Medical Connectors Testing | ISO 80369-1

The ISO 80369 Test Standard is the standard test method for medical connectors such as luer connectors and small bore connectors using an axial/torsion test system. 

Currently ISO 594-1, “Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment – Part 1: General Requirements” and ISO 594-2, “Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment – Part 2: General Requirements” are used for testing all Luer connectors regardless of their intended application.

In the 1990’s concern grew as an increased number of medical devices utilized Luer connectors and a rising number of misconnections in the field were reported.  In response to this risk International Organization for Standardization (ISO) introduced ISO 80369 which consists of seven parts with one part (ISO 80369-1) addressing general requirements and the remaining parts (ISO 80369-2 through -7) addressing specific applications.  The overall intent of the standard is to reduce the risk of misconnection by creating six application specific connectors which cannot interconnect with one another. 

ISO 80369-1, “Small-bore connectors for liquids and gases in healthcare applications – Part 1: General Requirements” became available at the end of 2010.  The standard introduces its intent, defines the six connectors’ applications, provides terms and definitions and outlines the procedure that ISO will use to determine the final designs to be used in ISO 80369-2 through ISO 80369-7.  The applications to be covered are as follows:

• Part 2:  Connectors for breathing systems and driving gases applications
• Part 3:  Connectors for enteral applications
• Part 4:  Connectors for urethral and urinary applications
• Part 5:  Connectors for limb cuffs inflation applications
• Part 6:  Connectors for neuraxial applications
• Part 7:  Connectors for intravascular or hypodermic applications

While the timeline for introduction of ISO 80369-2 through -7 does not appear certain ISO 80369-1 Annex B, “Mechanical tests for verifying NON-INTERCONNECTABLE characteristics” provides a test method intended to demonstrate that two connectors cannot be connected.  ISO 80369-1 is an FDA recognized standard and as such medical device manufacturers have been held to this standard.

DDL’s Product & Material Division has tested products to ISO 594 for 10 years and believes that it has the largest collection of ISO 594 reference fittings amongst third party test labs in the United States.  In an effort to address Annex B of ISO 80369-1 DDL has recently purchased an axial/torsion test system.  This test system has also been designed in anticipation of the remaining parts of the ISO 80369 set of standards and the Product & Materials Division is prepared to test to Part 1 at this time.  DDL strives to keep current with medical device test standards so to further assist its customers with their testing needs.