UPDATE ON ISO 14644 REVISIONS

Revisions to ISO 14644-1 and ISO 14644-2 are now available as Draft International Standards (DIS). Order Now



ISO/TC 209 Adds Two New Working Groups

Revised ISO Standards Now Available

Confused About the Latest ISO 14644 Revisions?

Which Versions of ISO 14644-1 and -2 Should I Use?



ISO/TC 209 Adds Two New Working Groups

ISO/TC 209, the Technical Committee on Cleanrooms and associated controlled environments, has recently added two new Working Groups to its roster. These new working groups are in the process of developing new international standards addressing the Assessment of suitability of equipment and materials for cleanrooms, and Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications.

US Citizens, who work for a company headquartered in the United States and have an interest in reviewing and voting on these documents, can participate by joining the US Technical Advisory Group (TAG) to ISO/TC 209. Contact IEST at iestservices@iest.org for more information about joining the TAG.


New Sampling and Classification Methods Set in Revised ISO Cleanroom Standards, Now Available

A new principle for selection of cleanroom sample locations is one of the major changes in the revised ISO 14644 standards available from the Institute of Environmental Sciences and Technology (IEST), the Secretariat for ISO Technical Committee 209 (ISO/TC 209): Cleanrooms and associated controlled environments. Users of the current ISO 14644 Cleanrooms and associated controlled environments standards are urged to review the new sampling plan in ISO/DIS 14644-1—Part 1: Classification of air cleanliness by particle concentration and ISO/DIS 14644-2—Part 2: Specifications for monitoring and periodic testing to prove continued compliance with ISO 14644-1, in comparison to the previous approach. Read a peer-reviewed analysis of the standards, which explains the sampling plan and is authored by members of Working Group 1.

These documents, together considered the cornerstone of the ISO 14644 Cleanroom Standards Series, are available from IEST as Draft International Standards (DIS). Importantly, ISO/DIS 14644-1 and 14644-2 may be used as trade reference per agreement between customers and suppliers, necessitating an urgent need for understanding of the revised provisions by those involved in contamination control.

According to the ISO/TC 209 Working Group experts who developed the revisions, new provisions include a simplified classification process based on a more accurate scientific sampling method. The new statistically based plan for selecting sample locations calls for a greater number of locations, but in turn eliminates the need to apply a statistical test to the data. This approach reportedly allows for different concentration levels in different parts of the cleanroom and is designed to ensure with a given statistical confidence that at least 90% of the cleanroom area complies with the maximum particle concentration.

In January 2011, the Journal of the IEST published an article developed by the experts of WG1 (the experts who developed the new revisions) that detailed the statistics behind the revised methods. It is recommended by the ISO Technical Committee that the industry view the statistics article in conjunction with the DIS versions.

During the 2011 DIS ballot more than 200 comments were received. The comments are being reviewed and a second DIS may be issued in 2012.

To order the 2010 DIS versions of ISO 14644-1 and 14644-2, go to the IEST bookstore.

Please note: In addition to the new DIS versions, IEST will continue to sell the 1999 versions of the Standards until the new versions are adopted as International Standards (thus replacing the previous Standards).

Confused About the Latest ISO 14644 Revisions?

The newly released revisions to Parts 1 and 2 of the ISO 14644 Cleanroom Standards have triggered a maze of questions in the contamination control community. Did you know…

  • The new Draft International Standards (DIS) require use of a statistical method for selecting cleanroom sample locations. Why were these changes made and what steps must you take to comply?
  • Both the original Standards and the DIS versions may be used as trade reference per agreement between customers and suppliers. Which version should you use?
  • The documents may undergo a second DIS vote before they are submitted as Final Draft International Standards (FDIS) and then published as Standards. How can you voice your comments?

 These and other questions will be discussed in a continuing education training course offered by IEST at Fall Conference 2012.

Understanding the Impact of ISO 14644 Revisions

The instructor will be IEST Senior Faculty member Robert Mielke, Secretary for ISO/TC 209 and a member of ISO/TC 209 Working Group 1, which wrote ISO 14644-1 and ISO 14644-2. In addition to a certificate of attendance and CEUs, registrants received both versions — the 1999 Standard and the new DIS — of both Parts 1 and 2, as well as a technical paper explaining the statistics behind the revised methods.

Which Versions of ISO 14644-1 and -2 Should I Use?

Review the Statistics

The contamination control community now finds itself choosing between the two versions of the cornerstone ISO cleanroom standards titled ISO 14644-1 and -2. Both the original Standard versions and the revised Draft International Standard (DIS) versions may be used as trade reference per agreement between customers and suppliers. Which version you choose for reference is a decision that should be reviewed and addressed by the customer and supplier. The new versions incorporate new provisions for cleanroom sample locations.

The Journal of the IEST has issued a special edition featuring a peer-reviewed paper, developed by the experts of WG1 (the experts who developed the new revisions), that details the statistics behind the revised methods. It is recommended by the ISO Technical Committee that the industry view this statistics paper in conjunction with the DIS versions. It is also important to note that a Draft International Standard may undergo further revision before it is presented as a Final Draft International Standard (FDIS) and then published as a Standard.

Use the Correct Title for Specification

While you may use either the Standard or DIS version of the documents, you should specify the correct title in any references. For example, if you are specifying to the initial versions that were published as ISO Standards and have been accepted as American National Standards under the IEST lead, you would specify to ISO 14644-1:1999 and ISO 14644-2:2000. If you review the DIS version and choose to specify to the draft, you should indicate that you are specifying to ISO/DIS 14644-1 (2010) and ISO/DIS 14644-2 (2010) to avoid confusion.

As with any monumental change, there will be discussion and questions. Watch the ISO pages of the IEST website for further developments.