| Title | <p><span lang="EN-GB">This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in </span><span lang="AR-SA"></span><span lang="EN-GB">201.3.262</span><span lang="EN-GB">, hereafter also referred to as ME equipment or ME system, in combination with its accessories:</span></p>
<ul>
<li><span lang="EN-GB">intended for use with patients who can breathe spontaneously; and</span></li>
<li><span lang="EN-GB">intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, which can include a patient whose upper airway is bypassed. </span></li>
</ul>
<p><span lang="EN-GB">EXAMPLE 1 Patients with </span><span lang="EN-GB">Type 1 Respiratory Failure who exhibit a reduction in arterial blood oxygenation. </span></p>
<p><span lang="EN-GB">EXAMPLE 2 Patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high</span><span lang="EN-GB">.</span></p>
<p><span lang="EN-GB">EXAMPLE 3 Patients requiring humidification to improve mucociliary clearance. </span></p>
<p><span lang="EN-GB">Respiratory high-flow therapy equipment</span><span lang="EN-GB"> is utilized in both professional healthcare facilities and the home healthcare environment. </span><span lang="EN-GB">This standard specifically addresses </span><span lang="EN-GB">respiratory high-flow therapy equipment</span><span lang="EN-GB"> for acute or infant care, predominantly found in hospitals</span><span lang="EN-GB">. A separate document for long term high-flow therapy in the home healthcare environment is expected to be forthcoming.</span></p>
<p><span lang="EN-GB">Respiratory high-flow therapy equipment</span><span lang="EN-GB"> can be: </span></p>
<ul>
<li><span lang="EN-GB">fully integrated ME equipment; or</span></li>
<li><span lang="EN-GB">a combination of separate items forming a ME system. </span></li>
</ul>
<p><span lang="EN-GB">This document also applies to </span><span lang="EN-GB">other types of respiratory equipment when that equipment includes a respiratory high-flow therapy mode. </span></p>
<p><span lang="EN-GB">NOTE 2 This document and ISO 80601-2-12 are applicable to a critical care ventilator with a high-flow therapy mode.</span></p>
<p><span lang="EN-GB">NOTE 3 This document and ISO 80601-2-72 are applicable to ventilator for ventilator-dependent patients in the home healthcare environment with a high-flow therapy mode.</span></p>
<p><span lang="EN-GB">NOTE 4 This document and ISO 80601-2-13 are applicable to an anaesthetic workstation with a high-flow therapy mode.</span></p>
<p><span lang="EN-GB">Respiratory high-flow therapy equipment</span><span lang="EN-GB"> can be transit-operable.</span></p>
<p><span lang="EN-GB">This document is also applicable to those accessories intended by their manufacturer to be connected to the respiratory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the respiratory high-flow therapy equipment.</span></p>
<p><span lang="EN-GB">EXAMPLE 4 Breathing sets, connectors, humidifier, breathing system filter, external electrical power source, distributed alarm system, </span>high-flow nasal cannula, tracheal tube, tracheostomy tube, face mask and supra-laryngeal airway<span lang="EN-GB">.</span></p>
<p><span lang="EN-GB">NOTE 5 Accessories are assessed with the relevant clauses of this document when configured as part of respiratory high-flow therapy equipment.</span></p>
<p><span lang="EN-GB">If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems 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 ME equipment and to ME systems, as relevant.</span></p>
<p><span lang="EN-GB">Hazards</span><span lang="EN-GB"> inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in </span><span lang="EN-GB">the general standard</span><span lang="EN-GB">, 7.2.13 and 8.4.1.</span></p>
<p><span lang="EN-GB">NOTE 6 Additional information can be found in </span><span lang="EN-GB">the general standard</span><span lang="EN-GB">, 4.2.</span></p>
<p><span lang="EN-GB">This document does not specify the requirements for:</span></p>
<ul>
<li><span lang="EN-GB">ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12;</span></li>
<li><span lang="EN-GB">ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13;</span></li>
<li><span lang="EN-GB">ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84;</span></li>
<li><span lang="EN-GB">ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72;</span></li>
<li><span lang="EN-GB">ventilatory support equipment or accessories intended for </span><span lang="EN-GB">patients</span><span lang="EN-GB"> with</span><span lang="EN-GB"> ventilatory impairment, which are given in ISO 80601‑2‑79;</span></li>
<li><span lang="EN-GB">ventilatory support equipment or accessories intended for </span><span lang="EN-GB">patients</span><span lang="EN-GB"> with</span><span lang="EN-GB"> ventilatory insufficiency, which are given in ISO 80601‑2‑80;</span></li>
<li><span lang="EN-GB">sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70;</span></li>
<li><span lang="EN-GB">continuous positive airway pressure (CPAP) ME equipment;</span></li>
<li><span lang="EN-GB">high-frequency jet ventilators (HFJVs)</span><span lang="AR-SA"></span><span lang="EN-GB">[31]</span><span lang="EN-GB">, which are given in ISO 80601‑2‑87;</span></li>
<li><span lang="EN-GB">gas mixers for medical use, which are given in ISO 11195;</span></li>
<li><span lang="EN-GB">flowmeters, which are given in ISO 15002;</span></li>
<li><span lang="EN-GB">high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601‑2‑87; and</span></li>
<li><span lang="EN-GB">cuirass or “iron-lung” ventilation equipment.</span></li>
</ul>
<p><span lang="EN-GB">This document is a particular standard in the </span><span lang="EN-GB">IEC</span><span lang="EN-GB"> 60601 </span><span lang="EN-GB">series, the </span><span lang="EN-GB">IEC</span><span lang="EN-GB"> 80601 series </span><span lang="EN-GB">and the ISO 80601 series</span><span lang="EN-GB">.</span></p> |
|---|
