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<p>This document applies to the <i>basic safety</i> and <i>essential performance</i> of an <i>EMS</i> <i>ventilator</i> in combination with its <i>accessories</i>, hereafter also referred to as <i>ME equipment:</i> </p>
<ul>
<li> intended for <i>patients</i> who need differing levels of support from artificial ventilation including <i>ventilator-dependent</i> <i>patients</i>;</li>
<li> intended to be operated by a <i>healthcare professional operator</i>;</li>
<li> intended for use in the <i>EMS environment</i>; and</li>
<li> intended for invasive or non-invasive ventilation.</li>
</ul>
<p>NOTE 1 An <i>EMS</i> <i>ventilator </i>can also be used for transport within a <i>professional healthcare facility</i>.</p>
<p>* An <i>EMS ventilator</i> is not considered to utilize a <i>physiologic closed loop-control system</i> unless it uses a physiological <i>patient</i> variable to adjust the ventilation therapy settings.</p>
<p>This document is also applicable to those <i>accessories</i> intended by their <i>manufacturer</i> to be connected to the <i>ventilator</i> <i>breathing system</i>, or to an <i>EMS</i> <i>ventilator</i>, where the characteristics of those <i>accessories</i> can affect the <i>basic safety</i> or <i>essential performance</i> of the <i>EMS</i> <i>ventilator</i>. </p>
<p>NOTE 2 If a clause or subclause is specifically intended to be applicable to <i>ME equipment</i> only, or to <i>ME systems</i> 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 <i>ME equipment</i> and to <i>ME systems</i>, as relevant.</p>
<p><i>Hazards</i> inherent in the intended physiological function of <i>ME equipment</i> or <i>ME systems</i> within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005, 7.2.13 and 8.4.1.</p>
<p>NOTE 3 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.</p>
<p>This document does not specify the requirements for the following:</p>
<ul>
<li> <i>ventilators</i> or <i>accessories</i> intended for <i>ventilator-dependent</i> <i>patients</i> in critical care applications, which are given in ISO 80601-2-12. </li>
<li> <i>ventilators</i> or <i>accessories</i> intended for<i> ventilator-dependent patients</i> in the <i>home healthcare environment</i>, which are given in ISO 80601-2-72<sup>[3]</sup>. </li>
<li> <i>ventilators</i> or <i>accessories</i> intended for anaesthetic applications, which are given in ISO 80601‐2‐13<sup>[4]</sup>. </li>
<li> <i>ventilators</i> or <i>accessories</i> intended for ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing <i>patients</i>), which are given in ISO 80601‑2-79<sup>[5]</sup> and ISO 80601-2-80<sup>[6]</sup><sup> <sup>[1]</sup></sup>. </li>
<li> obstructive sleep apnoea therapy <i>ME equipment</i>, which are given in ISO 80601‐2‐70<sup>[7]</sup>. </li>
<li> <i>operator</i>-powered resuscitators, which are given in ISO 10651‐4<sup>[8]</sup>. </li>
<li> gas-powered emergency resuscitators, which are given in ISO 10651‐5<sup>[9]</sup>. </li>
<li> <i>continuous positive airway pressure</i> (<i>CPAP</i>) <i>ME equipment</i> .</li>
<li> high‐frequency jet <i>ventilators</i> (HFJVs), which are given in ISO 80601-2-87<sup>[11]</sup>.</li>
<li> high‐frequency oscillatory <i>ventilators</i> (HFOVs)<sup>[10]</sup>, which are given in ISO 80601-2-87<sup>[11]</sup>.</li>
</ul>
<p>NOTE 4 An <i>EMS</i> <i>ventilator</i> can incorporate high-frequency jet or high-frequency oscillatory <i>ventilation-modes</i>.</p>
<ul>
<li> cuirass or "iron‐lung" <i>ventilators</i>.</li>
</ul>
<p><sup><sup>[1]</sup></sup> ISO 80601-2-79 and ISO 80601-2-80 replace ISO 10651-6, which has been withdrawn.</p>
