Services for Infusion Pump Manufacturers
With specialized testing capability and global accreditations specific for infusion pumps, UL offers both entry-level and experienced infusion pump manufacturers the service required to gain access to global markets.
Infusion pumps provide measured dosing of many drug therapies for patifents 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 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 to apply for market approval around the world.
Locations offer local accreditation for Global Market Access
UL's full service laboratories in San Jose, Calif., and Taiwan both have the test equipment and trained technical staff to provide a full suite of services to help infusion pump manufacturers apply to global regulatory markets. As a CB Testing Laboratory (CBTL) under the CB Scheme, UL can also provide test data that can be used in your technical files for global regulatory submissions.
Why customers come to UL
With one of the only CB Test Laboratories for infusion pumps, UL provides manufacturers with options when it comes to performance testing of their equipment. Manufacturers can save time in traveling to remote test locations freeing up their valuable R&D staff and equipment to focus on other work.
Working with UL allows infusion pump manufacturers to control the testing schedule, rather than getting bumped by other internal priorities. And since UL is an end-to-end certification and third party regulatory services provider for the medical industry, infusion pump manufacturers can leverage UL's global end-to-end certifications, pre-clinical test reports, packaging validation, shelf-life testing and third-party regulatory services to apply for global market approvals.
UL services for both small and large manufacturers
- Proactive review evaluation
- R&D testing
- Verification testing
- Custom programs and protocols
- Full UL and C-UL certification
- CB Scheme Report and Certificate
- Pre-clinical test reports
- CRO services
- Informative test report you can use to apply for regulatory approvals in other markets
Additional Resources
- Learn more about FDA's Infusion Pump Improvement Initiative
