| Nosaukums | <p class="Note"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">NOTE 1<span style="mso-tab-count: 1;"> </span>There is guidance or rationale for this subclause contained in Clause AA.2.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">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 <em style="mso-bidi-font-style: normal;">ventilatory support equipment,</em> as defined in </span><span class="citesec"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; color: black; mso-themecolor: text1;">201.3.302</span></span><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">, for <em style="mso-bidi-font-style: normal;">ventilatory insufficiency</em>, as defined in 201.3.302, hereafter also referred to as <em style="mso-bidi-font-style: normal;">ME equipment,</em> in combination with its <em style="mso-bidi-font-style: normal;">accessories</em>:</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span>intended for use in the <em style="mso-bidi-font-style: normal;">home healthcare environment</em>;</span></p>
<p class="Note" style="margin-left: 21.3pt; tab-stops: 63.8pt;"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">NOTE 2<span style="mso-tab-count: 1;"> </span>In the <em style="mso-bidi-font-style: normal;">home healthcare environment</em>, the <em style="mso-bidi-font-style: normal;">supply mains</em> driving the <em style="mso-bidi-font-style: normal;">ventilatory support equipment</em> is often not reliable.</span></p>
<p class="Note" style="margin-left: 21.3pt; tab-stops: 63.8pt;"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">NOTE 3<span style="mso-tab-count: 1;"> </span>Such <em style="mso-bidi-font-style: normal;">ventilatory support equipment</em> can also be used in <em>professional health care facilities</em>.</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span>intended for use by a <em style="mso-bidi-font-style: normal;">lay operator</em>;</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span>intended for use with <em style="mso-bidi-font-style: normal;">patients</em> who have <em style="mso-bidi-font-style: normal;">ventilatory insufficiency</em> or failure, the most fragile of which would likely experience injury with the loss of this <em>artificial ventilation</em>;</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span>intended for <em style="mso-bidi-font-style: normal;">transit-operable</em> use; and</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span>not intended for <em style="mso-bidi-font-style: normal;">patients</em> who are dependent on <em>artificial ventilation </em>for their immediate life support.</span></p>
<p class="Example" style="line-height: 12.0pt; tab-stops: 42.55pt 67.7pt; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">EXAMPLE 1<span style="mso-tab-count: 1;"> </span><em style="mso-bidi-font-style: normal;">Patients</em> with moderate to severe chronic obstructive pulmonary disease (COPD), moderate amyotrophic lateral sclerosis (ALS), severe bronchopulmonary dysplasia or muscular dystrophy.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><em style="mso-bidi-font-style: normal;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">Ventilatory support equipment</span></em><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS'; color: black; mso-themecolor: text1;"> 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="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">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 the <em style="mso-bidi-font-style: normal;">ventilator breathing system</em> of <em style="mso-bidi-font-style: normal;">ventilatory support equipment</em> for <em style="mso-bidi-font-style: normal;">ventilatory insufficiency</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;">ventilatory support equipment </em>for <em style="mso-bidi-font-style: normal;">ventilatory insufficiency</em>.</span></p>
<p class="Example" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">EXAMPLE 2<span style="mso-tab-count: 1;"> </span>Breathing sets, <em>connectors</em>, water traps, expiratory valve, <em style="mso-bidi-font-style: normal;">humidifier</em>, <em style="mso-bidi-font-style: normal;">breathing system filter</em>, external electrical power source, <em style="mso-bidi-font-style: normal;">distributed alarm system</em>.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">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="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><em style="mso-bidi-font-style: normal;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">Hazards</span></em><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;"> 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 class="stdpublisher"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; color: black; mso-themecolor: text1;">IEC</span></span><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;"> <span class="stddocNumber">60601</span>‑<span class="stddocPartNumber">1</span>:<span class="stdyear">2005</span><span class="stdsuppl">+AMD1:2012+AMD2:2020</span>, <span class="stdsection">7.2.13 and 8.4.1</span>.</span></p>
