This document specifies a methodology to assess the suitability of equipment (e.g. machinery, measuring equipment, process equipment, components and tools) for use in cleanrooms and associated controlled environments, with respect to airborne particle cleanliness as specified in ISO 14644-1. Particle sizes range from 0,1 µm to equal to or larger than 5 µm (given in ISO 14644-1).

NOTE            Where regulatory agencies impose supplementary guidelines or restrictions, appropriate adaptation of the assessment methodology can be required.

This document is not applicable to the following items:

• assessment of suitability with respect to biocontamination;
• testing for suitability of decontamination agents and techniques;
• cleanability of equipment and materials;
• requirements on design of equipment and selection of materials;
• physical properties of materials (e.g. electrostatic, thermal properties);
• optimizing performance of equipment for specific process applications;
• selection and use of statistical methods for testing;
• protocols and requirements for local safety regulations.