ISO 80369 Testing System
The Instron ISO 80369 system is built upon a single column universal testing machine with biaxial capabilities and is designed to support the testing of Annexes B through I*. The system includes an additional pressure transducer as well as a controller capable of generating both positive and negative pressure in line with the standard. Given the wide range of devices that can be tested, the system provides the necessary modularity to support testing syringes, IV hubs, connectors, and more.
The specific device fixture comes in two main configurations. The first is a highly flexible pneumatic grip with interchangeable faces designed to match various user-defined geometries. The entire grip assembly is mounted on a manual XY assembly to ensure consistent alignment between the device under test and the reference connector. The second configuration is specifically designed to support standard syringe sizes. In this setup, the syringe body is secured by a pneumatic lathe chuck while the rotating luer collar is secured by an adjustable pneumatic side acting grip.
* Annex K was released in 2024 and is still under evaluation for compatibility.
System Benefits
Consolidating testing to a single system and performing assembly in sequence with the testing provides an unparalleled level of efficiency, reducing the time required to evaluate devices and minimizing the number of devices required.
To maximize testing time, the fully assembled reference connector-device pair can be removed to allow the required hold period of 48 hours for stress cracking without losing the ability to use the system.
The system can be configured to allow customers to utilize existing reference connectors, considering their significant expense. To ensure proper fit and function, current connectors will need to be provided during the design of the system.
The configuration for testing IV hubs and connectors provides a simple mounting pattern on the pneumatic grips to allow companies to interface their own faces, which match their device geometry. This also enables labs to remain agile, easily prototyping new faces to support device concepts.
The system is properly rated to support performing variable tests as opposed to the standard attribute tests, as it can require destructive testing. This reduces the total number of specimens needed for a statistically significant result.