<p class="Note"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">NOTE 4<span style="mso-tab-count: 1;"> </span>Additional information can be found in </span><span class="stdpublisher"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; color: black; mso-themecolor: text1;">IEC</span></span><span lang="EN-GB" style="color: black; mso-themecolor: text1;"> </span><span class="stddocNumber"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">60601</span></span><span lang="EN-GB" style="color: black; mso-themecolor: text1;">‑</span><span class="stddocPartNumber"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">1</span></span><span lang="EN-GB" style="color: black; mso-themecolor: text1;">:</span><span class="stdyear"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">2005</span></span><span class="stdsuppl"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">+AMD1:2012+AMD2:2020</span></span><span lang="EN-GB" style="color: black; mso-themecolor: text1;">, </span><span class="stdsection"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">4.2</span></span><span lang="EN-GB" style="color: black; mso-themecolor: text1;">.</span></p>
<p class="Note"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">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="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">This document does not specify the requirements for:</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span><em style="mso-bidi-font-style: normal;">ventilators</em> or <em style="mso-bidi-font-style: normal;">accessories</em> for <em style="mso-bidi-font-style: normal;">ventilator-dependent patients</em> intended for critical care applications, which are given in <span class="stdpublisher">ISO</span> <span class="stddocNumber">80601</span>‑<span class="stddocPartNumber">2‑12</span>;</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span><em style="mso-bidi-font-style: normal;">ventilators</em> or <em style="mso-bidi-font-style: normal;">accessories</em> intended for anaesthetic applications, which are given in <span class="stdpublisher">ISO</span> <span class="stddocNumber">80601</span>‑<span class="stddocPartNumber">2‑13</span>;</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span><em style="mso-bidi-font-style: normal;">ventilators</em> or <em style="mso-bidi-font-style: normal;">accessories</em> intended for the emergency medical services environment, which are given in <span class="stdpublisher">ISO</span> <span class="stddocNumber">80601</span>‑<span class="stddocPartNumber">2‑84</span>;</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span><em>ventilators</em> or <em>accessories</em> intended for <em>ventilator-dependent patients</em> in the <em>home healthcare environment</em>, which are given in <span class="stdpublisher">ISO</span> <span class="stddocNumber">80601</span>‑<span class="stddocPartNumber">2‑72</span>;</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span><em style="mso-bidi-font-style: normal;">ventilatory support equipment</em> or <em style="mso-bidi-font-style: normal;">accessories</em> intended for <em style="mso-bidi-font-style: normal;">ventilatory impairment</em>, which are given in <span class="stdpublisher">ISO</span> <span class="stddocNumber">80601</span>‑<span class="stddocPartNumber">2‑79</span>;</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span>sleep apnoea therapy <em style="mso-bidi-font-style: normal;">ME equipment</em>, which are given in <span class="stdpublisher">ISO</span> <span class="stddocNumber">80601</span>‑<span class="stddocPartNumber">2‑70</span>;</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span>high-frequency jet <em style="mso-bidi-font-style: normal;">ventilators</em> (HFJVs), </span><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS'; color: black; mso-themecolor: text1;">which</span><span lang="EN-GB" style="color: black; mso-themecolor: text1;"> are given in ISO 80601‑2‑87;</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span>high-frequency oscillatory <em style="mso-bidi-font-style: normal;">ventilators</em> (HFOVs)</span><span lang="EN-GB" style="color: black; mso-themecolor: text1;">;</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span>respiratory high flow<em style="mso-bidi-font-style: normal;"> </em><span style="mso-bidi-font-style: italic;">equipment</span>, which are given in <span class="stdpublisher">ISO</span> <span class="stddocNumber">80601</span>‑<span class="stddocPartNumber">2‑90</span><em style="mso-bidi-font-style: normal;">;</em></span></p>
<p class="Note" style="margin-left: 19.6pt; tab-stops: 63.8pt;"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">NOTE 6<span style="mso-tab-count: 1;"> </span><em style="mso-bidi-font-style: normal;">Ventilatory support equipment</em> can incorporate high-flow therapy <span style="mso-bidi-font-style: italic;">operational mode, but such a mode is only for spontaneously breathing </span><em style="mso-bidi-font-style: normal;">patients</em>.</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS'; color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span>user-powered resuscitators, which are given in ISO 10651-4;</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS'; color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span>gas-powered emergency resuscitators, which are given in ISO 10651-5;</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS'; color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span>oxygen</span><span lang="EN-GB" style="color: black; mso-themecolor: text1;"> therapy constant flow <em style="mso-bidi-font-style: normal;">ME equipment</em>; and</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span>cuirass or “iron-lung” <em>ventilation</em> equipment.</span></p> |
|---|
