New Changes to ISO clean room standards

Revision of ISO clean Room Standards

ISO has a series of standards dedicated to clean rooms, outlining the practices and procedures required to manage the risk of contamination. The first two in the series have just been updated to take into account the latest technological developments and market requirements. Revised clean room standards incorporate best practices for contamination control.

ISO 14644-1:2015, Clean rooms and associated controlled environments – Part 1: Classification of air cleanliness by particle concentration, and ISO 14644-2:2015, Clean rooms and associated controlled environments – Part 2: Monitoring to provide evidence of clean room performance related to air cleanliness by particle concentration, provide the framework for classifying and monitoring the cleanliness of the air in clean rooms.

The new version includes the following changes:

• The number of measuring points is no longer calculated as the square root of the surface but given in a table.
• 5 µm particles for ISO 5 has been dropped from the limit value table.
• No more statistical UCL calculation: there is no need to perform an observation of all measuring points in the room any longer. Each single measuring point is considered individually and has to meet the limit value.
• The tubing length to the particle counter should be less than 1 m.
• The classification number, the sample volumes/ measuring period as well as the cancellation criterion remain unchanged compared to the version of 1999.

The revision of ISO 14644-1 and -2 are so critical to the estimated $14 billion clean room industry.