A new series of ISO 80369 standards for Luer lock testing is pending release, which means that the medical device industry will be forced to redesign these small-bore tubing connectors. The existing standards, ISO 594-1 and ISO 594-2, are now lacking due to the rising risk of inadvertent incorrect connections by healthcare professionals, which, in the past, has resulted in injury to the patient and even death.
Testing methods used until recently perform both the assembly and the mechanical and leakage test method sequence separately. This meant companies needed one solution from one vendor to accommodate the mechanical tests and another solution from another vendor to perform pressure and leakage tests. With multiple systems and users in play, obtaining reliable test results was a challenge.
Recently, manufactures of connector systems, pharmaceutical
companies, and their contract partners have turned to ZwickRoell for a testing
system that minimizes errors and improves data integrity and repeatability. ZwickRoell
has developed a solution based on the single-column zwickiLine testing machine.
It features a superimposed torsion drive to handle the assembly process of the connectors. The solution also includes an integrated air pressure system with positive pressure capabilities up to 330 kPA and sub-atmospheric pressures as low as -88 kPa. The test machine controls all process parameters, including the integrated air pressure system, allowing the system to perform the complete test method, from assembly to the mechanical and leakage test, required by ISO 80369 Annex 20. This ultimately saves time and money in an area of healthcare that is critical to the safety of patients.
For more information, register for our upcoming webinar on October 8, 2020 at 11 am EDT.
Luer Lock Testing: Revisions to ISO 80396 Require Reliable Testing Solution to Ensure Data Integrity