July 2020 – The STERIS Galway, Ireland facility provides tailored service packages to assist Customers with regulatory submissions to support designers through the luer compliance process.
These services range from early-stage CAD reviews and test protocol generation to complete test execution and reporting.
The team at the Galway facility has extensive technical training and can offer ISO 17025-accredited tests to fully support ISO 80369-7 test sequences, while also retaining capability to test to ISO 594-1/-2.
What are Luer Connectors?
Luer connectors are components used in intravascular and hypodermic healthcare devices. Most syringes, needles, IV tubing sets, and catheters have luers integrated into their design.
The purpose of a luer is to provide a reversible connection of gas and liquid fluid pathways in medical systems.
Regulation
The ISO 80369 series was developed to standardize various healthcare connectors, including the intravascular luer.
The series provides design and performance test requirements to verify device efficacy and ensure patient safety through the prevention of unintentional misconnection between systems.
In relation to luer connectors, notified bodies typically require proof of compliance with ISO 80369-7, which is demonstrated though dimensional verification as well as material and part performance testing.
Find Out More
Read our TechTip, From ISO 594 to ISO 80369: Making Sense of the Latest Luer Requirements, which is an essential read for anyone involved in the design or compliance process.
The STERIS Galway team provides a range of Product Testing and Packaging Testing services to suit your requirements.
Contact Us
Contact us today to discuss your individual project requirements.
