ISO/TC 121/SC 3/JWG 1

Project No.ISO 80601-2-12:2023
Title<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 document 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 a critical care <em style="mso-bidi-font-style: normal;">ventilator</em> in combination with its <em style="mso-bidi-font-style: normal;">accessories</em>, hereafter 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 lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; letter-spacing: 0pt; mso-ansi-language: EN-GB; mso-bidi-font-style: italic;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">intended for use in an environment that provides specialized care for <em style="mso-bidi-font-style: normal;">patients</em> whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a <em style="mso-bidi-font-style: normal;">professional healthcare facility;</em> </span></p> <p class="Note" style="margin-left: 20.0pt; tab-stops: 42.55pt 65.0pt;"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">NOTE 2</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 lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">For the purposes of this document, such an environment is referred to as a critical </span><span lang="EN-GB" style="mso-bidi-font-size: 9.0pt; line-height: 115%; mso-fareast-font-family: 'Arial Unicode MS';">care environment</span><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">. <em style="mso-bidi-font-style: normal;">Ventilators</em> for this environment are considered life-sustaining. </span></p> <p class="Note" style="margin-left: 20.0pt; tab-stops: 42.55pt 65.0pt;"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">NOTE 3</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 lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">For the purposes of this document, such a critical care <em style="mso-bidi-font-style: normal;">ventilator</em> can provide ventilation during </span><span lang="EN-GB">transport within a <em style="mso-bidi-font-style: normal;">professional healthcare facility</em> (i.e. be a <em style="mso-bidi-font-style: normal;">transit-operable</em> <em style="mso-bidi-font-style: normal;">ventilator</em>).<span style="mso-bidi-font-style: italic;"> </span></span></p> <p class="Note" style="margin-left: 20.0pt; tab-stops: 42.55pt 65.0pt;"><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 lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">A critical </span><span lang="EN-GB" style="mso-bidi-font-size: 9.0pt; line-height: 115%; mso-fareast-font-family: 'Arial Unicode MS';">care <em style="mso-bidi-font-style: normal;">ventilator</em> intended</span><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';"> for use in transport within a <em style="mso-bidi-font-style: normal;">professional healthcare facility</em> is not considered as an <em style="mso-bidi-font-style: normal;">emergency medical services environment</em> <em style="mso-bidi-font-style: normal;">ventilator</em>.</span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; letter-spacing: 0pt; mso-ansi-language: EN-GB;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">intended to be operated by a <em style="mso-bidi-font-style: normal;">healthcare professional</em> <em style="mso-bidi-font-style: normal;">operator</em>; and </span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; letter-spacing: 0pt; mso-ansi-language: EN-GB;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">intended for those <em style="mso-bidi-font-style: normal;">patients</em> who need differing levels of support from <em>artificial ventilation </em>including for <em style="mso-bidi-font-style: normal;">ventilator-dependent patients</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;">A critical care <em style="mso-bidi-font-style: normal;">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 document 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 a <em style="mso-bidi-font-style: normal;">ventilator breathing system</em>, or to a <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;">ventilator</em>. </span></p> <p class="Note"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">NOTE 5</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 lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">If a </span><span lang="EN-GB">clause</span><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';"> 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</span><span lang="EN-GB">+AMD1:2012</span><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; mso-fareast-language: EN-US;">+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 6</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 lang="EN-GB" style="mso-bidi-font-family: Arial;">Additional information can be found in IEC 60601-1:2005+AMD1:2012</span><span lang="EN-GB">+AMD2:2020</span><span lang="EN-GB" style="mso-bidi-font-family: Arial;">, 4.2.</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 style="mso-bidi-font-style: italic;"> document is not applicable to </span><em style="mso-bidi-font-style: normal;">ME equipment</em> or an <em style="mso-bidi-font-style: normal;">ME system</em> operating in a <em style="mso-bidi-font-style: normal;">ventilator-operational mode</em> solely intended for <em style="mso-bidi-font-style: normal;">patients</em> who are not dependent on <em>artificial ventilation</em>. </span></p> <p class="Note"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">NOTE 7</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 lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">A critical </span><span lang="EN-GB" style="mso-bidi-font-size: 9.0pt; line-height: 115%; mso-fareast-font-family: 'Arial Unicode MS';">care <em style="mso-bidi-font-style: normal;">ventilator</em></span><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">, when operating in such a <em style="mso-bidi-font-style: normal;">ventilator-operational mode</em>, is not considered life-sustaining<em style="mso-bidi-font-style: normal;">.