When used as a medical device, thermal imaging can be a valuable screening tool to measure human body temperature related to possible infection or illness. This technology is convenient and efficient and can be performed in a touchless/non-invasive manner providing results in a matter of seconds to identify candidates for further diagnostic testing. Use of this screening method may help minimize and slow the spread of contagious disease, and allows the user to operate the device at a greater distance from the patient than do forehead-reading thermometers.
Thermal imaging works via a two-part process: Cameras capture and measure infrared radiation emitted by a person, then connect to a visual display for real-time processing. Increases/decreases in skin surface temperature are visualized by pattern recognition software. A digital colorized heat map of the face can be easily evaluated to determine the existence of a possible underlying health condition via a monitor. UL Solutions evaluates the essential and accurate performance of the thermal imaging camera and its interoperability with the companion Software as a Medical Device(SaMD). We also provide related cybersecurity assessment as requested.
UL Solutions can help companies prepare for a US Food and Drug Administration (FDA) clearance conforming to the Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. Post pandemic, we can also complete necessary informative test reports to be submitted for 510(k) and other local regulatory review.
The FDA provides examples of software medical devices.
Why UL Solutions
UL Solutions can perform stability and drift testing, resulting in a comprehensive test report. This process typically takes two to three weeks between our biomedical lab-based engineers and the customer who supplies remote details through our secure network. We can also issue a UL Classification Mark and certificate of compliance or conformance after successful completion of testing.
- IEC 60601-1
- IEC 80601-2-59