<p>This document specifies essential performance and safety requirements for <em>cuff</em> <em>pressure</em> <em>indicators</em> used to indicate the <em>intracuff pressure</em> of <em>airway devices</em>, such as <em>supralaryngeal airways</em>, <em>tracheal tubes</em> or <em>tracheostomy tubes</em>.</p>
<p>This document is also applicable to devices that combine <em>intracuff</em> <em>pressure</em> indication with a method of <em>cuff</em> inflation (such as a syringe or pump). The device can also provide a method of automatically maintaining <em>cuff</em> inflation at a specific pressure or within a pressure range.</p>
<p>The requirements specified in this document apply to stand-alone <em>cuff pressure indicators</em> and those integrated into other medical devices e.g. ventilators anaesthesia workstations etc.</p>
Registration number (WIID)
75351
Scope
<p>This document specifies essential performance and safety requirements for <em>cuff</em> <em>pressure</em> <em>indicators</em> used to indicate the <em>intracuff pressure</em> of <em>airway devices</em>, such as <em>supralaryngeal airways</em>, <em>tracheal tubes</em> or <em>tracheostomy tubes</em>.</p>
<p>This document is also applicable to devices that combine <em>intracuff</em> <em>pressure</em> indication with a method of <em>cuff</em> inflation (such as a syringe or pump). The device can also provide a method of automatically maintaining <em>cuff</em> inflation at a specific pressure or within a pressure range.</p>
<p>The requirements specified in this document apply to stand-alone <em>cuff pressure indicators</em> and those integrated into other medical devices e.g. ventilators anaesthesia workstations etc.</p>
