What are the requirements for calibration certificates of test equipment?

The requirement for valid calibration certificates of test equipment is defined in the updated standard and references ISO 21501-4 relating to the calibration of airborne particle counters.

It is important to note that particle monitoring operating in process is different from particle monitoring for environmental classification. All Grade environments should be routinely monitored while in operation. Monitoring locations should be identified based on a formal risk analysis with results taken during the cleanroom classification testing of the cleanroom air device.