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Infusion Pump Testing and Regulatory Requirements

The U.S. FDA recognizes AAMI TIR101:2021 to demonstrate fluid delivery performance. This standard provides clinically relevant data on how a pump performs and meets regulatory requirements for FDA submission.

Infusion pump feeding IV drip into patients.

Infusion pumps are used for critical and emergency care situations, so they require testing to meet safety and performance requirements. UL Solutions can help you test and certify your infusion pumps to both IEC 60601-2-24 and IEC 60601-1-11.

The U.S. Food and Drug Administration (FDA) has recognized AAMI TIR101:2021 as a consensus standard in May of 2022. This standard sets out important performance criteria for infusion pumps. UL Solutions has laboratories and technical expertise to help you test your infusion pumps and provide output reports detailing your products’ compliance with AAMI TIR101:2021.

Our Minneapolis laboratory has all of the testing capabilities to simulate the environmental and testing considerations required by AAMI TIR-101. UL Solutions is building testing capabilities in laboratories across Europe and Asia.

This work can support submission and ongoing work with the FDA as well as independent third-party certification for existing products.

Why partner with UL Solutions?

Dedicated to healthcare industry innovation, we leverage decades of technical, regulatory, and clinical expertise to help you manage regulatory challenges and bring safer products to the market.

Our testing and compliance engineers work closely with standards committees to stay up to date on all the new amendments and upcoming changes. These committees include the American National Standards Institute (ANSI), the Association for the Advancement of Medical Instrumentation (AAMI) and the International Electrotechnical Commission (IEC). UL Solutions has several U.S. FDA ASCA-accredited testing laboratories across Asia, Europe and the U.S.

We provide a single source for your needs, helping you save time and money. Our comprehensive suite of services includes end-product testing, certification, validation (electromagnetic compatibility (EMC), wireless, safety, interoperability, cybersecurity, biocompatibility) and our Global Market Access service.


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