EN ISO 80369-7:2017 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
This part of ISO 80369 specifies dimensions and requirements for the design and functional performance of SMALL-BORECONNECTORS intended to be used forCONNECTIONS in intravascularAPPLICATIONS or hypodermicCONNECTIONS in hypodermicAPPLICATIONS ofMEDICALDEVICES and ACCESSORIES. EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female LUER SLIPCONNECTORS AND LUER LOCK CONNECTORS. NOTE 1 TheLUERCONNECTOR was originally designed for use at pressures up to 300 kPa. This part of ISO 80369 does not specify requirements for theMEDICAL DEVICES or ACCESSORIESthat use these CONNECTORS. Such requirements are given in particular International Standards for specific MEDICAL DEVICES or ACCESSORIES. This part of ISO 80369 does not specify requirements for the followingSMALL-BORE CONNECTORS@ which are specified in other International Standards: ?? haemodialyser@ haemodiafilter and haemofilter blood compartment ports (ISO 8637 and applicable portion of ISO 8638 referencing blood compartment ports); ?? haemodialysis@ haemodiafiltration and haemofiltration equipment connectors (ISO 8637); ?? infusion system closure piercing connectors (ISO 8536?4). NOTE 2 MANUFACTURERS are encouraged to incorporate the small-boreCONNECTORS specified in this part of ISO 80369 intoMIDICAL DEVICESor ACCESSORIES@ even if currently not required by the relevant particularMEDICAL DEVICEstandards. It is expected that when the relevant particularMEDICAL DEVICEstandards are revised@ requirements for SMALL-BORE CONNECTORS@ as specified in ISO 80369@ will be included. NOTE 3 ISO 80369?1:2010@ 5.8@ specifies alternative methods of compliance with ISO 80369?1:2010@ for SMALL-BORECONNECTORS intended for use with intravascularAPPLICATIONS or hypodermicAPPLICATION MEDICAL DEVICESor ACCESSORIES@ which do not comply with this part of ISO 80369.
EN ISO 80369-7:2017 history
2021EN ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
2017EN ISO 80369-7:2017 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications