ISO/TC 210/JWG 4

Project No.ISO 80369-2:2024
Title<p class="MsoBodyText"><span lang="EN-GB">This document specifies the design and dimensions for two <em style="mso-bidi-font-style: normal;">small-bore connectors</em> intended to be used for <em style="mso-bidi-font-style: normal;">connections</em> in respiratory <em style="mso-bidi-font-style: normal;">applications</em> of <em style="mso-bidi-font-style: normal;">medical devices</em> and <em style="mso-bidi-font-style: normal;">accessories</em>. One <em style="mso-bidi-font-style: normal;">connector</em> (R1) is intended for use on <em style="mso-bidi-font-style: normal;">medical devices</em> and <em style="mso-bidi-font-style: normal;">accessories</em> subjected to pressures up to 15 kPa (e.g. a <em style="mso-bidi-font-style: normal;">breathing system</em>). The other <em style="mso-bidi-font-style: normal;">connector</em> (R2) is intended for use on <em style="mso-bidi-font-style: normal;">medical devices</em> and <em style="mso-bidi-font-style: normal;">accessories</em> subjected to higher pressures between 15 kPa and 600 kPa (e.g. oxygen therapy tubing).</span></p> <p class="Note"><span lang="EN-GB">NOTE 1<span style="mso-tab-count: 1;">        </span>The pressure is related to pressure available at the source to which the <em style="mso-bidi-font-style: normal;">medical device</em> is connected.</span></p> <p class="Note"><span lang="EN-GB">NOTE 2<span style="mso-tab-count: 1;">        </span>The intended <em style="mso-bidi-font-style: normal;">application</em> does not preclude the use of other <em style="mso-bidi-font-style: normal;">connectors</em> on <em style="mso-bidi-font-style: normal;">medical devices</em> or <em style="mso-bidi-font-style: normal;">accessories</em> within this <em style="mso-bidi-font-style: normal;">application</em>.</span></p> <p class="Note"><span lang="EN-GB">NOTE 3<span style="mso-tab-count: 1;">        </span>Requirements for alternative connectors for this intended application are specified in ISO 80369-1.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document does not specify requirements for the <em style="mso-bidi-font-style: normal;">medical devices</em> or <em style="mso-bidi-font-style: normal;">accessories</em> that use these <em style="mso-bidi-font-style: normal;">connectors</em>. Such requirements are given in device-specific standards.</span></p> <p class="Note"><span lang="EN-GB">NOTE 4<span style="mso-tab-count: 1;">        </span>If a device-specific standard does not exist, the performance and material requirements specified in ISO 80369-1 can be used as guidance.</span></p>
Registration number (WIID)79601
Scope<p class="MsoBodyText"><span lang="EN-GB">This document specifies the design and dimensions for two <em style="mso-bidi-font-style: normal;">small-bore connectors</em> intended to be used for <em style="mso-bidi-font-style: normal;">connections</em> in respiratory <em style="mso-bidi-font-style: normal;">applications</em> of <em style="mso-bidi-font-style: normal;">medical devices</em> and <em style="mso-bidi-font-style: normal;">accessories</em>. One <em style="mso-bidi-font-style: normal;">connector</em> (R1) is intended for use on <em style="mso-bidi-font-style: normal;">medical devices</em> and <em style="mso-bidi-font-style: normal;">accessories</em> subjected to pressures up to 15 kPa (e.g. a <em style="mso-bidi-font-style: normal;">breathing system</em>). The other <em style="mso-bidi-font-style: normal;">connector</em> (R2) is intended for use on <em style="mso-bidi-font-style: normal;">medical devices</em> and <em style="mso-bidi-font-style: normal;">accessories</em> subjected to higher pressures between 15 kPa and 600 kPa (e.g. oxygen therapy tubing).</span></p> <p class="Note"><span lang="EN-GB">NOTE 1<span style="mso-tab-count: 1;">        </span>The pressure is related to pressure available at the source to which the <em style="mso-bidi-font-style: normal;">medical device</em> is connected.</span></p> <p class="Note"><span lang="EN-GB">NOTE 2<span style="mso-tab-count: 1;">        </span>The intended <em style="mso-bidi-font-style: normal;">application</em> does not preclude the use of other <em style="mso-bidi-font-style: normal;">connectors</em> on <em style="mso-bidi-font-style: normal;">medical devices</em> or <em style="mso-bidi-font-style: normal;">accessories</em> within this <em style="mso-bidi-font-style: normal;">application</em>.</span></p> <p class="Note"><span lang="EN-GB">NOTE 3<span style="mso-tab-count: 1;">        </span>Requirements for alternative connectors for this intended application are specified in ISO 80369-1.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document does not specify requirements for the <em style="mso-bidi-font-style: normal;">medical devices</em> or <em style="mso-bidi-font-style: normal;">accessories</em> that use these <em style="mso-bidi-font-style: normal;">connectors</em>. Such requirements are given in device-specific standards.</span></p> <p class="Note"><span lang="EN-GB">NOTE 4<span style="mso-tab-count: 1;">        </span>If a device-specific standard does not exist, the performance and material requirements specified in ISO 80369-1 can be used as guidance.</span></p>
StatusStandarts spēkā
ICS group11.040.10
11.040.20