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<p class="MsoBodyText"><span lang="EN-GB">This document</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">provides information on the determination of particulate loads;</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">reports on established methods for a comprehensive risk analysis on potential particle sources and related risks in design, manufacturing, and application of devices.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document is applicable to medical devices that are used to provide intravenous access to patients to deliver liquids.</span></p>
<p class="Note"><span lang="EN-GB">NOTE<span style="mso-tab-count: 1;"> </span>For routes of administration that are not intravenous, the information in this document might be relevant to assist in the identification of sources of potential particulate contamination.</span></p>
Reģistrācijas numurs (WIID)
83166
Darbības sfēra
<p class="MsoBodyText"><span lang="EN-GB">This document</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">provides information on the determination of particulate loads;</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">reports on established methods for a comprehensive risk analysis on potential particle sources and related risks in design, manufacturing, and application of devices.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document is applicable to medical devices that are used to provide intravenous access to patients to deliver liquids.</span></p>
<p class="Note"><span lang="EN-GB">NOTE<span style="mso-tab-count: 1;"> </span>For routes of administration that are not intravenous, the information in this document might be relevant to assist in the identification of sources of potential particulate contamination.</span></p>
