Informējam, ka Sistēma pielāgota darbam ar interneta pārlūkprogrammu Internet Explorer (8. un jaunākām versijām) un Mozilla Firefox (3.6 un jaunākām versijām).
Izmantojot citu interneta pārlūkprogrammu, brīdinām, ka Sistēmas funkcionalitāte var tikt traucēta.
<p>This document applies to the <em>basic safety</em> and <em>essential performance</em> of a <em>high-frequency</em> <em>ventilator</em> (<em>HFV</em>) in combination with its <em>accessories</em>, hereafter referred to as <em>ME equipment:</em></p>
<ul>
<li>intended for use in an environment that provides specialized care for <em>patients</em> whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a <em>professional healthcare facility;</em></li>
</ul>
<p>NOTE 1 For the purposes of this document, such an environment is referred to as a critical care environment. <em>High-frequency</em><em> </em><em>ventilators</em> for this environment are considered life-sustaining.</p>
<p>NOTE 2 For the purposes of this document, such a <em>high-frequency</em><em> </em><em>ventilator</em> can provide transport within a <em>professional healthcare facility</em> (i.e., be a <em>transit-operable</em> <em>ventilator</em>).</p>
<p>NOTE 3 A <em>high-frequency</em><em> ventilator</em> intended for use in transport within a <em>professional healthcare facility</em> is not considered as a <em>ventilator</em> intended for the <em>emergency medical services environment</em>.</p>
<ul>
<li>intended to be operated by a <em>healthcare professional</em> <em>operator</em>;</li>
<li>intended for those <em>patients</em> who need differing levels of support from <em>artificial ventilation</em> including <em>ventilator-dependent patients; </em>and</li>
<li>capable of providing more than 150 <em>inflations</em>/min.</li>
</ul>
<p>There are three principal designations of <em>HFV</em>:</p>
<ul>
<li>high-frequency percussive <em>ventilation</em> [HFPV, with a typical <em>HFV </em><em>frequency</em> of (60 to 1 000) <em>HFV </em><em>inflations</em>/min]; </li>
<li>high-frequency jet <em>ventilation</em> [HFJV, with a typical <em>HFV </em><em>frequency</em> of (100 to 1 500) <em>HFV </em><em>inflations</em>/min]; and</li>
<li>high-frequency oscillatory <em>ventilation</em> [HFOV, with a typical <em>HFV </em><em>frequency</em> of (180 to 1200) <em>HFV </em><em>inflations</em>/min and typically having an active <em>expiratory phase</em>]. </li>
</ul>
<p>Additionally, <em>HFV</em> designations can be combined together or with <em>ventilation</em> at <em>rates</em> less than 150 <em>inflations</em>/min.</p>
<p>* A <em>high-frequency</em> <em>ventilator</em> is not considered a <em>physiologic closed loop-control system</em> unless it uses a physiological <em>patient</em> variable to adjust the <em>ventilation</em> therapy settings.</p>
<p>This document is also applicable to those <em>accessories</em> intended by their <em>manufacturer</em> to be connected to an <em>HFV</em> <em>breathing system</em>, or to a <em>high-frequency</em> <em>ventilator</em>, where the characteristics of those <em>accessories</em> can affect the <em>basic safety</em> or <em>essential performance</em> of the <em>high-frequency</em> <em>ventilator</em>.</p>
<p>If a clause or subclause is specifically intended to be applicable to <em>ME equipment</em> only, or to <em>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>ME equipment</em> and to <em>ME systems</em>, as relevant.</p>
<p><em>Hazards</em> inherent in the intended physiological function of <em>ME equipment</em> or <em>ME systems</em> within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of IEC 60601-1:2005.</p>
<p>NOTE 4 Additional information can be found in 4.2 of IEC 60601-1:2005+AMD1:2012.</p>
<p>This document is not applicable to <em>ME equipment</em> that is intended solely to augment the <em>ventilation</em> of spontaneously breathing <em>patients</em> within a <em>professional healthcare facility</em>.</p>
