By Tony Harrison
Changes in ISO 14644-1 to improve confidence in quality for critical life-science applications. Tony Harrison, UK Subject Matter Expert to ISO TC209 Working Group 01, April 2012.
ISO 14644-1, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness is under revision as part of the normal ISO periodic review cycle. An international working group of subject matter experts, ISO TC209 Working Group 01, has been meeting to review the current ISO 14644 document and make recommendations for improvements. Consulting with expert statisticians, the working group is proposing changes to the classification method and also improving the document by incorporating the essential elements of ISO 14644-3, Cleanrooms and associated controlled environments — Part 3: Test methods, to help improve confidence in the quality of results