DDL has expanded the scope of its ISO/IEC 17025:2005 accreditation from the American Association for Laboratory Accreditation (A2LA) to include ISO 594-1 and ISO 594-2 testing for conical (Luer) fittings.
A conical Luer fitting is the most common means of achieving a leak-free connection between two medical devices (e.g. a syringe and hypodermic needle) that carry small volumes of fluids. There are two varieties of Luer taper connections known as Luer-lock and Luer-slip. ISO 594-1 defines the dimensions and validation test specifications of Luer-slip fittings. ISO 594-2 defines the dimensions and validation test specifications of Luer-lock fittings. DDL tests both standalone Luer adapters and Luers which are components of various devices, and has large collection of reference connectors which allows for dramatically reduced timelines to complete testing.
ISO/IEC 17025:2005 is the international standard by which a laboratory’s commitment to quality and technical competence are evaluated. DDL previously achieved ISO/IEC 17025:2005 accreditation for its distribution testing, and strength and integrity testing by demonstrating its laboratories are in compliance with the standard and A2LA accreditation requirements.
“This expansion of our ISO 17025 accreditation to include ISO 594-1 and ISO 594-2 testing further demonstrates our commitment to continuously improve our Quality system and offer superior service within our industry,” says Corey Hensel, General Manager, DDL, Inc. “This accreditation also further demonstrates our technical competency and capability to produce precise and accurate test data our customers can rely upon to meet their regulatory requirements.”
Please visit www.testedandproven.com/about-ddl/certifications/ to download a copy of DDL’s ISO/IEC 17025:2005 accreditation.