<p>This document is applicable to the <em>basic safety</em> and <em>essential performance</em> of <em>sleep apnoea breathing therapy equipment</em>, hereafter referred to as <em>ME equipment, </em>intended to alleviate the symptoms of <em>patients</em> who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the <em>patient.</em> <em>Sleep apnoea breathing therapy equipment</em> is intended for use in the <em>home healthcare environment</em> by <em>lay operators</em> as well as in professional healthcare institutions.</p>
<p>* <em>Sleep apnoea breathing therapy equipment</em> is not considered to utilize a <em>physiologic closed-loop-control system</em> unless it uses a physiological <em>patient</em> variable to adjust the therapy settings.</p>
<p>This document excludes <em>sleep apnoea breathing therapy equipment</em> intended for use with neonates.</p>
<p>This document is applicable to <em>ME equipment</em> or an <em>ME system</em> intended for those <em>patients</em> who are not dependent on mechanical ventilation.</p>
<p>This document is not applicable to <em>ME equipment</em> or an <em>ME system</em> intended for those <em>patients</em> who are dependent on mechanical ventilation such as <em>patients</em> with central sleep apnoea.</p>
<p>This document is also applicable to those <em>accessories</em> intended by their <em>manufacturer</em> to be connected to <em>sleep apnoea breathing 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>sleep apnoea breathing therapy equipment</em>.</p>
<p><em>Masks</em> and application <em>accessories</em> intended for use during sleep apnoea breathing therapy<em> </em>are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document.</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 the general standard.</p>
<p>NOTE See also 4.2 of the general standard.</p>
<p>This document is not applicable to high-frequency jet ventilators (HFJVs) or high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601-2-87<sup>[13]</sup>.</p>
<p>This document does not specify the requirements for ventilators or <em>accessories</em> intended for critical care ventilators for ventilator-dependent <em>patients,</em> which are given in ISO 80601‑2‑12.</p>
<p>This document does not specify the requirements for ventilators or <em>accessories</em> intended for anaesthetic applications, which are given in ISO 80601-2-13<sup>[8]</sup>.</p>
<p>This document does not specify the requirements for ventilators or <em>accessories</em> intended for home care ventilators for ventilator-dependent <em>patients,</em> which are given in ISO 80601-2-72<sup>[9]</sup>.</p>
<p>This document does not specify the requirements for ventilators or <em>accessories</em> intended for emergency and transport, which are given in ISO 80601-2-84<sup>[12]</sup>.</p>
<p>This document does not specify the requirements for ventilators or <em>accessories</em> intended for home-care ventilatory support, which are given in ISO 80601-2-79<sup>[10]</sup> and ISO 80601‑2‑80<sup>[11]</sup>.</p>
Registration number (WIID)
87160
Scope
<p>This document is applicable to the <em>basic safety</em> and <em>essential performance</em> of <em>sleep apnoea breathing therapy equipment</em>, hereafter referred to as <em>ME equipment, </em>intended to alleviate the symptoms of <em>patients</em> who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the <em>patient.</em> <em>Sleep apnoea breathing therapy equipment</em> is intended for use in the <em>home healthcare environment</em> by <em>lay operators</em> as well as in professional healthcare institutions.</p>
<p>* <em>Sleep apnoea breathing therapy equipment</em> is not considered to utilize a <em>physiologic closed-loop-control system</em> unless it uses a physiological <em>patient</em> variable to adjust the therapy settings.</p>
<p>This document excludes <em>sleep apnoea breathing therapy equipment</em> intended for use with neonates.</p>
<p>This document is applicable to <em>ME equipment</em> or an <em>ME system</em> intended for those <em>patients</em> who are not dependent on mechanical ventilation.</p>
<p>This document is not applicable to <em>ME equipment</em> or an <em>ME system</em> intended for those <em>patients</em> who are dependent on mechanical ventilation such as <em>patients</em> with central sleep apnoea.</p>
<p>This document is also applicable to those <em>accessories</em> intended by their <em>manufacturer</em> to be connected to <em>sleep apnoea breathing 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>sleep apnoea breathing therapy equipment</em>.</p>
<p><em>Masks</em> and application <em>accessories</em> intended for use during sleep apnoea breathing therapy<em> </em>are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document.</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 the general standard.</p>
<p>NOTE See also 4.2 of the general standard.</p>
<p>This document is not applicable to high-frequency jet ventilators (HFJVs) or high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601-2-87<sup>[13]</sup>.</p>
<p>This document does not specify the requirements for ventilators or <em>accessories</em> intended for critical care ventilators for ventilator-dependent <em>patients,</em> which are given in ISO 80601‑2‑12.</p>
<p>This document does not specify the requirements for ventilators or <em>accessories</em> intended for anaesthetic applications, which are given in ISO 80601-2-13<sup>[8]</sup>.</p>
<p>This document does not specify the requirements for ventilators or <em>accessories</em> intended for home care ventilators for ventilator-dependent <em>patients,</em> which are given in ISO 80601-2-72<sup>[9]</sup>.</p>
<p>This document does not specify the requirements for ventilators or <em>accessories</em> intended for emergency and transport, which are given in ISO 80601-2-84<sup>[12]</sup>.</p>
<p>This document does not specify the requirements for ventilators or <em>accessories</em> intended for home-care ventilatory support, which are given in ISO 80601-2-79<sup>[10]</sup> and ISO 80601‑2‑80<sup>[11]</sup>.</p>
