<p><span lang="EN-GB">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).</span></p>
<p><span lang="EN-GB">NOTE Where regulatory agencies impose supplementary guidelines or restrictions, appropriate adaptation of the assessment methodology can be required.</span></p>
<p><span lang="EN-GB">This document is not applicable to the following items:</span></p>
<ul>
<li><span lang="EN-GB">assessment of suitability with respect to biocontamination;</span></li>
<li><span lang="EN-GB">testing for suitability of decontamination agents and techniques;</span></li>
<li><span lang="EN-GB">cleanability of equipment and materials;</span></li>
<li><span lang="EN-GB">requirements on design of equipment and selection of materials;</span></li>
<li><span lang="EN-GB">physical properties of materials (e.g. electrostatic, thermal properties);</span></li>
<li><span lang="EN-GB">optimizing performance of equipment for specific process applications;</span></li>
<li><span lang="EN-GB">selection and use of statistical methods for testing;</span></li>
<li><span lang="EN-GB">protocols and requirements for local safety regulations.</span></li>
</ul>
Registration number (WIID)
91615
Scope
<p><span lang="EN-GB">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).</span></p>
<p><span lang="EN-GB">NOTE Where regulatory agencies impose supplementary guidelines or restrictions, appropriate adaptation of the assessment methodology can be required.</span></p>
<p><span lang="EN-GB">This document is not applicable to the following items:</span></p>
<ul>
<li><span lang="EN-GB">assessment of suitability with respect to biocontamination;</span></li>
<li><span lang="EN-GB">testing for suitability of decontamination agents and techniques;</span></li>
<li><span lang="EN-GB">cleanability of equipment and materials;</span></li>
<li><span lang="EN-GB">requirements on design of equipment and selection of materials;</span></li>
<li><span lang="EN-GB">physical properties of materials (e.g. electrostatic, thermal properties);</span></li>
<li><span lang="EN-GB">optimizing performance of equipment for specific process applications;</span></li>
<li><span lang="EN-GB">selection and use of statistical methods for testing;</span></li>
<li><span lang="EN-GB">protocols and requirements for local safety regulations.</span></li>
</ul>