</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;">This document is not applicable to <em style="mso-bidi-font-style: normal;">ME equipment</em> that is intended solely to augment the ventilation<em> </em>of spontaneously breathing <em style="mso-bidi-font-style: normal;">patients</em> 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; mso-bidi-font-style: italic;">This</span><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria;"> </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;"> does not specify the requirements for: </span></p> <p class="Note"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">NOTE</span><span lang="EN-GB"> 8<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></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; letter-spacing: 0pt; mso-ansi-language: EN-GB;"><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 lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">ventilators</span></em><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;"> or <em style="mso-bidi-font-style: normal;">accessories</em> intended 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 lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; letter-spacing: 0pt; mso-ansi-language: EN-GB;"><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 lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">ventilators</span></em><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;"> or <em style="mso-bidi-font-style: normal;">accessories</em> intended for the <em style="mso-bidi-font-style: normal;">emergency medical services environment</em>, which are given in ISO 80601-2-84; </span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; letter-spacing: 0pt; mso-ansi-language: EN-GB;"><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 lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">ventilators</span></em><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;"> 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></span><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB; mso-no-proof: no;">in the <em style="mso-bidi-font-style: normal;">home healthcare environment</em></span><em style="mso-bidi-font-style: normal;"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">,</span></em><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;"> which are given in ISO 80601‑2-72; </span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; letter-spacing: 0pt; mso-ansi-language: EN-GB;"><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 lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">ventilators</span></em><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;"> or <em style="mso-bidi-font-style: normal;">accessories</em> intended for home-care ventilatory support devices, 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 lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; letter-spacing: 0pt; mso-ansi-language: EN-GB;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">obstructive sleep apnoea therapy <em style="mso-bidi-font-style: normal;">ME equipment</em>, </span><span style="mso-bookmark: _Ref392228033;"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">which</span></span><span style="mso-bookmark: _Ref392228033;"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;"> are given in ISO 80601‑2‑70; </span></span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><span style="mso-bookmark: _Ref392228033;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; letter-spacing: 0pt;"><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; letter-spacing: 0pt;">continuous positive airway pressure</span></em></span><span style="mso-bookmark: _Ref392228033;"><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; letter-spacing: 0pt;"> (<em>CPAP</em>) <em>ME equipment</em>.</span></span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><span style="mso-bookmark: _Ref392228033;"><!-- [if !supportLists]--><span lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; letter-spacing: 0pt; mso-ansi-language: EN-GB;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">high-</span></span><span style="mso-bookmark: _Ref392228033;"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">frequency</span></span><span style="mso-bookmark: _Ref392228033;"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;"> <em>ventilators</em>, which</span></span><span style="mso-bookmark: _Ref392228033;"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;"> are given in ISO 80601‑2‑87</span></span><span style="mso-bookmark: _Ref392228033;"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">; </span></span></p> <p class="Note" style="margin-left: 18.9pt; tab-stops: 63.8pt;"><span style="mso-bookmark: _Ref392228033;"><span lang="EN-GB">NOTE 9<span style="mso-tab-count: 1;">      </span>A critical care <em style="mso-bidi-font-style: normal;">ventilator</em> can incorporate high-frequency jet or high-frequency oscillatory </span></span><span style="mso-bookmark: _Ref392228033;"><em style="mso-bidi-font-style: normal;"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">ventilator-operational mode</span><span lang="EN-GB">s</span></em><span lang="EN-GB">.