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On November 29, 2001 the U.S. General Services Administration (GSA) issued a notice of cancellation for the Federal Standard 209E (FED-STD-209E). This notice is basically stating that the standard will no longer be revised, though about 60% of U.S. companies are still designing their cleanroom to the old standard.

The decision was based on the recommendation of the IEST, who assisted in developing the standard. The IEST recommended the International Standard ISO 14644 be used as a standard for cleanrooms and set the guidelines for the global contamination control community. In 1999 the document was submitted as an American National Standard and has since been adopted as ANSI/IEST/ISO 14644-1.

ISO 14644 consists of 8 documents that take into consideration all aspects of design, specifications and control of cleanrooms, clean hoods and other associated environmentally controlled “clean” environments in all three possible states, as-built, at-rest and operational. The ISO 14644 standards are more appropriate for the sensitive processes found in the aerospace, microelectronics and pharmaceutical industries and is a true international standard that governs all aspects regarding cleanroom design, operation, monitoring and testing procedures.

To give a general overview of the 8 documents that make up the ISO 14644 I have briefly described each section of the ISO 14644 below:

ISO 14644-1 is an 18 page document that specifies the classifications of air cleanliness for cleanrooms, hoods, zones and other associated environments.

ISO 14644-2 is a 7 page document that specifies the monitoring and testing procedures to prove continued compliance with ISO 14644-1.

ISO 14644-3 is a 65 page document covering testing procedures for cleanrooms and clean hoods/zones (unidirectional and non-laminar) in all three states (as-built, at-rest and operational)

ISO 14644-4 is a 51 page documents that details the design and construction issues for new start-up cleanrooms.

ISO 14644-5 is a 44 page document that specifies the requirements for general cleanroom operations. This document covers all classes of cleanrooms and is intended as a general guide, which does not get into the specifics of any applications or testing or monitoring procedures.

ISO 14644-6 is a 21 page document that defines the vocabulary used in the ISO 14644 documents

ISO 14644-7 is a 52 page document that specifies the minimum requirements for the design, construction, installation, test and approval of separative devices such as clean air hoods, gloveboxes, isolators and mini-environments.

ISO 14644-8 is an 18 page document that covers the classification of airborne molecular contamination (AMC) in cleanrooms and associated controlled environments under operational conditions for applications where contamination is a risk to the product or process. ISO 14644-8 includes testing procedures, analysis and time weighted factors within the specification for classification.

Two additional documents, ISO 14698, parts 1 & 2, were released in September of 2003. Part 1 deals with the general principles and methods of biocontamination control, and part 2 explains the evaluation and interpretation of biocontamination data.

If anyone has any comments or questions regarding the ISO 14644 standards, classifications or any other related topic, click the comments link below to join in the ongoing discussion.