| Darbības sfēra | <p class="Note"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">NOTE 1<span style="mso-tab-count: 1;"> </span>There is guidance or rationale for this subclause contained in Clause AA.2.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">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 <em style="mso-bidi-font-style: normal;">ventilatory support equipment,</em> as defined in </span><span class="citesec"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; color: black; mso-themecolor: text1;">201.3.302</span></span><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">, for <em style="mso-bidi-font-style: normal;">ventilatory insufficiency</em>, as defined in 201.3.302, hereafter also referred to as <em style="mso-bidi-font-style: normal;">ME equipment,</em> in combination with its <em style="mso-bidi-font-style: normal;">accessories</em>:</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span>intended for use in the <em style="mso-bidi-font-style: normal;">home healthcare environment</em>;</span></p>
<p class="Note" style="margin-left: 21.3pt; tab-stops: 63.8pt;"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">NOTE 2<span style="mso-tab-count: 1;"> </span>In the <em style="mso-bidi-font-style: normal;">home healthcare environment</em>, the <em style="mso-bidi-font-style: normal;">supply mains</em> driving the <em style="mso-bidi-font-style: normal;">ventilatory support equipment</em> is often not reliable.</span></p>
<p class="Note" style="margin-left: 21.3pt; tab-stops: 63.8pt;"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">NOTE 3<span style="mso-tab-count: 1;"> </span>Such <em style="mso-bidi-font-style: normal;">ventilatory support equipment</em> can also be used in <em>professional health care facilities</em>.</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span>intended for use by a <em style="mso-bidi-font-style: normal;">lay operator</em>;</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span>intended for use with <em style="mso-bidi-font-style: normal;">patients</em> who have <em style="mso-bidi-font-style: normal;">ventilatory insufficiency</em> or failure, the most fragile of which would likely experience injury with the loss of this <em>artificial ventilation</em>;</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span>intended for <em style="mso-bidi-font-style: normal;">transit-operable</em> use; and</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span>not intended for <em style="mso-bidi-font-style: normal;">patients</em> who are dependent on <em>artificial ventilation </em>for their immediate life support.</span></p>
<p class="Example" style="line-height: 12.0pt; tab-stops: 42.55pt 67.7pt; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">EXAMPLE 1<span style="mso-tab-count: 1;"> </span><em style="mso-bidi-font-style: normal;">Patients</em> with moderate to severe chronic obstructive pulmonary disease (COPD), moderate amyotrophic lateral sclerosis (ALS), severe bronchopulmonary dysplasia or muscular dystrophy.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><em style="mso-bidi-font-style: normal;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">Ventilatory support equipment</span></em><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS'; color: black; mso-themecolor: text1;"> 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="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">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 the <em style="mso-bidi-font-style: normal;">ventilator breathing system</em> of <em style="mso-bidi-font-style: normal;">ventilatory support equipment</em> for <em style="mso-bidi-font-style: normal;">ventilatory insufficiency</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;">ventilatory support equipment </em>for <em style="mso-bidi-font-style: normal;">ventilatory insufficiency</em>.</span></p>
<p class="Example" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">EXAMPLE 2<span style="mso-tab-count: 1;"> </span>Breathing sets, <em>connectors</em>, water traps, expiratory valve, <em style="mso-bidi-font-style: normal;">humidifier</em>, <em style="mso-bidi-font-style: normal;">breathing system filter</em>, external electrical power source, <em style="mso-bidi-font-style: normal;">distributed alarm system</em>.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">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="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><em style="mso-bidi-font-style: normal;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">Hazards</span></em><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;"> 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 class="stdpublisher"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; color: black; mso-themecolor: text1;">IEC</span></span><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;"> <span class="stddocNumber">60601</span>‑<span class="stddocPartNumber">1</span>:<span class="stdyear">2005</span><span class="stdsuppl">+AMD1:2012+AMD2:2020</span>, <span class="stdsection">7.2.13 and 8.4.1</span>.</span></p>
