<p>This document is applicable to the <i>basic safety</i> and <i>essential performance</i> of <i>sleep apnoea breathing therapy equipment</i>, hereafter referred to as <i>ME equipment, </i>intended to alleviate the symptoms of <i>patients</i> who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the <i>patient.</i> <i>Sleep apnoea breathing therapy equipment</i> is intended for use in the <i>home healthcare environment</i> by <i>lay operators</i> as well as in professional healthcare institutions.</p>
<p>* <i>Sleep apnoea breathing therapy equipment</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 therapy settings.</p>
<p>This document excludes <i>sleep apnoea breathing therapy equipment</i> intended for use with neonates.</p>
<p>This document is applicable to <i>ME equipment</i> or an <i>ME system</i> intended for those <i>patients</i> who are not dependent on mechanical ventilation. </p>
<p>This document is not applicable to <i>ME equipment</i> or an <i>ME system</i> intended for those <i>patients</i> who are dependent on mechanical ventilation such as <i>patients</i> with central sleep apnoea. </p>
<p>This document is also applicable to those <i>accessories</i> intended by their <i>manufacturer</i> to be connected to <i>sleep apnoea breathing therapy equipment</i>, where the characteristics of those <i>accessories</i> can affect the <i>basic safety</i> or <i>essential performance</i> of the <i>sleep apnoea breathing therapy equipment</i>. </p>
<p><i>Masks</i> and application <i>accessories</i> intended for use during sleep apnoea breathing therapy<i> </i>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 <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 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 <i>accessories</i> intended for critical care ventilators for ventilator-dependent <i>patients,</i> which are given in ISO 80601‑2‑12.</p>
<p>This document does not specify the requirements for ventilators or <i>accessories</i> 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 <i>accessories</i> intended for home care ventilators for ventilator-dependent <i>patients,</i> which are given in ISO 80601-2-72<sup>[9]</sup>.</p>
<p>This document does not specify the requirements for ventilators or <i>accessories</i> 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 <i>accessories</i> 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)
75947
Scope
<p>This document is applicable to the <i>basic safety</i> and <i>essential performance</i> of <i>sleep apnoea breathing therapy equipment</i>, hereafter referred to as <i>ME equipment, </i>intended to alleviate the symptoms of <i>patients</i> who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the <i>patient.</i> <i>Sleep apnoea breathing therapy equipment</i> is intended for use in the <i>home healthcare environment</i> by <i>lay operators</i> as well as in professional healthcare institutions.</p>
<p>* <i>Sleep apnoea breathing therapy equipment</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 therapy settings.</p>
<p>This document excludes <i>sleep apnoea breathing therapy equipment</i> intended for use with neonates.</p>
<p>This document is applicable to <i>ME equipment</i> or an <i>ME system</i> intended for those <i>patients</i> who are not dependent on mechanical ventilation. </p>
<p>This document is not applicable to <i>ME equipment</i> or an <i>ME system</i> intended for those <i>patients</i> who are dependent on mechanical ventilation such as <i>patients</i> with central sleep apnoea. </p>
<p>This document is also applicable to those <i>accessories</i> intended by their <i>manufacturer</i> to be connected to <i>sleep apnoea breathing therapy equipment</i>, where the characteristics of those <i>accessories</i> can affect the <i>basic safety</i> or <i>essential performance</i> of the <i>sleep apnoea breathing therapy equipment</i>. </p>
<p><i>Masks</i> and application <i>accessories</i> intended for use during sleep apnoea breathing therapy<i> </i>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 <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 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 <i>accessories</i> intended for critical care ventilators for ventilator-dependent <i>patients,</i> which are given in ISO 80601‑2‑12.</p>
<p>This document does not specify the requirements for ventilators or <i>accessories</i> 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 <i>accessories</i> intended for home care ventilators for ventilator-dependent <i>patients,</i> which are given in ISO 80601-2-72<sup>[9]</sup>.</p>
<p>This document does not specify the requirements for ventilators or <i>accessories</i> 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 <i>accessories</i> 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>
