Catalog of Regulatory Science Tools to Help Assess New Medical Devices
This regulatory science tool presents a lab method for objective, quantitative assessment of infrared thermographs (IRTs) performance based on IEC 80601-2-59: 2017 [1]. Please see appendix.
Technical Description
Methods for evaluating stability and drift, image uniformity, minimum resolvable temperature difference, and radiometric temperature laboratory accuracy of IRTs are described in detail in peer-reviewed publication [2].
IRTs have been used for initial temperature assessment and triage of individuals for elevated temperatures in medical and non-medical environments. To achieve good accuracy, qualified IRT systems should be used, and appropriate procedures should be consistently applied. This tool provides methods for testing IRT laboratory accuracy which can enhance the methods in the international standard [1].
The tool may improve the utility of IRTs and aid in comparing IRT performance, thus improving the potential for producing high-quality countermeasures during infectious disease outbreaks.
Intended Purpose
The tool is intended for evaluation of IRT laboratory accuracy. It enables, streamlines, or otherwise improves verification, validation and quality control during design, development and manufacturing of IRTs. The testing described in this tool should be performed by persons with engineering background in thermography.
Testing
The method has been tested on two infrared cameras (A325sc, FLIR Systems Inc.; 8640 P-series, Infrared Cameras Inc.). Details are described in our publication [2].
Limitations
- This tool is for IRTs that capture whole face thermal images. Therefore, there are requirements for camera configuration (for example, pixel number).
- This tool can only be used to evaluate IRT laboratory accuracy. A complete assessment of IRT performance should also include clinical accuracy evaluation as described in a publication [3]
- This tool is not intended for evaluating laboratory accuracy of some temperature scanner kiosks that identify the region of interest (ROI) with a visible light camera and to measure the ROI temperature with an infrared sensor with limited number of pixels. However, methods for evaluating those devices might be derived from this tool.
Supporting Documentation
- This tool enhances the test methods found in the IEC 80601-2-59: 2017 standard [1] for evaluating the stability and drift, image uniformity, minimum resolvable temperature difference, and radiometric temperature laboratory accuracy of IRTs. The standard provides an overview of test methods as well as background information such as scope, definitions, testing equipment, procedure, and hazard.
- Scientific details about the tool can be found in our publication [2].
- A comparison of the enhanced methods provided by this tool with the methods specified in the standard can be found in the appendix.
Contact
Tool Reference
- In addition to citing relevant publications please reference the use of this tool using RST24MD07.01
Note: This tool was previously listed in the catalog as “Laboratory accuracy evaluation of infrared thermographs.”