<p>This document does not specify the requirements for:</p>
<ul>
<li>non-<em>high-frequency ventilators</em> or <em>accessories</em> which provide conventional <em>ventilation</em> for use in critical care environments, which are given in ISO 80601-2-12 <sup>[23]</sup>;.</li>
</ul>
<p>NOTE 5 An <em>HFV</em> can incorporate conventional critical care <em>ventilator operational modes</em>, in which case ISO 80601-2-12 is applicable to those modes.</p>
<ul>
<li><em>ventilators</em> or <em>accessories</em> intended for anaesthetic applications, which are given in ISO 80601-2-13 <sup>[24]</sup>;</li>
<li><em>ventilators</em> or <em>accessories</em> intended for the <em>emergency medical services environment</em>, which are given in ISO 80601-2-84, the replacement for ISO 10651-3 <sup>[13]</sup>;</li>
</ul>
<p>NOTE 6 An <em>HFV</em> can incorporate <em>EMS</em> <em>ventilator</em> capability.</p>
<ul>
<li><em>ventilators</em> or <em>accessories</em> intended for <em>ventilator-dependent</em> <em>patients </em>in the <em>home healthcare environment</em><em>,</em> which are given in ISO 80601‑2-72 <sup>[26]</sup>;</li>
<li><em>ventilators</em> or <em>accessories</em> intended for home-care ventilatory support devices, which are given in ISO 80601-2-79 <sup>[27]</sup> and ISO 80601-2-80 <sup>[28]</sup>, the replacements for ISO 10651-6 <sup>[15]</sup>;</li>
<li>sleep apnoea breathing therapy <em>ME equipment</em>, which are given in ISO 80601-2-70 <sup>[25]</sup>;</li>
<li><em>bi-level </em><em>positive airway pressure</em> (<em>bi-level PAP</em>) <em>ME equipment</em>;</li>
<li><em>continuous</em><em> positive airway pressure</em> (<em>CPAP</em>) <em>ME equipment</em>;</li>
<li>respiratory high-flow <em>ME equipment</em>, which are given in ISO 80601-2-90:—<sup><a href="#_ftn1">1</a></sup>; and</li>
<li>cuirass or “iron-lung” <em>ventilation</em></li>
</ul>
<p>This document is a particular standard in the IEC 60601 series, the IEC 80601 series and the ISO 80601 series.</p>
<p> </p>
<p><a href="#_ftnref1">1</a> Under preparation. Stage at the time of publication: ISO/DIS 80601-2-90:2020.</p>
Reģistrācijas numurs (WIID)
74486
Darbības sfēra
<p>This document applies to the <em>basic safety</em> and <em>essential performance</em> of a <em>high-frequency</em> <em>ventilator</em> (<em>HFV</em>) in combination with its <em>accessories</em>, hereafter referred to as <em>ME equipment:</em></p>
<ul>
<li>intended for use in an environment that provides specialized care for <em>patients</em> whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a <em>professional healthcare facility;</em></li>
</ul>
<p>NOTE 1 For the purposes of this document, such an environment is referred to as a critical care environment. <em>High-frequency</em><em> </em><em>ventilators</em> for this environment are considered life-sustaining.</p>
<p>NOTE 2 For the purposes of this document, such a <em>high-frequency</em><em> </em><em>ventilator</em> can provide transport within a <em>professional healthcare facility</em> (i.e., be a <em>transit-operable</em> <em>ventilator</em>).</p>
<p>NOTE 3 A <em>high-frequency</em><em> ventilator</em> intended for use in transport within a <em>professional healthcare facility</em> is not considered as a <em>ventilator</em> intended for the <em>emergency medical services environment</em>.</p>
<ul>
<li>intended to be operated by a <em>healthcare professional</em> <em>operator</em>;</li>
<li>intended for those <em>patients</em> who need differing levels of support from <em>artificial ventilation</em> including <em>ventilator-dependent patients; </em>and</li>
<li>capable of providing more than 150 <em>inflations</em>/min.</li>
</ul>
<p>There are three principal designations of <em>HFV</em>:</p>
<ul>
<li>high-frequency percussive <em>ventilation</em> [HFPV, with a typical <em>HFV </em><em>frequency</em> of (60 to 1 000) <em>HFV </em><em>inflations</em>/min]; </li>
