute (ANSI) in May (see “IEST pen becomes sword,” p. 1) as an official Standards Writing Organization. This allows selected IEST Recommended Practices to be elevated to American National Standards. These IEST Recommended Practices can then be built around end-user specific needs, which ISO standards only address in generic terms. This can be particularly important to key industry users of cleanrooms.
The IEST is in the enviable position of having contributed significantly to the creation of the new ISO global cleanroom standards and now stands poised to meet end-user specific needs for clarification and guidance.
As ANSI Standards, these selected IEST Recommended Practices become more valuable to the cleanroom community by addressing specific needs and by establishing referee performance criteria.
The ISO/TC209 Copenhagen meeting this past May, along with the other significant events involving the IEST and the changing status of US Federal Standard 209E, represent the culmination of the work performed by both the ISO Technical Committee members and key IEST personnel.
Eight new ISO cleanroom standards have been effectively moved much closer to publication and reality. Only one more, 14644-8 “Molecular Contamination,” needs to be advanced to the DIS stage. This is expected in 2001.
- NOTE: The DIS stage requires translation into French and German plus a 30-step process within the ISO in Geneva for proper document format and preparation. This process adds 3-6 months to the publication of DIS documents.
Richard A. Matthews is founder of Filtration Technology Inc. (Greensboro, NC) and president of Micron Video International. He is chairman of the International Organization for Standardization Technical Committee ISO/TC209 “Cleanrooms and associated clean environments,” and past president of the Institute of Environmental Sciences and Technology. He is on the CleanRooms Editorial Advisory Board.