<p class="Note"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">NOTE 4<span style="mso-tab-count: 1;"> </span>Additional information can be found in </span><span class="stdpublisher"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; color: black; mso-themecolor: text1;">IEC</span></span><span lang="EN-GB" style="color: black; mso-themecolor: text1;"> </span><span class="stddocNumber"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">60601</span></span><span lang="EN-GB" style="color: black; mso-themecolor: text1;">‑</span><span class="stddocPartNumber"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">1</span></span><span lang="EN-GB" style="color: black; mso-themecolor: text1;">:</span><span class="stdyear"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">2005</span></span><span class="stdsuppl"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">+AMD1:2012+AMD2:2020</span></span><span lang="EN-GB" style="color: black; mso-themecolor: text1;">, </span><span class="stdsection"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">4.2</span></span><span lang="EN-GB" style="color: black; mso-themecolor: text1;">.</span></p>
<p class="Note"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">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="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; color: black; mso-themecolor: text1;">This document does not specify the requirements for:</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span><em style="mso-bidi-font-style: normal;">ventilators</em> or <em style="mso-bidi-font-style: normal;">accessories</em> for <em style="mso-bidi-font-style: normal;">ventilator-dependent patients</em> intended for critical care applications, which are given in <span class="stdpublisher">ISO</span> <span class="stddocNumber">80601</span>‑<span class="stddocPartNumber">2‑12</span>;</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span><em style="mso-bidi-font-style: normal;">ventilators</em> or <em style="mso-bidi-font-style: normal;">accessories</em> intended for anaesthetic applications, which are given in <span class="stdpublisher">ISO</span> <span class="stddocNumber">80601</span>‑<span class="stddocPartNumber">2‑13</span>;</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span><em style="mso-bidi-font-style: normal;">ventilators</em> or <em style="mso-bidi-font-style: normal;">accessories</em> intended for the emergency medical services environment, which are given in <span class="stdpublisher">ISO</span> <span class="stddocNumber">80601</span>‑<span class="stddocPartNumber">2‑84</span>;</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span><em>ventilators</em> or <em>accessories</em> intended for <em>ventilator-dependent patients</em> in the <em>home healthcare environment</em>, which are given in <span class="stdpublisher">ISO</span> <span class="stddocNumber">80601</span>‑<span class="stddocPartNumber">2‑72</span>;</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span><em style="mso-bidi-font-style: normal;">ventilatory support equipment</em> or <em style="mso-bidi-font-style: normal;">accessories</em> intended for <em style="mso-bidi-font-style: normal;">ventilatory impairment</em>, which are given in <span class="stdpublisher">ISO</span> <span class="stddocNumber">80601</span>‑<span class="stddocPartNumber">2‑79</span>;</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span>sleep apnoea therapy <em style="mso-bidi-font-style: normal;">ME equipment</em>, which are given in <span class="stdpublisher">ISO</span> <span class="stddocNumber">80601</span>‑<span class="stddocPartNumber">2‑70</span>;</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span>high-frequency jet <em style="mso-bidi-font-style: normal;">ventilators</em> (HFJVs), </span><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS'; color: black; mso-themecolor: text1;">which</span><span lang="EN-GB" style="color: black; mso-themecolor: text1;"> are given in ISO 80601‑2‑87;</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span>high-frequency oscillatory <em style="mso-bidi-font-style: normal;">ventilators</em> (HFOVs)</span><span lang="EN-GB" style="color: black; mso-themecolor: text1;">;</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span>respiratory high flow<em style="mso-bidi-font-style: normal;"> </em><span style="mso-bidi-font-style: italic;">equipment</span>, which are given in <span class="stdpublisher">ISO</span> <span class="stddocNumber">80601</span>‑<span class="stddocPartNumber">2‑90</span><em style="mso-bidi-font-style: normal;">;</em></span></p>
<p class="Note" style="margin-left: 19.6pt; tab-stops: 63.8pt;"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">NOTE 6<span style="mso-tab-count: 1;"> </span><em style="mso-bidi-font-style: normal;">Ventilatory support equipment</em> can incorporate high-flow therapy <span style="mso-bidi-font-style: italic;">operational mode, but such a mode is only for spontaneously breathing </span><em style="mso-bidi-font-style: normal;">patients</em>.</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS'; color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span>user-powered resuscitators, which are given in ISO 10651-4;</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS'; color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span>gas-powered emergency resuscitators, which are given in ISO 10651-5;</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS'; color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span>oxygen</span><span lang="EN-GB" style="color: black; mso-themecolor: text1;"> therapy constant flow <em style="mso-bidi-font-style: normal;">ME equipment</em>; and</span></p>
<p class="ListContinue1"><span lang="EN-GB" style="color: black; mso-themecolor: text1;">—<span style="mso-tab-count: 1;"> </span>cuirass or “iron-lung” <em>ventilation</em> equipment.</span></p> |
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