<p class="MsoBodyText"><span lang="EN-GB">This document specifies requirements for <em style="mso-bidi-font-style: normal;">masks</em> and <em style="mso-bidi-font-style: normal;">accessories</em>, including any connecting element, that are required to connect the <em style="mso-bidi-font-style: normal;">patient-connection port</em> of <em style="mso-bidi-font-style: normal;">sleep apnoea breathing therapy equipment</em> to a <em style="mso-bidi-font-style: normal;">patient</em> for the application of sleep apnoea breathing therapy (e.g. nasal <em style="mso-bidi-font-style: normal;">masks</em>, <em style="mso-bidi-font-style: normal;">exhaust ports</em> and <em style="mso-bidi-font-style: normal;">headgear</em>).</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document applies to <em style="mso-bidi-font-style: normal;">masks</em> and their <em style="mso-bidi-font-style: normal;">accessories</em> used to connect <em style="mso-bidi-font-style: normal;">sleep apnoea breathing therapy equipment</em> to the <em style="mso-bidi-font-style: normal;">patient</em>.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">The requirements in this document take priority over the requirements in ISO 18190.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document does not cover <em style="mso-bidi-font-style: normal;">oral appliances</em>.</span></p>
<p class="Note"><span lang="EN-GB">NOTE<span style="mso-tab-count: 1;"> </span></span><span lang="EN-GB">This document has been prepared to address the relevant </span><span lang="EN-GB">essential principles[14] and labelling principles[15] of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex I.</span></p>
Registration number (WIID)
89025
Scope
<p class="MsoBodyText"><span lang="EN-GB">This document specifies requirements for <em style="mso-bidi-font-style: normal;">masks</em> and <em style="mso-bidi-font-style: normal;">accessories</em>, including any connecting element, that are required to connect the <em style="mso-bidi-font-style: normal;">patient-connection port</em> of <em style="mso-bidi-font-style: normal;">sleep apnoea breathing therapy equipment</em> to a <em style="mso-bidi-font-style: normal;">patient</em> for the application of sleep apnoea breathing therapy (e.g. nasal <em style="mso-bidi-font-style: normal;">masks</em>, <em style="mso-bidi-font-style: normal;">exhaust ports</em> and <em style="mso-bidi-font-style: normal;">headgear</em>).</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document applies to <em style="mso-bidi-font-style: normal;">masks</em> and their <em style="mso-bidi-font-style: normal;">accessories</em> used to connect <em style="mso-bidi-font-style: normal;">sleep apnoea breathing therapy equipment</em> to the <em style="mso-bidi-font-style: normal;">patient</em>.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">The requirements in this document take priority over the requirements in ISO 18190.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document does not cover <em style="mso-bidi-font-style: normal;">oral appliances</em>.</span></p>
<p class="Note"><span lang="EN-GB">NOTE<span style="mso-tab-count: 1;"> </span></span><span lang="EN-GB">This document has been prepared to address the relevant </span><span lang="EN-GB">essential principles[14] and labelling principles[15] of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex I.</span></p>
