UL Certification of medical devices

Protecting those responsible for patient care

Whether administering patient care or making sure the equipment used on patients is calibrated and ready for use, healthcare professionals have enough on-the-job stress. When you choose medical equipment evaluated by UL, you provide your valuable colleagues and employees with equipment that has been tested to nationally recognized standards for safety. Safe equipment means that healthcare professionals can continue to support the business of public health and be protected while doing so.

You know your electrical medical equipment is effective, but how do you know it is safe?

UL is a third-party testing and certification organization accredited by the Occupational Safety and Health Administration (OSHA) as a Nationally Recognized Testing Laboratory (NRTL). When you see the UL Mark on medical devices, you can be confident they have been assessed to standards for safety that not only protect patients, but protect your most important assets ... the knowledgeable healthcare professionals who use them. While the FDA may approve devices for effectiveness for intended use, the world's top medical device manufacturers choose UL as their independent third-party testing partner to provide the test reports used in their FDA submissions. And, as the most recognized certification mark among electrical inspectors and fire marshals in the U.S., a UL Mark on the medical device means fewer questions about that device's compliance with safety requirements.

What is a UL Classification Mark?

OSHA is the U.S. government agency overseeing workplace safety and requiring electrical equipment to be tested to applicable safety standards and certified by a NRTL. Medical  equipment certified by UL has been through rigorous assessment to the nationally recognized standards for electromedical safety. And once that testing is complete, UL field staff located around the world conduct thorough follow-up inspections at the factory several times a year to spot check the manufacturer's representation that the medical device is being manufacturered with the same materials and in the same configuration that UL initially assessed.

How UL certification helps address NFPA code requirements

The National Electrical Code® - also known as NFPA 70 - requires electrical equipment to be tested to applicable safety standards and certified by a NRTL. NFPA 99, the standard for healthcare facilities, establishes criteria to minimize shock, fire and explosion hazards in health care facilities. Code officials and healthcare facility staff know that a UL medical certification addresses many of the areas in these codes affecting acceptance of medical products. A UL Mark on a product represents the manufacturer's representation that its product is in compliance with the applicable required codes and standards.

UL is a proud supporter of the AAMI Foundation scholarship program