| Title | <p>This document applies to the <em>basic safety</em> and <em>essential performance</em> of <em>respiratory high-flow therapy equipment,</em> as defined in 201.3.220, hereafter also referred to as <em>ME equipment </em>or<em> ME system,</em> in combination with its <em>accessories</em>:</p>
<p>— intended for use with <em>patients</em> who can breathe spontaneously; and</p>
<p>— intended for <em>patients</em> who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, which can include a <em>patient</em> whose upper airway is bypassed.</p>
<p>EXAMPLE 1 <em>Patients</em> with Type 1 Respiratory Failure who exhibit a reduction in arterial blood oxygenation.</p>
<p>EXAMPLE 2 <em>Patients</em> who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high.</p>
<p>EXAMPLE 3 <em>Patients</em> requiring humidification to improve mucociliary clearance.</p>
<p><em>Respiratory high-flow therapy equipment</em> can be intended for use in the <em>home healthcare environment</em> or intended for use in professional healthcare facilities.</p>
<p>NOTE 1 In the <em>home healthcare environment</em>, the <em>supply mains</em> is often not reliable.</p>
<p><em>Respiratory high-flow therapy equipment</em> can be:</p>
<p>— fully integrated <em>ME equipment</em>; or</p>
<p>— a combination of separate items forming a <em>ME system</em>.</p>
<p>This standard also applies to other types of respiratory equipment when that equipment includes a respiratory high-flow therapy mode.</p>
<p>NOTE 2 This standard and ISO 80601-2-12<sup>[14]</sup> are applicable to a critical care <em>ventilator</em> with a high-flow therapy mode.</p>
<p><em>Respiratory high-flow therapy equipment</em> can be <em>transit-operable</em>.</p>
<p>This document is also applicable to those <em>accessories</em> intended by their <em>manufacturer</em> to be connected to the <em>respiratory high-flow therapy equipment</em>, where the characteristics of those <em>accessories</em> can affect the <em>basic safety</em> or <em>essential performance</em> of the <em>respiratory high-flow therapy equipment</em>.</p>
<p>EXAMPLE 4 Breathing sets, connectors, <em>humidifier</em>, <em>breathing system filter</em>, external electrical power source, <em>distributed alarm system</em>, <em>high-flow nasal cannula</em>, tracheal tube, tracheostomy tube, face <em>mask</em> and supra-laryngeal airway.</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 the general standard, 7.2.13 and 8.4.1.</p>
<p>NOTE 3 Additional information can be found in the general standard, 4.2.</p>
<p>This document does not specify the requirements for:</p>
<p>— <em>ventilators</em> or <em>accessories</em> for <em>ventilator-dependent patients</em> intended for critical care applications, which are given in ISO 80601‑2‑12<sup>[14]</sup>;</p>
<p>— <em>ventilators</em> or <em>accessories</em> intended for anaesthetic applications, which are given in ISO 80601‑2‑13<sup>[15]</sup>;</p>
<p>— <em>ventilators</em> or <em>accessories</em> intended for the <em>emergency medical services environment</em>, which are given in ISO 80601‑2‑84<sup>[20]</sup>;</p>
<p>— <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 ISO 80601‑2‑72<sup>[17]</sup>;</p>
<p>— ventilatory support equipment or <em>accessories</em> intended for <em>patients</em> with ventilatory impairment, which are given in ISO 80601‑2‑79<sup>[18]</sup>;</p>
<p>— ventilatory support equipment or <em>accessories</em> intended for <em>patients</em> with ventilatory insufficiency, which are given in ISO 80601‑2‑80<sup>[19]</sup>;</p>
<p>— sleep apnoea therapy <em>ME equipment</em>, which are given in ISO 80601‑2‑70<sup>[16]</sup>;</p>
<p>— continuous positive airway pressure (CPAP) <em>ME equipment;</em></p>
<p>— high-frequency jet <em>ventilators</em> (HFJVs)<sup>[31]</sup>, which are given in ISO 80601‑2‑87<sup>[21]</sup>;</p>
<p>— gas mixers for medical use, which are given in ISO 11195<sup>[9]</sup>;</p>
<p>— flowmeters, which are given in ISO 15002<sup>[11]</sup>;</p>
<p>— high-frequency oscillatory <em>ventilators</em> (HFOVs), which are given in ISO 80601‑2‑87<sup>[21]</sup>; and</p>
<p>— cuirass or “iron-lung” ventilation equipment.</p>
<p>This document is a particular standard in the IEC 60601 series, the IEC 80601 series and the ISO 80601 series.</p> |
|---|
