ISO/TC 209 Enters New Territory with Three 14644 Cleanroom Standards

Roberta Burrows, IEST Secretariat for ANSI, ISO Technical Committee 209: Cleanrooms and associated controlled environments

While the cleanroom world continues to digest the ISO 14644-1 and -2 revisions from ISO/TC 209, three new parts in the ISO 14644 standards series may soon be grabbing their share of the attention. The latest standards represent new territory for ISO/TC 209 in two areas: cleaning methods and the suitability of equipment for cleanrooms and associated controlled environments.  The documents have reached the public review stage and are scheduled to be available from IEST on the dates indicated below.

Of course, certain industries have specific regulations or requirements regarding cleaning or equipment suitability already “on the books.” But ISO standards are purposefully developed to provide generic guidance. Therefore, the ultimate decision on whether (and how) the standards apply will need review by the customer and supplier.

Want your say after reading the standards or have a question? A panel discussion on the ISO 14644 standards is scheduled on May 4 during ESTECH 2016, the IEST Annual Technical Meeting in sunny Arizona. Feedback on the proposed standards will be welcome, as they’ll be out for vote with global experts, including the United States Technical Advisory Group (US TAG). This is your chance to participate in the standards development process and offer your insights. In particular, the new standards covering assessment methodologies for equipment and materials used in cleanrooms and controlled environments (see below) may generate significant interest by manufacturers and specifiers alike.

1) ISO/DIS 14644-13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classification (Projected availability is February 11, 2016)

This will be the public’s first look at Part 13 of the ISO 14644 series. This draft international standard will address cleaning to a specified degree on a cleanroom surface, equipment surface in a cleanroom, or surface of a material in a cleanroom. (In this document, the term surface is considered to be a solid.) Guidance is provided on the assessment of cleaning methods for achieving the required surface cleanliness levels specified in ISO 14644-9 and -10. Different cleaning methods may be necessary depending on the degree of cleanliness required. The selection procedure considers aspects such as surface description, cleanliness specifications, types of contamination, cleaning techniques, and material compatibility. Guidance is provided on assessing cleaning efficacy.

2) ISO/FDIS 14644-14: Assessment of suitability for use of equipment by airborne particle concentration (Projected availability is February 20, 2016)

ISO/TC 209’s first foray into the subject of equipment suitability is reaching Final Draft International Standard stage. ISO 14644-14 originally began with a broader scope but was divided into two parts—ISO 14644-14 and -15 (see below)—to separately cover particle and chemical concentration.  ISO /FDIS 14644-14 details a methodology to assess the suitability of equipment with respect to airborne particle cleanliness as specified in ISO 14644-1. As noted previously, the document clarifies that supplemental guidelines or restrictions from regulatory agencies can require appropriate adaptation of the assessment methodology.

3) ISO/DIS 14644-15: Assessment of suitability for use of equipment and materials by airborne chemical concentration (Projected availability is April 7, 2016)

Another draft reaching its first public review is ISO/DIS 14644-15. This part was spun off from the original equipment standard in order to focus on suitability by airborne chemical concentration. This standard provides requirements and guidance for assessing the chemical airborne cleanliness of equipment and materials which are linked to ISO 14644-8. ISO 14644-8 establishes the levels of air chemical cleanliness in terms of airborne concentrations of specific chemical substances (individual, group or category) and provides a protocol to include test methods, analysis, and time-weighted factors within the specification for the level.

If you finished this article and were enthralled by the standards under development, you may just be the person we need to join us in reviewing and developing standards. Please contact the ISO Member Body in your country. In the United States, IEST is the Administrator to the US TAG to ISO/TC 209. US TAG members review and debate the merits of the ISO/TC 209 standards and prepare the US voting position. Experts are also needed to attend the international ISO working group meetings. Please contact IEST Technical Program Manager Jennifer Sklena (jsklena@iest.org) for further information on providing valuable volunteer service to your country and industry.

While the dates shown are as indicated by ISO, there may be unforeseen delays. If you don’t find the documents in the IEST Bookstore, please contact Jennifer (jsklena@iest.org) regarding progress and placement on the “waiting list.”

As always, the Secretariat welcomes feedback from the community. Please do not hesitate to contact me directly at executive@iest.org.

 

 

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