</span></span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><span style="mso-bookmark: _Ref392228033;"><!-- [if !supportLists]--><span lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; letter-spacing: 0pt; mso-ansi-language: EN-GB;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">respiratory high-</span></span><span style="mso-bookmark: _Ref392228033;"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">flow</span></span><span style="mso-bookmark: _Ref392228033;"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;"> therapy equipment, which</span></span><span style="mso-bookmark: _Ref392228033;"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;"> are given in ISO 80601‑2‑90</span></span><span style="mso-bookmark: _Ref392228033;"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">; </span></span></p> <p class="Note" style="margin-left: 18.9pt; tab-stops: 63.8pt;"><span style="mso-bookmark: _Ref392228033;"><span lang="EN-GB">NOTE 10<span style="mso-tab-count: 1;">    </span>A critical care <em style="mso-bidi-font-style: normal;">ventilator</em> can incorporate high-flow therapy </span></span><span style="mso-bookmark: _Ref392228033;"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS'; mso-bidi-font-style: italic;">operational mode, but such a mode is only for spontaneously breathing </span></span><span style="mso-bookmark: _Ref392228033;"><em style="mso-bidi-font-style: normal;"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">patients</span></em><span lang="EN-GB">.</span></span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><span style="mso-bookmark: _Ref392228033;"><!-- [if !supportLists]--><span lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; letter-spacing: 0pt; mso-ansi-language: EN-GB;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB; mso-no-proof: no;">oxygen therapy constant flow <em style="mso-bidi-font-style: normal;">ME equipment</em>; and</span></span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><span style="mso-bookmark: _Ref392228033;"><!-- [if !supportLists]--><span lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; letter-spacing: 0pt; mso-ansi-language: EN-GB;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB; mso-no-proof: no;">cuirass or “iron-lung” ventilation<em> </em>equipment. </span></span></p>
Registration number (WIID)82707
Scope<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 document 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 a critical care <em style="mso-bidi-font-style: normal;">ventilator</em> in combination with its <em style="mso-bidi-font-style: normal;">accessories</em>, hereafter 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 lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; letter-spacing: 0pt; mso-ansi-language: EN-GB; mso-bidi-font-style: italic;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">intended for use in an environment that provides specialized care for <em style="mso-bidi-font-style: normal;">patients</em> whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a <em style="mso-bidi-font-style: normal;">professional healthcare facility;</em> </span></p> <p class="Note" style="margin-left: 20.0pt; tab-stops: 42.55pt 65.0pt;"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">NOTE 2</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 lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">For the purposes of this document, such an environment is referred to as a critical </span><span lang="EN-GB" style="mso-bidi-font-size: 9.0pt; line-height: 115%; mso-fareast-font-family: 'Arial Unicode MS';">care environment</span><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">. <em style="mso-bidi-font-style: normal;">Ventilators</em> for this environment are considered life-sustaining. </span></p> <p class="Note" style="margin-left: 20.0pt; tab-stops: 42.55pt 65.0pt;"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">NOTE 3</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 lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">For the purposes of this document, such a critical care <em style="mso-bidi-font-style: normal;">ventilator</em> can provide ventilation during </span><span lang="EN-GB">transport within a <em style="mso-bidi-font-style: normal;">professional healthcare facility</em> (i.e. be a <em style="mso-bidi-font-style: normal;">transit-operable</em> <em style="mso-bidi-font-style: normal;">ventilator</em>).<span style="mso-bidi-font-style: italic;"> </span></span></p> <p class="Note" style="margin-left: 20.0pt; tab-stops: 42.55pt 65.0pt;"><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 lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">A critical </span><span lang="EN-GB" style="mso-bidi-font-size: 9.0pt; line-height: 115%; mso-fareast-font-family: 'Arial Unicode MS';">care <em style="mso-bidi-font-style: normal;">ventilator</em> intended</span><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';"> for use in transport within a <em style="mso-bidi-font-style: normal;">professional healthcare facility</em> is not considered as an <em style="mso-bidi-font-style: normal;">emergency medical services environment</em> <em style="mso-bidi-font-style: normal;">ventilator</em>.