| Scope | <p>This document applies to the <em>basic safety</em> and <em>essential performance</em> of <em>respiratory high-flow therapy equipment,</em> as defined in 201.3.220, hereafter also referred to as <em>ME equipment </em>or<em> ME system,</em> in combination with its <em>accessories</em>:</p>
<p>— intended for use with <em>patients</em> who can breathe spontaneously; and</p>
<p>— intended for <em>patients</em> who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, which can include a <em>patient</em> whose upper airway is bypassed.</p>
<p>EXAMPLE 1 <em>Patients</em> with Type 1 Respiratory Failure who exhibit a reduction in arterial blood oxygenation.</p>
<p>EXAMPLE 2 <em>Patients</em> who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high.</p>
<p>EXAMPLE 3 <em>Patients</em> requiring humidification to improve mucociliary clearance.</p>
<p><em>Respiratory high-flow therapy equipment</em> can be intended for use in the <em>home healthcare environment</em> or intended for use in professional healthcare facilities.</p>
<p>NOTE 1 In the <em>home healthcare environment</em>, the <em>supply mains</em> is often not reliable.</p>
<p><em>Respiratory high-flow therapy equipment</em> can be:</p>
<p>— fully integrated <em>ME equipment</em>; or</p>
<p>— a combination of separate items forming a <em>ME system</em>.</p>
<p>This standard also applies to other types of respiratory equipment when that equipment includes a respiratory high-flow therapy mode.</p>
<p>NOTE 2 This standard and ISO 80601-2-12<sup>[14]</sup> are applicable to a critical care <em>ventilator</em> with a high-flow therapy mode.</p>
<p><em>Respiratory high-flow therapy equipment</em> can be <em>transit-operable</em>.</p>
<p>This document is also applicable to those <em>accessories</em> intended by their <em>manufacturer</em> to be connected to the <em>respiratory high-flow therapy equipment</em>, where the characteristics of those <em>accessories</em> can affect the <em>basic safety</em> or <em>essential performance</em> of the <em>respiratory high-flow therapy equipment</em>.</p>
<p>EXAMPLE 4 Breathing sets, connectors, <em>humidifier</em>, <em>breathing system filter</em>, external electrical power source, <em>distributed alarm system</em>, <em>high-flow nasal cannula</em>, tracheal tube, tracheostomy tube, face <em>mask</em> and supra-laryngeal airway.</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 the general standard, 7.2.13 and 8.4.1.</p>
<p>NOTE 3 Additional information can be found in the general standard, 4.2.</p>
<p>This document does not specify the requirements for:</p>
<p>— <em>ventilators</em> or <em>accessories</em> for <em>ventilator-dependent patients</em> intended for critical care applications, which are given in ISO 80601‑2‑12<sup>[14]</sup>;</p>
<p>— <em>ventilators</em> or <em>accessories</em> intended for anaesthetic applications, which are given in ISO 80601‑2‑13<sup>[15]</sup>;</p>
<p>— <em>ventilators</em> or <em>accessories</em> intended for the <em>emergency medical services environment</em>, which are given in ISO 80601‑2‑84<sup>[20]</sup>;</p>
<p>— <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 ISO 80601‑2‑72<sup>[17]</sup>;</p>
<p>— ventilatory support equipment or <em>accessories</em> intended for <em>patients</em> with ventilatory impairment, which are given in ISO 80601‑2‑79<sup>[18]</sup>;</p>
<p>— ventilatory support equipment or <em>accessories</em> intended for <em>patients</em> with ventilatory insufficiency, which are given in ISO 80601‑2‑80<sup>[19]</sup>;</p>
<p>— sleep apnoea therapy <em>ME equipment</em>, which are given in ISO 80601‑2‑70<sup>[16]</sup>;</p>
<p>— continuous positive airway pressure (CPAP) <em>ME equipment;</em></p>
<p>— high-frequency jet <em>ventilators</em> (HFJVs)<sup>[31]</sup>, which are given in ISO 80601‑2‑87<sup>[21]</sup>;</p>
<p>— gas mixers for medical use, which are given in ISO 11195<sup>[9]</sup>;</p>
<p>— flowmeters, which are given in ISO 15002<sup>[11]</sup>;</p>
<p>— high-frequency oscillatory <em>ventilators</em> (HFOVs), which are given in ISO 80601‑2‑87<sup>[21]</sup>; and</p>
<p>— cuirass or “iron-lung” ventilation equipment.</p>
<p>This document is a particular standard in the IEC 60601 series, the IEC 80601 series and the ISO 80601 series.</p> |
|---|
