<p class="MsoBodyText"><span lang="EN-GB">This document provides specific requirements for the basic safety and essential performance for <em style="mso-bidi-font-style: normal;">oro</em>-<em style="mso-bidi-font-style: normal;">tracheal</em> and <em style="mso-bidi-font-style: normal;">naso-tracheal tubes</em> and <em style="mso-bidi-font-style: normal;">tracheal</em> <em style="mso-bidi-font-style: normal;">tube</em> <em style="mso-bidi-font-style: normal;">connectors</em>, <em style="mso-bidi-font-style: normal;">tracheal tubes</em> with walls reinforced with metal or plastic, <em style="mso-bidi-font-style: normal;">tracheal</em> <em style="mso-bidi-font-style: normal;">tubes</em> with <em style="mso-bidi-font-style: normal;">shoulders</em>, tapered <em style="mso-bidi-font-style: normal;">tracheal</em> <em style="mso-bidi-font-style: normal;">tubes</em>, <em style="mso-bidi-font-style: normal;">tracheal</em> <em style="mso-bidi-font-style: normal;">tubes</em> with means for suctioning, monitoring or delivery of drugs or other gases, and the many other types of <em style="mso-bidi-font-style: normal;">tracheal</em> <em style="mso-bidi-font-style: normal;">tubes</em> devised for specialized applications.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">Tracheobronchial (including endobronchial) tubes (see ISO 16628), tracheostomy tubes (see ISO 5366), and supralaryngeal airways (see ISO 11712) are excluded from the scope of this document.</span></p>
<p class="MsoBodyText"><em style="mso-bidi-font-style: normal;"><span lang="EN-GB">Tracheal</span></em><span lang="EN-GB"> <em style="mso-bidi-font-style: normal;">tubes</em> intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical equipment are outside the scope of this document.</span></p>
<p class="Note"><span lang="EN-GB">NOTE 1<span style="mso-tab-count: 1;"> </span>There is guidance or rationale for this clause contained in Annex A.2.</span></p>
<p class="Note"><span lang="EN-GB">NOTE 2<span style="mso-tab-count: 1;"> </span>ISO 11990-1, ISO 11990-2, and ISO 14408 deal with laser surgery of the airway.</span></p>
Registration number (WIID)
77497
Scope
<p class="MsoBodyText"><span lang="EN-GB">This document provides specific requirements for the basic safety and essential performance for <em style="mso-bidi-font-style: normal;">oro</em>-<em style="mso-bidi-font-style: normal;">tracheal</em> and <em style="mso-bidi-font-style: normal;">naso-tracheal tubes</em> and <em style="mso-bidi-font-style: normal;">tracheal</em> <em style="mso-bidi-font-style: normal;">tube</em> <em style="mso-bidi-font-style: normal;">connectors</em>, <em style="mso-bidi-font-style: normal;">tracheal tubes</em> with walls reinforced with metal or plastic, <em style="mso-bidi-font-style: normal;">tracheal</em> <em style="mso-bidi-font-style: normal;">tubes</em> with <em style="mso-bidi-font-style: normal;">shoulders</em>, tapered <em style="mso-bidi-font-style: normal;">tracheal</em> <em style="mso-bidi-font-style: normal;">tubes</em>, <em style="mso-bidi-font-style: normal;">tracheal</em> <em style="mso-bidi-font-style: normal;">tubes</em> with means for suctioning, monitoring or delivery of drugs or other gases, and the many other types of <em style="mso-bidi-font-style: normal;">tracheal</em> <em style="mso-bidi-font-style: normal;">tubes</em> devised for specialized applications.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">Tracheobronchial (including endobronchial) tubes (see ISO 16628), tracheostomy tubes (see ISO 5366), and supralaryngeal airways (see ISO 11712) are excluded from the scope of this document.</span></p>
<p class="MsoBodyText"><em style="mso-bidi-font-style: normal;"><span lang="EN-GB">Tracheal</span></em><span lang="EN-GB"> <em style="mso-bidi-font-style: normal;">tubes</em> intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical equipment are outside the scope of this document.</span></p>
<p class="Note"><span lang="EN-GB">NOTE 1<span style="mso-tab-count: 1;"> </span>There is guidance or rationale for this clause contained in Annex A.2.</span></p>
<p class="Note"><span lang="EN-GB">NOTE 2<span style="mso-tab-count: 1;"> </span>ISO 11990-1, ISO 11990-2, and ISO 14408 deal with laser surgery of the airway.</span></p>