| Scope | <p><span lang="EN-GB">This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in </span><span lang="AR-SA"></span><span lang="EN-GB">201.3.262</span><span lang="EN-GB">, hereafter also referred to as ME equipment or ME system, in combination with its accessories:</span></p>
<ul>
<li><span lang="EN-GB">intended for use with patients who can breathe spontaneously; and</span></li>
<li><span lang="EN-GB">intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, which can include a patient whose upper airway is bypassed. </span></li>
</ul>
<p><span lang="EN-GB">EXAMPLE 1 Patients with </span><span lang="EN-GB">Type 1 Respiratory Failure who exhibit a reduction in arterial blood oxygenation. </span></p>
<p><span lang="EN-GB">EXAMPLE 2 Patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high</span><span lang="EN-GB">.</span></p>
<p><span lang="EN-GB">EXAMPLE 3 Patients requiring humidification to improve mucociliary clearance. </span></p>
<p><span lang="EN-GB">Respiratory high-flow therapy equipment</span><span lang="EN-GB"> is utilized in both professional healthcare facilities and the home healthcare environment. </span><span lang="EN-GB">This standard specifically addresses </span><span lang="EN-GB">respiratory high-flow therapy equipment</span><span lang="EN-GB"> for acute or infant care, predominantly found in hospitals</span><span lang="EN-GB">. A separate document for long term high-flow therapy in the home healthcare environment is expected to be forthcoming.</span></p>
<p><span lang="EN-GB">Respiratory high-flow therapy equipment</span><span lang="EN-GB"> can be: </span></p>
<ul>
<li><span lang="EN-GB">fully integrated ME equipment; or</span></li>
<li><span lang="EN-GB">a combination of separate items forming a ME system. </span></li>
</ul>
<p><span lang="EN-GB">This document also applies to </span><span lang="EN-GB">other types of respiratory equipment when that equipment includes a respiratory high-flow therapy mode. </span></p>
<p><span lang="EN-GB">NOTE 2 This document and ISO 80601-2-12 are applicable to a critical care ventilator with a high-flow therapy mode.</span></p>
<p><span lang="EN-GB">NOTE 3 This document and ISO 80601-2-72 are applicable to ventilator for ventilator-dependent patients in the home healthcare environment with a high-flow therapy mode.</span></p>
<p><span lang="EN-GB">NOTE 4 This document and ISO 80601-2-13 are applicable to an anaesthetic workstation with a high-flow therapy mode.</span></p>
<p><span lang="EN-GB">Respiratory high-flow therapy equipment</span><span lang="EN-GB"> can be transit-operable.</span></p>
<p><span lang="EN-GB">This document is also applicable to those accessories intended by their manufacturer to be connected to the respiratory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the respiratory high-flow therapy equipment.</span></p>
<p><span lang="EN-GB">EXAMPLE 4 Breathing sets, connectors, humidifier, breathing system filter, external electrical power source, distributed alarm system, </span>high-flow nasal cannula, tracheal tube, tracheostomy tube, face mask and supra-laryngeal airway<span lang="EN-GB">.</span></p>
<p><span lang="EN-GB">NOTE 5 Accessories are assessed with the relevant clauses of this document when configured as part of respiratory high-flow therapy equipment.</span></p>
<p><span lang="EN-GB">If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems 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 ME equipment and to ME systems, as relevant.</span></p>
<p><span lang="EN-GB">Hazards</span><span lang="EN-GB"> inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in </span><span lang="EN-GB">the general standard</span><span lang="EN-GB">, 7.2.13 and 8.4.1.</span></p>
<p><span lang="EN-GB">NOTE 6 Additional information can be found in </span><span lang="EN-GB">the general standard</span><span lang="EN-GB">, 4.2.</span></p>
<p><span lang="EN-GB">This document does not specify the requirements for:</span></p>
<ul>
<li><span lang="EN-GB">ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12;</span></li>
<li><span lang="EN-GB">ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13;</span></li>
<li><span lang="EN-GB">ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84;</span></li>
<li><span lang="EN-GB">ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72;</span></li>
<li><span lang="EN-GB">ventilatory support equipment or accessories intended for </span><span lang="EN-GB">patients</span><span lang="EN-GB"> with</span><span lang="EN-GB"> ventilatory impairment, which are given in ISO 80601‑2‑79;</span></li>
<li><span lang="EN-GB">ventilatory support equipment or accessories intended for </span><span lang="EN-GB">patients</span><span lang="EN-GB"> with</span><span lang="EN-GB"> ventilatory insufficiency, which are given in ISO 80601‑2‑80;</span></li>
<li><span lang="EN-GB">sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70;</span></li>
<li><span lang="EN-GB">continuous positive airway pressure (CPAP) ME equipment;</span></li>
<li><span lang="EN-GB">high-frequency jet ventilators (HFJVs)</span><span lang="AR-SA"></span><span lang="EN-GB">[31]</span><span lang="EN-GB">, which are given in ISO 80601‑2‑87;</span></li>
<li><span lang="EN-GB">gas mixers for medical use, which are given in ISO 11195;</span></li>
<li><span lang="EN-GB">flowmeters, which are given in ISO 15002;</span></li>
<li><span lang="EN-GB">high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601‑2‑87; and</span></li>
<li><span lang="EN-GB">cuirass or “iron-lung” ventilation equipment.</span></li>
</ul>
<p><span lang="EN-GB">This document is a particular standard in the </span><span lang="EN-GB">IEC</span><span lang="EN-GB"> 60601 </span><span lang="EN-GB">series, the </span><span lang="EN-GB">IEC</span><span lang="EN-GB"> 80601 series </span><span lang="EN-GB">and the ISO 80601 series</span><span lang="EN-GB">.</span></p> |
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