What you should know about the new ISO 80369-7 Standard

ISO 80369-7 is the newly published standard that replaces the ISO 594 series of standards. The ‘Part 7’ standard is specifically 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. ISO 80369-7 includes the dimensions and drawings of connectors intended to be used as conical fittings with a 6 % Luer taper for connections. ISO 80369-7 contains the following major technical revisions to the previous ISO 594-1 and ISO 594-2 standards:

  • The addition of new terms and definitions to ISO 80369-7 has more clearly defined the various types of Luer connectors included in the scope of this standard. Unlike the previous ISO 594-1 and ISO 594-2 standards, which only described the requirements for the fittings of these connectors, ISO 80369-7 more broadly describes the requirements for the connectors used for intravascular or hypodermic applications. An important terminology distinction is important to define here because the previous standards do not contain the terms ‘connectors’ or ‘connection’ and the ISO 80369 family of standards does not use the term ‘fitting’.
  • In order to reduce the risk of misconnections between medical devices or accessories for different applications with the small-bore connectors that are being developed under other parts of the ISO 80369 series of standards, requirements for certain dimensions not previously identified in ISO 594-1 and ISO 594-2 are added to this standard. These new dimensions represent the current design and dimensions of Luer connectors in clinical use at the time this standard was developed. The more commonly used equivalent angular dimension (in degrees) is used in ISO 80369-7 instead of the term ‘6% Luer taper’ which is used throughout the ISO 594 series of standards.
  • Requirements for gauging of Luer connectors made from semi-rigid materials using plug and ring test gauges have been replaced by dimensional requirements, which are more precise and essential for reducing the risk of misconnection with the other connectors identified in ISO 80369-1.
  • There is now one common set of dimensions and requirement for Luer connectors made from semi-rigid materials and rigid materials. This consolidation of requirements has further reduced the risk of misconnection with other small-bore connectors. 
  • ISO 80369-7 does not define any gages. Use the gages defined in ISO 594-1 to test ISO 80369-7 connectors.
  • ISO 80369-7 specifies the Reference Fittings to be use to functionally test the connectors.
  • Gages are used to test the connectors in a manufacturing setting for go-nogo evaluation; reference fittings are used for the testing described in ISO 80369-20 to functionally test the connectors
  • ISO 80369-7 does not specify requirements for the following connectors which are specified in other standards:
    • haemodialyser, haemodiafilter and haemofilter blood compartment ports [ISO 8637 and applicable portion 217 of ISO 8638 referencing blood compartment ports]
    • haemodialysis, haemodiafiltration and haemofiltration equipment connectors [ISO 8637]
    • infusion system closure piercing connectors [ISO 8536-4]

Adapted from: http://www.ring-plug-thread-gages.com/ti-spec-ISO-80369-7.htm