BS EN ISO 80369-7:2021

What is ISO 80369-7 about?  

ISO 80369-7 is one of a series of documents for small-bore connectors for liquids and gases in healthcare applications that 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.

ISO 80369-7 does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given documents for specific medical devices or accessories. 

ISO 80369-7 does not specify requirements for the following small-bore connectors, which are specified in other documents, 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), and infusion system closure piercing connectors (ISO 8536-4). 

Note: The Luer connector was originally designed for use at pressures up to 300 kPa. 

Note 2: 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 medical device documents. It is expected that when the relevant medical device documents are revised, requirements for smallbore connectors, as specified in ISO 80369, will be included. 

Note 3: ISO 80369-1:2018, Clause 7, specifies alternative methods of conformance with ISO 80369-1:2018, for small-bore connectors intended for use with intravascular applications or hypodermic applications medical devices or accessories, which do not conform with this document. 

Who is ISO 80369-7 for? 

ISO 80369-7 on small-bore connectors for liquids and gases in healthcare applications is applicable to- 

• Manufacturers of small-bore connectors for liquids and gases in healthcare 
• Medical laboratories 
• Research facilities 

Why should you use ISO 80369-7? 

Luer connector are small-bore connector that contains a conical mating surface with a 6 % (Luer) taper intended for use in intravascular or hypodermic applications of medical devices and related accessories. The ISO 80369 series was developed to prevent misconnection between small-bore connectors used in different applications. 

ISO 80369-7 guideline provides necessary requirements to verify the designs and dimensions of small-bore connectors to ensure that they do not misconnect with other small-bore connectors, and they safely and securely connect with their mating half. 

What’s changed since the last update? 

BS EN ISO 80369-7:2021 supersedes ISO 80369-7:2016, which has been withdrawn. BS EN ISO 80369-7:2021 has some technical changes with respect to ISO 80369-7:2016, these include: 

• Tolerances of several reference connector dimensions are increased to facilitate easier manufacturing and certification. Most of the affected tolerances are for features that do not contact the test connector and therefore do not affect the test results. The angle tolerance for the bearing side of the threads do contact the connector under test but the change in the tolerance is considered likely have minimal to no effect on test outcomes 
• Tolerances of several reference connector dimensions are increased to facilitate easier manufacturing and certification. Most of the affected tolerances are for features that do not contact the test connector and therefore do not affect the test results. The angle tolerance for the bearing side of the threads do contact the connector under test but the change in the tolerance is considered likely have minimal to no effect on test outcomes 
• The distance from the tip of the connector to the bottom of the first complete thread profile of the internal thread (t dimension) has been made an auxiliary dimension due to the difficulty in its measurement. The functional impact of the dimension is evaluated with the resistance to separation (from axial load) functional test
• The N1 and N2 dimensions of the female Luer lock connector variant A (with lugs at a right angle to the axis) have been changed to allow measurement from the open end of the connector, to better ensure compatibility at the extreme of the design space