<li>high-frequency jet <em>ventilation</em> [HFJV, with a typical <em>HFV </em><em>frequency</em> of (100 to 1 500) <em>HFV </em><em>inflations</em>/min]; and</li>
<li>high-frequency oscillatory <em>ventilation</em> [HFOV, with a typical <em>HFV </em><em>frequency</em> of (180 to 1200) <em>HFV </em><em>inflations</em>/min and typically having an active <em>expiratory phase</em>]. </li>
</ul>
<p>Additionally, <em>HFV</em> designations can be combined together or with <em>ventilation</em> at <em>rates</em> less than 150 <em>inflations</em>/min.</p>
<p>* A <em>high-frequency</em> <em>ventilator</em> is not considered a <em>physiologic closed loop-control system</em> unless it uses a physiological <em>patient</em> variable to adjust the <em>ventilation</em> therapy settings.</p>
<p>This document is also applicable to those <em>accessories</em> intended by their <em>manufacturer</em> to be connected to an <em>HFV</em> <em>breathing system</em>, or to a <em>high-frequency</em> <em>ventilator</em>, where the characteristics of those <em>accessories</em> can affect the <em>basic safety</em> or <em>essential performance</em> of the <em>high-frequency</em> <em>ventilator</em>.</p>
<p>If a clause or subclause is specifically intended to be applicable to <em>ME equipment</em> only, or to <em>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>ME equipment</em> and to <em>ME systems</em>, as relevant.</p>
<p><em>Hazards</em> inherent in the intended physiological function of <em>ME equipment</em> or <em>ME systems</em> within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of IEC 60601-1:2005.</p>
<p>NOTE 4 Additional information can be found in 4.2 of IEC 60601-1:2005+AMD1:2012.</p>
<p>This document is not applicable to <em>ME equipment</em> that is intended solely to augment the <em>ventilation</em> of spontaneously breathing <em>patients</em> within a <em>professional healthcare facility</em>.</p>
<p>This document does not specify the requirements for:</p>
<ul>
<li>non-<em>high-frequency ventilators</em> or <em>accessories</em> which provide conventional <em>ventilation</em> for use in critical care environments, which are given in ISO 80601-2-12 <sup>[23]</sup>;.</li>
</ul>
<p>NOTE 5 An <em>HFV</em> can incorporate conventional critical care <em>ventilator operational modes</em>, in which case ISO 80601-2-12 is applicable to those modes.</p>
<ul>
<li><em>ventilators</em> or <em>accessories</em> intended for anaesthetic applications, which are given in ISO 80601-2-13 <sup>[24]</sup>;</li>
<li><em>ventilators</em> or <em>accessories</em> intended for the <em>emergency medical services environment</em>, which are given in ISO 80601-2-84, the replacement for ISO 10651-3 <sup>[13]</sup>;</li>
</ul>
<p>NOTE 6 An <em>HFV</em> can incorporate <em>EMS</em> <em>ventilator</em> capability.</p>
<ul>
<li><em>ventilators</em> or <em>accessories</em> intended for <em>ventilator-dependent</em> <em>patients </em>in the <em>home healthcare environment</em><em>,</em> which are given in ISO 80601‑2-72 <sup>[26]</sup>;</li>
<li><em>ventilators</em> or <em>accessories</em> intended for home-care ventilatory support devices, which are given in ISO 80601-2-79 <sup>[27]</sup> and ISO 80601-2-80 <sup>[28]</sup>, the replacements for ISO 10651-6 <sup>[15]</sup>;</li>
<li>sleep apnoea breathing therapy <em>ME equipment</em>, which are given in ISO 80601-2-70 <sup>[25]</sup>;</li>
<li><em>bi-level </em><em>positive airway pressure</em> (<em>bi-level PAP</em>) <em>ME equipment</em>;</li>
<li><em>continuous</em><em> positive airway pressure</em> (<em>CPAP</em>) <em>ME equipment</em>;</li>
<li>respiratory high-flow <em>ME equipment</em>, which are given in ISO 80601-2-90:—<sup><a href="#_ftn1">1</a></sup>; and</li>
<li>cuirass or “iron-lung” <em>ventilation</em></li>
</ul>
<p>This document is a particular standard in the IEC 60601 series, the IEC 80601 series and the ISO 80601 series.</p>
<p> </p>
<p><a href="#_ftnref1">1</a> Under preparation. Stage at the time of publication: ISO/DIS 80601-2-90:2020.</p>
