Luer Testing Services to ISO 80369 Standards

North Barrington, IL – Medical Murray, a leading device development and contract manufacturing company with ISO 13485 certification and FDA registration, provides comprehensive testing services for Luers including ISO (part 1 and 2) and ISO 80369 standards.

Compliance of Luer fittings to recognized standards is critical to maintain compatibility between devices, and avoid leakage that may compromise the safety of patients and caregivers.

According to the FDA, good connector design is critical to the safe and effective use of medical devices. Because reports of patient injuries continued to grow over the years, in 2009, a new universal standard was initiated (ISO 80369) to reduce the frequency of small bore connector hazards.

“Reliable connectors are vital to the medical industry”, said Heather Koenigs, senior biomedical engineer at Medical Murray. “It is important to be aware of the changing standards in the industry and provide testing services and equipment that adhere to current regulations.”

In addition to Luer testing services, Medical Murray specializes in testing to support regulatory filings, validations, and market comparison studies, either in conjunction with the development process, or as a standalone project. All testing is performed according to pre-approved protocols that conform with applicable ISO and FDA standards.