ISO/TC 121/SC 3

Projekta Nr.ISO 80601-2-84:2023
Nosaukums<p class="PARAGRAPH"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria;">This </span><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">document</span><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria;"> applies to the <em style="mso-bidi-font-style: normal;">basic safety</em> and <em style="mso-bidi-font-style: normal;">essential performance</em> of an <em style="mso-bidi-font-style: normal;">EMS</em> <em style="mso-bidi-font-style: normal;">ventilator</em> in combination with its <em style="mso-bidi-font-style: normal;">accessories</em>, hereafter also referred to as <em style="mso-bidi-font-style: normal;">ME equipment:</em> </span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">intended for <em style="mso-bidi-font-style: normal;">patients</em> who need differing levels of support from <em>artificial ventilation</em> including <em style="mso-bidi-font-style: normal;">ventilator-dependent</em> <em style="mso-bidi-font-style: normal;">patients</em>;</span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">intended to be operated by a <em>healthcare professional operator</em>;</span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">intended for use in the <em style="mso-bidi-font-style: normal;">EMS environment</em>; and</span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">intended for invasive or non-invasive <em>ventilation</em>.</span></p> <p class="Note"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">NOTE 2<span style="mso-tab-count: 1;">     </span>An <em style="mso-bidi-font-style: normal;">EMS</em> <em style="mso-bidi-font-style: normal;">ventilator </em>can also be used for transport within a <em style="mso-bidi-font-style: normal;">professional healthcare facility</em>.</span></p> <p class="PARAGRAPH"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria;">An <em style="mso-bidi-font-style: normal;">EMS ventilator</em> is not considered to use a <em style="mso-bidi-font-style: normal;">physiologic closed loop-control system</em> unless it uses a physiological <em style="mso-bidi-font-style: normal;">patient</em> variable to adjust the  <em>artificial</em> <em>ventilation</em> therapy settings.</span></p> <p class="PARAGRAPH"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria;">This </span><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">document</span><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria;"> is also applicable to those <em style="mso-bidi-font-style: normal;">accessories</em> intended by their <em style="mso-bidi-font-style: normal;">manufacturer</em> to be connected to the <em style="mso-bidi-font-style: normal;">ventilator</em> <em style="mso-bidi-font-style: normal;">breathing system</em>, or to an <em style="mso-bidi-font-style: normal;">EMS</em> <em style="mso-bidi-font-style: normal;">ventilator</em>, where the characteristics of those <em style="mso-bidi-font-style: normal;">accessories</em> can affect the <em style="mso-bidi-font-style: normal;">basic safety</em> or <em style="mso-bidi-font-style: normal;">essential performance</em> of the <em style="mso-bidi-font-style: normal;">EMS</em> <em style="mso-bidi-font-style: normal;">ventilator</em>. </span></p> <p class="Note"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">NOTE 3<span style="mso-tab-count: 1;">     </span>If a clause or subclause is specifically intended to be applicable to <em style="mso-bidi-font-style: normal;">ME equipment</em> only, or to <em style="mso-bidi-font-style: normal;">ME systems</em> only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to <em style="mso-bidi-font-style: normal;">ME equipment</em> and to <em style="mso-bidi-font-style: normal;">ME systems</em>, as relevant.</span></p> <p class="PARAGRAPH"><em style="mso-bidi-font-style: normal;"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">Hazards</span></em><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;"> inherent in the intended physiological function of <em style="mso-bidi-font-style: normal;">ME equipment</em> or <em style="mso-bidi-font-style: normal;">ME systems</em> within the scope of this document are not covered by specific requirements in this document except in </span><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; mso-fareast-language: EN-US;">IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.</span></p> <p class="Note"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">NOTE 4</span><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS'; mso-bidi-font-family: 'Arial Unicode MS';"><span style="mso-tab-count: 1;">     </span></span><span style="mso-bidi-font-family: Arial; mso-ansi-language: EN-US;">Additional information can be found in IEC 60601-1:2005+AMD1:2012</span><span lang="EN-GB">+AMD2:2020</span><span style="mso-bidi-font-family: Arial; mso-ansi-language: EN-US;">, 4.2.</span></p> <p class="PARAGRAPH"><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; mso-ansi-language: EN-US; mso-fareast-language: EN-US;">This </span><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">document</span><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; mso-ansi-language: EN-US; mso-fareast-language: EN-US;"> does not specify the requirements for the following:</span></p> <p class="Note"><span lang="EN-GB">NOTE 5<span style="mso-tab-count: 1;">     </span>See ISO/TR 21954 for guidance on the selection of the appropriate <em>ventilator</em> for a given <em>patient</em>.