ISO/TC 121/SC 4

Project No.ISO 19223-2:2025
Title<p class="MsoBodyText"><span lang="EN-GB">This document defines terms for:</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]--><em style="mso-bidi-font-style: normal;"><span lang="EN-GB">high-frequency oscillatory ventilation</span></em><span lang="EN-GB"> (HFOV);</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]--><em style="mso-bidi-font-style: normal;"><span lang="EN-GB">percussive ventilation</span></em><span lang="EN-GB">, including <em style="mso-bidi-font-style: normal;">high-frequency percussive ventilation</em> (HFPV);</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]--><em style="mso-bidi-font-style: normal;"><span lang="EN-GB">jet ventilation</span></em><span lang="EN-GB">, including <em style="mso-bidi-font-style: normal;">high frequency jet ventilation</em> (HFJV);</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">modes that combine high-frequency and physiological-rate ventilation.</span></p> <p class="MsoBodyText"><span lang="EN-GB">It is applicable:</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">in <em style="mso-bidi-font-style: normal;">lung ventilator</em> and <em style="mso-bidi-font-style: normal;">breathing</em>-therapy device standards,</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">in health informatics standards,</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">for labelling on <em style="mso-bidi-font-style: normal;">medical electrical equipment</em> and <em style="mso-bidi-font-style: normal;">medical electrical systems,</em></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">in <em style="mso-bidi-font-style: normal;">medical electrical equipment</em> and <em style="mso-bidi-font-style: normal;">medical electrical system</em> instructions for use and <em style="mso-bidi-font-style: normal;">accompanying documents,</em></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">for <em style="mso-bidi-font-style: normal;">medical electrical equipment</em> and <em style="mso-bidi-font-style: normal;">medical electrical systems</em> interoperability, and</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">in electronic health records.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document is also applicable to those accessories intended by their <em style="mso-bidi-font-style: normal;">manufacturer</em> to be connected to a <em style="mso-bidi-font-style: normal;">ventilatorbreathing system</em> or to a <em style="mso-bidi-font-style: normal;">ventilator</em>, where the characteristics of those accessories can affect the basic safety or essential performance of the <em style="mso-bidi-font-style: normal;">ventilator</em> or <em style="mso-bidi-font-style: normal;">ventilator</em> <em style="mso-bidi-font-style: normal;">breathing system</em>.</span></p> <p class="Note"><span lang="EN-GB">NOTE<span style="mso-tab-count: 1;">            </span>This document can also be used for other applications relating to <em style="mso-bidi-font-style: normal;">lung</em> <em style="mso-bidi-font-style: normal;">ventilation</em>, including non-electrical devices and equipment, research, description of critical events, forensic analysis and adverse event (vigilance) reporting systems.</span></p>
Registration number (WIID)86176
Scope<p class="MsoBodyText"><span lang="EN-GB">This document defines terms for:</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]--><em style="mso-bidi-font-style: normal;"><span lang="EN-GB">high-frequency oscillatory ventilation</span></em><span lang="EN-GB"> (HFOV);</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]--><em style="mso-bidi-font-style: normal;"><span lang="EN-GB">percussive ventilation</span></em><span lang="EN-GB">, including <em style="mso-bidi-font-style: normal;">high-frequency percussive ventilation</em> (HFPV);</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]--><em style="mso-bidi-font-style: normal;"><span lang="EN-GB">jet ventilation</span></em><span lang="EN-GB">, including <em style="mso-bidi-font-style: normal;">high frequency jet ventilation</em> (HFJV);</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">modes that combine high-frequency and physiological-rate ventilation.</span></p> <p class="MsoBodyText"><span lang="EN-GB">It is applicable:</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">in <em style="mso-bidi-font-style: normal;">lung ventilator</em> and <em style="mso-bidi-font-style: normal;">breathing</em>-therapy device standards,</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">in health informatics standards,</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">for labelling on <em style="mso-bidi-font-style: normal;">medical electrical equipment</em> and <em style="mso-bidi-font-style: normal;">medical electrical systems,</em></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">in <em style="mso-bidi-font-style: normal;">medical electrical equipment</em> and <em style="mso-bidi-font-style: normal;">medical electrical system</em> instructions for use and <em style="mso-bidi-font-style: normal;">accompanying documents,</em></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">for <em style="mso-bidi-font-style: normal;">medical electrical equipment</em> and <em style="mso-bidi-font-style: normal;">medical electrical systems</em> interoperability, and</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">in electronic health records.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document is also applicable to those accessories intended by their <em style="mso-bidi-font-style: normal;">manufacturer</em> to be connected to a <em style="mso-bidi-font-style: normal;">ventilatorbreathing system</em> or to a <em style="mso-bidi-font-style: normal;">ventilator</em>, where the characteristics of those accessories can affect the basic safety or essential performance of the <em style="mso-bidi-font-style: normal;">ventilator</em> or <em style="mso-bidi-font-style: normal;">ventilator</em> <em style="mso-bidi-font-style: normal;">breathing system</em>.</span></p> <p class="Note"><span lang="EN-GB">NOTE<span style="mso-tab-count: 1;">            </span>This document can also be used for other applications relating to <em style="mso-bidi-font-style: normal;">lung</em> <em style="mso-bidi-font-style: normal;">ventilation</em>, including non-electrical devices and equipment, research, description of critical events, forensic analysis and adverse event (vigilance) reporting systems.</span></p>
StatusStandarts spēkā
ICS group11.040.10
01.040.11