</span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; letter-spacing: 0pt; mso-ansi-language: EN-GB;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">intended to be operated by a <em style="mso-bidi-font-style: normal;">healthcare professional</em> <em style="mso-bidi-font-style: normal;">operator</em>; and </span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; letter-spacing: 0pt; mso-ansi-language: EN-GB;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">intended for those <em style="mso-bidi-font-style: normal;">patients</em> who need differing levels of support from <em>artificial ventilation </em>including for <em style="mso-bidi-font-style: normal;">ventilator-dependent patients</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;">A critical care <em style="mso-bidi-font-style: normal;">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 document 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 a <em style="mso-bidi-font-style: normal;">ventilator breathing system</em>, or to a <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;">ventilator</em>. </span></p> <p class="Note"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">NOTE 5</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 lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">If a </span><span lang="EN-GB">clause</span><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';"> 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</span><span lang="EN-GB">+AMD1:2012</span><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; mso-fareast-language: EN-US;">+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 6</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 lang="EN-GB" style="mso-bidi-font-family: Arial;">Additional information can be found in IEC 60601-1:2005+AMD1:2012</span><span lang="EN-GB">+AMD2:2020</span><span lang="EN-GB" style="mso-bidi-font-family: Arial;">, 4.2.</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 style="mso-bidi-font-style: italic;"> document is not applicable to </span><em style="mso-bidi-font-style: normal;">ME equipment</em> or an <em style="mso-bidi-font-style: normal;">ME system</em> operating in a <em style="mso-bidi-font-style: normal;">ventilator-operational mode</em> solely intended for <em style="mso-bidi-font-style: normal;">patients</em> who are not dependent on <em>artificial ventilation</em>. </span></p> <p class="Note"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">NOTE 7</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 lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">A critical </span><span lang="EN-GB" style="mso-bidi-font-size: 9.0pt; line-height: 115%; mso-fareast-font-family: 'Arial Unicode MS';">care <em style="mso-bidi-font-style: normal;">ventilator</em></span><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">, when operating in such a <em style="mso-bidi-font-style: normal;">ventilator-operational mode</em>, is not considered life-sustaining<em style="mso-bidi-font-style: normal;">.</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;">This document is not applicable to <em style="mso-bidi-font-style: normal;">ME equipment</em> that is intended solely to augment the ventilation<em> </em>of spontaneously breathing <em style="mso-bidi-font-style: normal;">patients</em> 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; mso-bidi-font-style: italic;">This</span><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria;"> </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;"> does not specify the requirements for: </span></p> <p class="Note"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">NOTE</span><span lang="EN-GB"> 8<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></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; letter-spacing: 0pt; mso-ansi-language: EN-GB;"><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 lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">ventilators</span></em><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;"> or <em style="mso-bidi-font-style: normal;">accessories</em> intended 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 lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; letter-spacing: 0pt; mso-ansi-language: EN-GB;"><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 lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">ventilators</span></em><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;"> or <em style="mso-bidi-font-style: normal;">accessories</em> intended for the <em style="mso-bidi-font-style: normal;">emergency medical services environment</em>, which are given in ISO 80601-2-84; </span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; letter-spacing: 0pt; mso-ansi-language: EN-GB;"><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 lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">ventilators</span></em><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;"> 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></span><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB; mso-no-proof: no;">in the <em style="mso-bidi-font-style: normal;">home healthcare environment</em></span><em style="mso-bidi-font-style: normal;"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">,</span></em><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;"> which