BS EN ISO 80369-7:2021

This document specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories. EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip connectors and Luer lock connectors. NOTE1 See Annex A. NOTE2 The Luer connector was originally designed for use at pressures up to 300kPa.This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular documents for specific medical devices or accessories.This document does not specify requirements for the following small-bore connectors, which are specified in other documents: haemodialyser, haemodiafilter and haemofilter blood compartment ports ( ISO8637 [ 5 ] and applicable portion of ISO8638 [ 6 ] referencing blood compartment ports); haemodialysis, haemodiafiltration and haemofiltration equipment connectors ( ISO8637 [ 5 ]); infusion system closure piercing connectors ( ISO8536-4 [ 4 ]). NOTE3 Manufacturers are encouraged to incorporate the small-bore connectors specified in this document into medical devices or accessories, even if currently not required by the relevant particular medical device documents. It is expected that when the relevant particular medical device documents are revised, requirements for small-bore connectors, as specified in ISO80369 , will be included. NOTE4 ISO80369-1:2018, Clause 7, specifies alternative methods of conformance with ISO80369-1:2018 , for small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not conform with this document.