DDL is now offering testing based on the recently published ISO 80369-7 standard that specifies requirements and test methods for Luer connectors, in addition to the published parts of ISO 80369 for enteral (EnFit) and neuraxial connectors.
For over a decade, work has been underway to develop the ISO 80369 series of small-bore connector standards as an eventual replacement to the ISO 594-1 and ISO 594-2 standards. ISO 80369-7 has been formally published and ISO 594-1 and 594-2 have been withdrawn.
“The ISO 80369 series of standards for small-bore connectors seeks to better address patient injuries and deaths, particularly for Luers, which are used ubiquitously and on many types of incompatible devices and have contributed to many incidences of dangerous medical connections over the years,” said Levi Loesch, Product and Materials Engineer, DDL, Inc. “The timeline for transitioning from ISO 594 to 80369-7 is still to be determined by the FDA. In the meantime, DDL will offer testing to ISO 80369-7 and the other published parts of ISO 80369, while also continuing to offer ISO 594 testing.”
The sections of ISO 80369 include:
• Part 1: General Requirements
• 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 cuff inflation applications
• Part 6: Connectors for neuraxial applications
• Part 7: Connectors for intravascular or hypodermic applications
• Part 20: Test methods for each application
Please contact us for more information on ISO 80369 testing and other DDL test offerings.