are given in ISO 80601‑2-72; </span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; letter-spacing: 0pt; mso-ansi-language: EN-GB;"><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 lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">ventilators</span></em><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;"> or <em style="mso-bidi-font-style: normal;">accessories</em> intended for home-care ventilatory support devices, 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 lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; letter-spacing: 0pt; mso-ansi-language: EN-GB;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">obstructive sleep apnoea therapy <em style="mso-bidi-font-style: normal;">ME equipment</em>, </span><span style="mso-bookmark: _Ref392228033;"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">which</span></span><span style="mso-bookmark: _Ref392228033;"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;"> are given in ISO 80601‑2‑70; </span></span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><span style="mso-bookmark: _Ref392228033;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; letter-spacing: 0pt;"><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; letter-spacing: 0pt;">continuous positive airway pressure</span></em></span><span style="mso-bookmark: _Ref392228033;"><span style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; letter-spacing: 0pt;"> (<em>CPAP</em>) <em>ME equipment</em>.</span></span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><span style="mso-bookmark: _Ref392228033;"><!-- [if !supportLists]--><span lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; letter-spacing: 0pt; mso-ansi-language: EN-GB;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">high-</span></span><span style="mso-bookmark: _Ref392228033;"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">frequency</span></span><span style="mso-bookmark: _Ref392228033;"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;"> <em>ventilators</em>, which</span></span><span style="mso-bookmark: _Ref392228033;"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;"> are given in ISO 80601‑2‑87</span></span><span style="mso-bookmark: _Ref392228033;"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">; </span></span></p> <p class="Note" style="margin-left: 18.9pt; tab-stops: 63.8pt;"><span style="mso-bookmark: _Ref392228033;"><span lang="EN-GB">NOTE 9<span style="mso-tab-count: 1;">      </span>A critical care <em style="mso-bidi-font-style: normal;">ventilator</em> can incorporate high-frequency jet or high-frequency oscillatory </span></span><span style="mso-bookmark: _Ref392228033;"><em style="mso-bidi-font-style: normal;"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">ventilator-operational mode</span><span lang="EN-GB">s</span></em><span lang="EN-GB">.</span></span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><span style="mso-bookmark: _Ref392228033;"><!-- [if !supportLists]--><span lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; letter-spacing: 0pt; mso-ansi-language: EN-GB;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">respiratory high-</span></span><span style="mso-bookmark: _Ref392228033;"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">flow</span></span><span style="mso-bookmark: _Ref392228033;"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;"> therapy equipment, which</span></span><span style="mso-bookmark: _Ref392228033;"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;"> are given in ISO 80601‑2‑90</span></span><span style="mso-bookmark: _Ref392228033;"><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB;">; </span></span></p> <p class="Note" style="margin-left: 18.9pt; tab-stops: 63.8pt;"><span style="mso-bookmark: _Ref392228033;"><span lang="EN-GB">NOTE 10<span style="mso-tab-count: 1;">    </span>A critical care <em style="mso-bidi-font-style: normal;">ventilator</em> can incorporate high-flow therapy </span></span><span style="mso-bookmark: _Ref392228033;"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS'; mso-bidi-font-style: italic;">operational mode, but such a mode is only for spontaneously breathing </span></span><span style="mso-bookmark: _Ref392228033;"><em style="mso-bidi-font-style: normal;"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">patients</span></em><span lang="EN-GB">.</span></span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><span style="mso-bookmark: _Ref392228033;"><!-- [if !supportLists]--><span lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; letter-spacing: 0pt; mso-ansi-language: EN-GB;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB; mso-no-proof: no;">oxygen therapy constant flow <em style="mso-bidi-font-style: normal;">ME equipment</em>; and</span></span></p> <p class="MsoListContinue" style="mso-list: l0 level1 lfo1;"><span style="mso-bookmark: _Ref392228033;"><!-- [if !supportLists]--><span lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; letter-spacing: 0pt; mso-ansi-language: EN-GB;"><span style="mso-list: Ignore;">¾<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB" style="mso-ascii-font-family: Cambria; mso-hansi-font-family: Cambria; letter-spacing: 0pt; mso-ansi-language: EN-GB; mso-no-proof: no;">cuirass or “iron-lung” ventilation<em> </em>equipment. </span></span></p>
StatusStandarts spēkā
ICS group11.040.10