UL now tests performance of infusion pumps

The internationally recognised 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 in-house projects.

Another choice involved investing in 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.

Anil Patel, general manager of UL Health Sciences, said: 'UL recognised the need for a third-party test lab to handle the sophisticated testing needed to meet the standard requirements.

'UL's new infusion-pump-testing expansion includes provisions for minimising environmental impacts, air flow, temperature changes and vibrations,' added Patel.

The company also will use its new testing facility to expand its scope under IECEE to include IEC 60601-2-24, so that 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.

Infusion pumps provide the 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, entitled 'Medical Electrical Equipment - Particular Requirements for the Safety of Infusion Pumps and Controllers', provides essential performance and usability requirements for infusion pumps.

The test equipment needed to conduct the IEC 60601-2-24 tests is costly and specialised, requiring specific setup 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.