BS EN ISO 80369-7:2017 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.

NOTE 1 The luer connector was originally designed for use at pressures up to 300 kPa.

This part of ISO 80369 does not specify 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.

This part of ISO 80369 does not specify requirements for the following small-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).

Cross References:
ASTM D638 - 14
ISO 14971:2007 Ed 2 (R10)
ISO 80369-6:2016
ASTM D790 - 15E2
ISO 80369-20:2015
ISO 80369-1:2010 ISO 80369-2
ISO 527-2:2012
ISO 594-1:1986
ISO 5356-1:2004 Ed 3
IEC 60601-1:2005/AMD1:2012
ISO 5356-1:2015
EN 13544-2:2002+A1:2009
EN 13544-2:2002
ISO 8185:2007 Ed 3 (R10)
IEC 60601-1:2005
ISO 16142-1:2016
ISO 5356-2:2012 ED3
ISO 10241-1:2011 Ed 1
ISO 3040:1990
ISO 3040:2009 Ed 3
ISO 80369-3:2016
ISO 594-2:1998
ISO 8536-4:2010 Ed 5
ISO 14971:2007 Ed 2 (R10)
IEC 60601-1-11:2015 ED2
CR 13825:2000
ISO 178:2010 Ed 5
IEC 60601-1-12:2014 ED1
IEC 80369-5:2016
ISO 8537:2016
ISO 11040-4:2015 ED3
IEC 62366-1:2015
ISO 5356-2:2006 Ed 2
ISO 10241-2:2012
ISO 8638:2010 Ed 3


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