<span style="mso-spacerun: yes;">  </span></span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><em style="mso-bidi-font-style: normal;"><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">ventilators</span></em><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;"> or <em style="mso-bidi-font-style: normal;">accessories</em> intended for <em style="mso-bidi-font-style: normal;">ventilator-dependent</em> <em style="mso-bidi-font-style: normal;">patients</em> in critical care applications, which are given in ISO 80601-2-12. </span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><em><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; mso-bidi-font-family: Cambria;">ventilators</span></em><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; mso-bidi-font-family: Cambria;"> or <em>accessories</em> intended </span><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">for <em>ventilator-dependent</em> <em>patients</em> in the <em>home healthcare environment</em>, which are given in ISO 80601-2-72. </span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><em style="mso-bidi-font-style: normal;"><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; mso-bidi-font-family: Cambria;">ventilators</span></em><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; mso-bidi-font-family: Cambria;"> or <em style="mso-bidi-font-style: normal;">accessories</em> intended </span><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">for anaesthetic applications, which are given in ISO 80601‑2‑13. </span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><em style="mso-bidi-font-style: normal;"><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">ventilators</span></em><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;"> or <em style="mso-bidi-font-style: normal;">accessories</em> intended for ventilatory support equipment (intended only to augment the <em>ventilation</em> of spontaneously breathing <em style="mso-bidi-font-style: normal;">patients</em>), which are given in ISO 80601‑2-79 and ISO 80601-2-80. </span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">obstructive sleep apnoea therapy</span><span style="font-size: 9.0pt; mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;"> </span><em style="mso-bidi-font-style: normal;"><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">ME equipment</span></em><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">, which are given in ISO 80601‐2‐70. </span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; mso-bidi-font-style: italic;">user</span><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">-powered resuscitators, which are given in ISO 10651‐4. </span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">gas-powered emergency resuscitators, which are given in ISO 10651‐5. </span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><em><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">continuous positive airway pressure</span></em><span style="mso-bookmark: _Hlk126857754;"><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;"> (<em>CPAP</em>) <em>ME equipment</em>.</span></span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">high‐frequency jet <em style="mso-bidi-font-style: normal;">ventilators</em> (HFJVs), which are given in ISO 80601-2-87.</span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">high‐frequency oscillatory <em style="mso-bidi-font-style: normal;">ventilators</em> (HFOVs)</span><!-- [if supportFields]><sup><span style='mso-ascii-font-family:Cambria;mso-hansi-font-family:Cambria'><span style='mso-element:field-begin'></span> REF _Ref69393406 \r \h <span style='mso-spacerun:yes'> </span>\* MERGEFORMAT <span style='mso-element:field-separator'></span></span></sup><![endif]--><sup><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">[44]<!-- [if gte mso 9]><xml> <w:data>08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000D0000005F00520065006600360039003300390033003400300036000000</w:data> </xml><![endif]--></span></sup><!-- [if supportFields]><sup><span style='mso-ascii-font-family:Cambria;mso-hansi-font-family:Cambria'><span style='mso-element:field-end'></span></span></sup><![endif]--><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">, which are given in ISO 80601-2-87.</span></p> <p class="Note" style="margin-left: 18.9pt; tab-stops: 63.8pt;"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">NOTE</span><span lang="EN-GB"> 6<span style="mso-tab-count: 1;">      </span>An <em style="mso-bidi-font-style: normal;">EMS</em> <em style="mso-bidi-font-style: normal;">ventilator</em> can incorporate high-frequency jet or high-frequency oscillatory <em style="mso-bidi-font-style: normal;">ventilation-modes</em>.</span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">respiratory high-flow therapy equipment, which are given in ISO 80601-2-90.</span></p> <p class="Note" style="margin-left: 18.9pt; tab-stops: 63.8pt;"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">NOTE</span><span lang="EN-GB"> 7<span style="mso-tab-count: 1;">      </span>An <em style="mso-bidi-font-style: normal;">EMS</em> <em style="mso-bidi-font-style: normal;">ventilator</em> can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing <em>patients</em>.</span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">oxygen therapy constant flow <em>ME equipment</em>.</span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">cuirass or “iron‐lung” <em style="mso-bidi-font-style: normal;">ventilators</em>.</span></p>
Reģistrācijas numurs (WIID)83438
Darbības sfēra<p class="PARAGRAPH"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria;">This </span><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">document</span><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria;"> applies to the <em style="mso-bidi-font-style: normal;">basic safety</em> and <em style="mso-bidi-font-style: normal;">essential performance</em> of an <em style="mso-bidi-font-style: normal;">EMS</em> <em style="mso-bidi-font-style: normal;">ventilator</em> in combination with its <em style="mso-bidi-font-style: normal;">accessories</em>, hereafter also referred to as <em style="mso-bidi-font-style: normal;">ME equipment:</em> </span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">intended for <em style="mso-bidi-font-style: normal;">patients</em> who need differing levels of support from <em>artificial ventilation</em> including <em style="mso-bidi-font-style: normal;">ventilator-dependent</em> <em style="mso-bidi-font-style: normal;">patients</em>;</span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">intended to be operated by a <em>healthcare professional operator</em>;</span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">intended for use in the <em style="mso-bidi-font-style: normal;">EMS environment</em>; and</span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">intended for invasive or non-invasive <em>ventilation</em>.</span></p> <p class="Note"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">NOTE 2<span style="mso-tab-count: 1;">     </span>An <em style="mso-bidi-font-style: normal;">EMS</em> <em style="mso-bidi-font-style: normal;">ventilator </em>can also be used for transport within a <em style="mso-bidi-font-style: normal;">professional healthcare facility</em>.</span></p> <p class="PARAGRAPH"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria;">An <em style="mso-bidi-font-style: normal;">EMS ventilator</em> is not considered to use a <em style="mso-bidi-font-style: normal;">physiologic closed loop-control system</em> unless it uses a physiological <em style="mso-bidi-font-style: normal;">patient</em> variable to adjust the  <em>artificial</em> <em>ventilation</em> therapy settings.</span></p> <p class="PARAGRAPH"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria;">This </span><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">document</span><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria;"> is also applicable to those <em style="mso-bidi-font-style: normal;">accessories</em> intended by their <em style="mso-bidi-font-style: normal;">manufacturer</em> to be connected to the <em style="mso-bidi-font-style: normal;">ventilator</em> <em style="mso-bidi-font-style: normal;">breathing system</em>, or to an <em style="mso-bidi-font-style: normal;">EMS</em> <em style="mso-bidi-font-style: normal;">ventilator</em>, where the characteristics of those <em style="mso-bidi-font-style: normal;">accessories</em> can affect the <em style="mso-bidi-font-style: normal;">basic safety</em> or <em style="mso-bidi-font-style: normal;">essential performance</em> of the <em style="mso-bidi-font-style: normal;">EMS</em> <em style="mso-bidi-font-style: normal;">ventilator</em>. </span></p> <p class="Note"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">NOTE 3<span style="mso-tab-count: 1;">     </span>If a clause or subclause is specifically intended to be applicable to <em style="mso-bidi-font-style: normal;">ME equipment</em> only, or to <em style="mso-bidi-font-style: normal;">ME systems</em> only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to <em style="mso-bidi-font-style: normal;">ME equipment</em> and to <em style="mso-bidi-font-style: normal;">ME systems</em>, as relevant.</span></p> <p class="PARAGRAPH"><em style="mso-bidi-font-style: normal;"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">Hazards</span></em><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;"> inherent in the intended physiological function of <em style="mso-bidi-font-style: normal;">ME equipment</em> or <em style="mso-bidi-font-style: normal;">ME systems</em> within the scope of this document are not covered by specific requirements in this document except in </span><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; mso-fareast-language: EN-US;">IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.</span></p> <p class="Note"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">NOTE 4</span><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS'; mso-bidi-font-family: 'Arial Unicode MS';"><span style="mso-tab-count: 1;">     </span></span><span style="mso-bidi-font-family: Arial; mso-ansi-language: EN-US;">Additional information can be found in IEC 60601-1:2005+AMD1:2012</span><span lang="EN-GB">+AMD2:2020</span><span style="mso-bidi-font-family: Arial; mso-ansi-language: EN-US;">, 4.2.</span></p> <p class="PARAGRAPH"><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; mso-ansi-language: EN-US; mso-fareast-language: EN-US;">This </span><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">document</span><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; mso-ansi-language: EN-US; mso-fareast-language: EN-US;"> does not specify the requirements for the following:</span></p> <p class="Note"><span lang="EN-GB">NOTE 5<span style="mso-tab-count: 1;">     </span>See ISO/TR 21954 for guidance on the selection of the appropriate <em>ventilator</em> for a given <em>patient</em>.