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<p><span lang="EN-GB">This document gives guidance on designating medical devices to cleaning classification categories, attributes used for medical device cleaning classification category, and designation of a cleaning process.</span></p>
<p><span lang="EN-GB">The cleaning classification category is comprised of two parts:</span></p>
<ol style="list-style-type: lower-alpha;">
<li><span lang="EN-GB">designate medical devices to a product family;</span></li>
<li><span lang="EN-GB">designate product families to cleaning processes.</span></li>
</ol>
<p><span lang="EN-GB">NOTE 1 This allows grouping of medical devices into cleaning classification categories during cleaning and identification of master products during cleaning validation.</span></p>
<p><span lang="EN-GB">This document is applicable to manufacturers devising cleaning methods and instructions for processing. It also applies to any processing facility where medical devices are cleaned.</span></p>
<p><span lang="EN-GB">This document does not cover processing of single-use medical devices provided as sterile before use and textile devices.</span></p>
<p><span lang="EN-GB">NOTE 2 Manual cleaning steps before automated cleaning do not include steps that are considered point of use treatment that can be specified.</span></p>
<p><span lang="EN-GB">NOTE 3 Microbiocidal processes (sanitization, disinfection, sterilization) are not in the scope of the medical device cleaning classification categories.</span></p>
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<p><span lang="EN-GB">This document gives guidance on designating medical devices to cleaning classification categories, attributes used for medical device cleaning classification category, and designation of a cleaning process.</span></p>
<p><span lang="EN-GB">The cleaning classification category is comprised of two parts:</span></p>
<ol style="list-style-type: lower-alpha;">
<li><span lang="EN-GB">designate medical devices to a product family;</span></li>
<li><span lang="EN-GB">designate product families to cleaning processes.</span></li>
</ol>
<p><span lang="EN-GB">NOTE 1 This allows grouping of medical devices into cleaning classification categories during cleaning and identification of master products during cleaning validation.</span></p>
<p><span lang="EN-GB">This document is applicable to manufacturers devising cleaning methods and instructions for processing. It also applies to any processing facility where medical devices are cleaned.</span></p>
<p><span lang="EN-GB">This document does not cover processing of single-use medical devices provided as sterile before use and textile devices.</span></p>
<p><span lang="EN-GB">NOTE 2 Manual cleaning steps before automated cleaning do not include steps that are considered point of use treatment that can be specified.</span></p>
<p><span lang="EN-GB">NOTE 3 Microbiocidal processes (sanitization, disinfection, sterilization) are not in the scope of the medical device cleaning classification categories.</span></p>
