ISO DIS 80369-7

Abstract

This part of ISO 80369 specifies requirements for SMALL-BORE CONNECTORS intended to be used as intravascular CONNECTIONS in intravascular APPLICATIONS or hypodermic CONNECTIONS in hypodermic APPLICATIONS of MEDICAL DEVICES and related ACCESSORIES. <br>This part of ISO 80369 specifies dimensions and requirements for the design and functional performance of these SMALL-BORE CONNECTORS intended to be used with MEDICAL DEVICES. This part of ISO 80369 does not specify the dimensions and requirements for the MEDICAL DEVICES or ACCESSORIES that use these CONNECTORS. Such requirements are given in particular International Standards for specific MEDICAL DEVICES or ACCESSORIES. <br>EXAMPLES Hypodermic syringes and needles or IV cannulae with male and female LUER SLIP CONNECTORS and LUER LOCK CONNECTORS. <br>NOTE 1 Hypodermic use includes percutaneous infusion and injection as well as pressurizing and depressurizing inflation cuffs used to hold invasive MEDICAL DEVICES in place. <br>NOTE 2 The LUER CONNECTOR was designed for use at pressures up to 300 kPa. This part of ISO 80369 does not specify requirements for the following CONNECTORS which are specified in other standards: <br>-&#160;haemodialyser, haemodiafilter and haemofilter blood compartment ports [ISO 8637 and applicable portion of ISO 8638 referencing blood compartment ports] <br>-&#160;haemodialysis, haemodiafiltration and haemofiltration equipment CONNECTORS [ISO 8637] <br>-&#160;infusion system closure piercing CONNECTORS [ISO 8536-4] <br>NOTE 3 MANUFACTURERS are encouraged to incorporate the SMALL-BORE CONNECTORS specified in this part of ISO 80369 into MEDICAL DEVICES, medical systems or ACCESSORIES, even if currently not required by the relevant particular MEDICAL DEVICE standards. It is expected that when the relevant particular MEDICAL DEVICE standards are revised, requirements for SMALL-BORE CONNECTORS, as specified in ISO 80369, will be included.