<span style="mso-spacerun: yes;">  </span></span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><em style="mso-bidi-font-style: normal;"><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">ventilators</span></em><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;"> or <em style="mso-bidi-font-style: normal;">accessories</em> intended for <em style="mso-bidi-font-style: normal;">ventilator-dependent</em> <em style="mso-bidi-font-style: normal;">patients</em> in critical care applications, which are given in ISO 80601-2-12. </span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><em><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; mso-bidi-font-family: Cambria;">ventilators</span></em><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; mso-bidi-font-family: Cambria;"> or <em>accessories</em> intended </span><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">for <em>ventilator-dependent</em> <em>patients</em> in the <em>home healthcare environment</em>, which are given in ISO 80601-2-72. </span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><em style="mso-bidi-font-style: normal;"><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; mso-bidi-font-family: Cambria;">ventilators</span></em><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; mso-bidi-font-family: Cambria;"> or <em style="mso-bidi-font-style: normal;">accessories</em> intended </span><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">for anaesthetic applications, which are given in ISO 80601‑2‑13. </span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><em style="mso-bidi-font-style: normal;"><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">ventilators</span></em><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;"> or <em style="mso-bidi-font-style: normal;">accessories</em> intended for ventilatory support equipment (intended only to augment the <em>ventilation</em> of spontaneously breathing <em style="mso-bidi-font-style: normal;">patients</em>), which are given in ISO 80601‑2-79 and ISO 80601-2-80. </span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">obstructive sleep apnoea therapy</span><span style="font-size: 9.0pt; mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;"> </span><em style="mso-bidi-font-style: normal;"><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">ME equipment</span></em><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">, which are given in ISO 80601‐2‐70. </span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; mso-bidi-font-style: italic;">user</span><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">-powered resuscitators, which are given in ISO 10651‐4. </span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">gas-powered emergency resuscitators, which are given in ISO 10651‐5. </span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><em><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">continuous positive airway pressure</span></em><span style="mso-bookmark: _Hlk126857754;"><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;"> (<em>CPAP</em>) <em>ME equipment</em>.</span></span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">high‐frequency jet <em style="mso-bidi-font-style: normal;">ventilators</em> (HFJVs), which are given in ISO 80601-2-87.</span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">high‐frequency oscillatory <em style="mso-bidi-font-style: normal;">ventilators</em> (HFOVs)</span><!-- [if supportFields]><sup><span style='mso-ascii-font-family:Cambria;mso-hansi-font-family:Cambria'><span style='mso-element:field-begin'></span> REF _Ref69393406 \r \h <span style='mso-spacerun:yes'> </span>\* MERGEFORMAT <span style='mso-element:field-separator'></span></span></sup><![endif]--><sup><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">[44]<!-- [if gte mso 9]><xml> <w:data>08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000D0000005F00520065006600360039003300390033003400300036000000</w:data> </xml><![endif]--></span></sup><!-- [if supportFields]><sup><span style='mso-ascii-font-family:Cambria;mso-hansi-font-family:Cambria'><span style='mso-element:field-end'></span></span></sup><![endif]--><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">, which are given in ISO 80601-2-87.</span></p> <p class="Note" style="margin-left: 18.9pt; tab-stops: 63.8pt;"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">NOTE</span><span lang="EN-GB"> 6<span style="mso-tab-count: 1;">      </span>An <em style="mso-bidi-font-style: normal;">EMS</em> <em style="mso-bidi-font-style: normal;">ventilator</em> can incorporate high-frequency jet or high-frequency oscillatory <em style="mso-bidi-font-style: normal;">ventilation-modes</em>.</span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">respiratory high-flow therapy equipment, which are given in ISO 80601-2-90.</span></p> <p class="Note" style="margin-left: 18.9pt; tab-stops: 63.8pt;"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">NOTE</span><span lang="EN-GB"> 7<span style="mso-tab-count: 1;">      </span>An <em style="mso-bidi-font-style: normal;">EMS</em> <em style="mso-bidi-font-style: normal;">ventilator</em> can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing <em>patients</em>.</span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">oxygen therapy constant flow <em>ME equipment</em>.</span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria;">cuirass or “iron‐lung” <em style="mso-bidi-font-style: normal;">ventilators</em>.</span></p>
StatussStandarts spēkā
ICS grupa11.040.10