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   Federal Standard 209   The present status of international cleanroom standardisation


ISO/TC 209: Cleanrooms and associated controlled environments: Standards in development

Document-No. Short Title Status 04.03
ISO 14644-1 Air cleanliness classification Std. 05.99
ISO 14644-2 Specification for testing cleanrooms to prove continued compliance with ISO 14644-1 Std. 09.00
ISO 14644-3 Metrology and test methods DIS 09.02
ISO 14644-4 Design, construction and start-up Std. 04.01
ISO 14644-5 Operations DIS 07.01
ISO 14644-6 Terms and definitions CD 06.01
ISO 14644-7 Clean air hoods, glove boxes, isolators, minienvironments DIS 02.01
ISO 14644-8 Classification of molecular contamination CD 12.02
ISO 14698-1 Biocontamination control:  General principles and measurement of biocontamination of air, surfaces, liquids and textiles FDIS 04.03
ISO 14698-2 Biocontamination control:  Evaluation and interpretation of biocontamination data FDIS 04.03
ISO 14698-3 Biocontamination control:  Measuring the efficiency of cleaning and disinfection processes for inert surfaces DIS 02.99

The standardization effort is split into two families of standards:
  • the ISO 14644 series covering general contamination control topics;
  • the ISO 14698 series on biocontamination control issues.
The column 'Status 04.03' in Table 2 identifies the actual state of approval of each work item on the 12th February 2003, the approval procedure being subdivided into three stages:
  • an informal circulation as Committee Draft CD, with the objective of inviting technical comments from the nations actively involved in the ISO/TC 209 work;
  • a first formal circulation as Draft International Standard DIS for the parallel ISO and CEN enquiry, inviting technical and editorial comments and requesting a generic statement on the merits of the draft by means of a preliminary vote;
  • and finally the second formal circulation as Final Draft International Standard FDIS, for the parallel ISO and CEN voting leading - if successful - to approval and subsequent publication in the ISO and CEN collections of standards.
As is evident, three documents have already achieved the status of formally approved International and European Standards, and others are to follow soon.

In addition to the work items listed in Table 2, work is soon to commence on an international standard devoted to the important issue of surface cleanliness, and an ad-hoc task force has recently been established by ISO/TC 209 for assessing whether the subject of cleanroom garments also merits the elaboration of an international standard.