<p>This document specifies dimensions and requirements for the design and functional performance of <em>small-bore connectors</em> intended to be used for <em>connections</em> in intravascular <em>applications</em> or hypodermic <em>connections</em> in hypodermic <em>applications</em> of <em>medical devices</em> and <em>accessories</em>.</p>
<p>EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female <em>Luer slip connectors</em> and <em>Luer lock connectors</em>.</p>
<p>NOTE 1 See Annex A.</p>
<p>NOTE 2 The <em>Luer connector</em> was originally designed for use at pressures up to 300 kPa.</p>
<p>This document does not specify requirements for the<em>medical devices</em> or <em>accessories</em> that use these <em>connectors</em>. Such requirements are given in particular documents for specific <em>medical devices</em> or <em>accessories</em>.</p>
<p>This document does not specify requirements for the following <em>small-bore connectors,</em> which are specified in other documents:</p>
<p>- haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637<sup> [5] </sup>and applicable portion of ISO 8638 <sup>[</sup> <sup>6</sup><sup>]</sup> referencing blood compartment ports);</p>
<p>- haemodialysis, haemodiafiltration and haemofiltration equipment <em>connectors</em> (ISO 8637 <sup>[5]</sup>);</p>
<p>- infusion system closure piercing <em>connectors</em> (ISO 8536-4 <sup>[</sup><sup>4</sup><sup>]</sup>).</p>
<p>NOTE 3 <em>Manufacturers</em> are encouraged to incorporate the<em>small-bore connectors</em> specified in this document into <em>medical devices</em> or <em>accessories</em>, even if currently not required by the relevant particular <em>medical device</em> documents. It is expected that when the relevant particular <em>medical device</em> documents are revised, requirements for <em>small-bore connectors</em>, as specified in ISO 80369, will be included.</p>
<p>NOTE 4 ISO 80369-1:2018, Clause 7, specifies alternative methods of conformance with ISO 80369-1:2018, for <em>small-bore connectors</em> intended for use with intravascular <em>applications</em> or hypodermic <em>application medical devices</em> or <em>accessories</em>, which do not conform with this document.</p>
Registration number (WIID)
79173
Scope
<p>This document specifies dimensions and requirements for the design and functional performance of <em>small-bore connectors</em> intended to be used for <em>connections</em> in intravascular <em>applications</em> or hypodermic <em>connections</em> in hypodermic <em>applications</em> of <em>medical devices</em> and <em>accessories</em>.</p>
<p>EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female <em>Luer slip connectors</em> and <em>Luer lock connectors</em>.</p>
<p>NOTE 1 See Annex A.</p>
<p>NOTE 2 The <em>Luer connector</em> was originally designed for use at pressures up to 300 kPa.</p>
<p>This document does not specify requirements for the<em>medical devices</em> or <em>accessories</em> that use these <em>connectors</em>. Such requirements are given in particular documents for specific <em>medical devices</em> or <em>accessories</em>.</p>
<p>This document does not specify requirements for the following <em>small-bore connectors,</em> which are specified in other documents:</p>
<p>- haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637<sup> [5] </sup>and applicable portion of ISO 8638 <sup>[</sup> <sup>6</sup><sup>]</sup> referencing blood compartment ports);</p>
<p>- haemodialysis, haemodiafiltration and haemofiltration equipment <em>connectors</em> (ISO 8637 <sup>[5]</sup>);</p>
<p>- infusion system closure piercing <em>connectors</em> (ISO 8536-4 <sup>[</sup><sup>4</sup><sup>]</sup>).</p>
<p>NOTE 3 <em>Manufacturers</em> are encouraged to incorporate the<em>small-bore connectors</em> specified in this document into <em>medical devices</em> or <em>accessories</em>, even if currently not required by the relevant particular <em>medical device</em> documents. It is expected that when the relevant particular <em>medical device</em> documents are revised, requirements for <em>small-bore connectors</em>, as specified in ISO 80369, will be included.</p>
<p>NOTE 4 ISO 80369-1:2018, Clause 7, specifies alternative methods of conformance with ISO 80369-1:2018, for <em>small-bore connectors</em> intended for use with intravascular <em>applications</em> or hypodermic <em>application medical devices</em> or <em>accessories</em>, which do not conform with this document.</p>