Reģistrācijas numurs (WIID)
72441
Darbības sfēra
<p>This document applies to the <i>basic safety</i> and <i>essential performance</i> of an <i>EMS</i> <i>ventilator</i> in combination with its <i>accessories</i>, hereafter also referred to as <i>ME equipment:</i> </p>
<ul>
<li> intended for <i>patients</i> who need differing levels of support from artificial ventilation including <i>ventilator-dependent</i> <i>patients</i>;</li>
<li> intended to be operated by a <i>healthcare professional operator</i>;</li>
<li> intended for use in the <i>EMS environment</i>; and</li>
<li> intended for invasive or non-invasive ventilation.</li>
</ul>
<p>NOTE 1 An <i>EMS</i> <i>ventilator </i>can also be used for transport within a <i>professional healthcare facility</i>.</p>
<p>* An <i>EMS ventilator</i> is not considered to utilize a <i>physiologic closed loop-control system</i> unless it uses a physiological <i>patient</i> variable to adjust the ventilation therapy settings.</p>
<p>This document is also applicable to those <i>accessories</i> intended by their <i>manufacturer</i> to be connected to the <i>ventilator</i> <i>breathing system</i>, or to an <i>EMS</i> <i>ventilator</i>, where the characteristics of those <i>accessories</i> can affect the <i>basic safety</i> or <i>essential performance</i> of the <i>EMS</i> <i>ventilator</i>. </p>
<p>NOTE 2 If a clause or subclause is specifically intended to be applicable to <i>ME equipment</i> only, or to <i>ME systems</i> 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 <i>ME equipment</i> and to <i>ME systems</i>, as relevant.</p>
<p><i>Hazards</i> inherent in the intended physiological function of <i>ME equipment</i> or <i>ME systems</i> within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005, 7.2.13 and 8.4.1.</p>
<p>NOTE 3 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.</p>
<p>This document does not specify the requirements for the following:</p>
<ul>
<li> <i>ventilators</i> or <i>accessories</i> intended for <i>ventilator-dependent</i> <i>patients</i> in critical care applications, which are given in ISO 80601-2-12. </li>
<li> <i>ventilators</i> or <i>accessories</i> intended for<i> ventilator-dependent patients</i> in the <i>home healthcare environment</i>, which are given in ISO 80601-2-72<sup>[3]</sup>. </li>
<li> <i>ventilators</i> or <i>accessories</i> intended for anaesthetic applications, which are given in ISO 80601‐2‐13<sup>[4]</sup>. </li>
<li> <i>ventilators</i> or <i>accessories</i> intended for ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing <i>patients</i>), which are given in ISO 80601‑2-79<sup>[5]</sup> and ISO 80601-2-80<sup>[6]</sup><sup> <sup>[1]</sup></sup>. </li>
<li> obstructive sleep apnoea therapy <i>ME equipment</i>, which are given in ISO 80601‐2‐70<sup>[7]</sup>. </li>
<li> <i>operator</i>-powered resuscitators, which are given in ISO 10651‐4<sup>[8]</sup>. </li>
<li> gas-powered emergency resuscitators, which are given in ISO 10651‐5<sup>[9]</sup>. </li>
<li> <i>continuous positive airway pressure</i> (<i>CPAP</i>) <i>ME equipment</i> .</li>
<li> high‐frequency jet <i>ventilators</i> (HFJVs), which are given in ISO 80601-2-87<sup>[11]</sup>.</li>
<li> high‐frequency oscillatory <i>ventilators</i> (HFOVs)<sup>[10]</sup>, which are given in ISO 80601-2-87<sup>[11]</sup>.</li>
</ul>
<p>NOTE 4 An <i>EMS</i> <i>ventilator</i> can incorporate high-frequency jet or high-frequency oscillatory <i>ventilation-modes</i>.</p>
<ul>
<li> cuirass or "iron‐lung" <i>ventilators</i>.</li>
</ul>
<p><sup><sup>[1]</sup></sup> ISO 80601-2-79 and ISO 80601-2-80 replace ISO 10651-6, which has been withdrawn.</p>
