SAN JOSE, Calif., Dec. 14, 2009 — Underwriters Laboratories (UL), a world leader in product safety testing and certification, announced today it opened a new IEC 60601-2-24 laboratory and expanded its testing capabilities to include specialized performance testing for infusion pumps.
"As the leading testing agency for the IEC 60601 suite of standards, UL is committed to providing the latest and most effective equipment to test and certify new infusion pumps," said Anil Patel, general manager, UL Health Sciences. "This is especially important in today’s economic environment. UL’s state-of-the-art testing facilities worldwide offer customers cost effective compliance solutions."
The internationally-recognized performance standard for infusion pumps, IEC 60601-2-24, requires specific equipment and test stations to assess performance of these devices, which play a critical role in patient health. Until now, infusion pump manufacturers had few choices to conduct the performance testing needed for global regulatory approval submissions. One of these choices included using their own research and development staff and equipment, forcing manufacturers to neglect other critical in-house projects. Another choice involved investing in the complicated test equipment, setting it up in a low-vibration environment and having a third party engineer, such as a UL representative, witness the testing.
"UL recognized the need for a third party test lab to handle the sophisticated testing needed to meet the standard requirements," said Patel. "UL’s new infusion pump testing expansion includes provisions for minimizing environmental impacts, air flow, temperature changes, and vibrations."
UL also will use its new testing facility to expand its scope under IECEE to include IEC 60601-2-24, so infusion pumps tested by UL also can receive a CB Test Certificate used as part of a manufacturer’s technical file for global regulatory submissions.
To learn more about UL’s global third party and regulatory services for the medical industry, visit www.ul.com/medical.
About infusion pumps
Infusion pumps provide measured dosing of many drug therapies for patients requiring life saving or life sustaining medications. These devices are used for critical care, emergency care, and long and short term disease maintenance.
IEC 60601-2-24 titled "Medical Electrical Equipment – Particular Requirements for the Safety of Infusion Pumps and Controllers" is the internationally recognized particular standard that provides essential performance and usability requirements for infusion pumps. The test equipment needed to conduct the IEC 60601-2-24 tests is very costly and specialized, requiring specific set up to reduce vibration and other environmental conditions that interfere with test results. Manufacturers use these test reports as part of their applications for regulatory approvals around the world.