Study on Applicable Standard of the Infrared Thermal Imager Based on Thermal Radiation Theory
QIAN Xueboa, DAI Yunqia, ZHANG Yuna, YANG Guojuana, LIU Boa, LI Libinb, CHEN Chenga
a. Department of Active Medical Device; b. Department of Technology, Tianjin Medical Devices Quality Supervision and Testing
Center, Tianjin 300384, China
Abstract：Objective The existing two relevant national standards, GB/T 19146-2010 Infrared Devices for Instant Screening of
Human Skin Temperature and GB/T 19665-2005 General Specification for Electronic Infrared Imaging Thermometer of Body Skin,
have obvious differences in performance requirements, but the difference in scope and definition is not very distinct, which leads to
improper adoption of standards by some manufacturers of infrared thermal imager. This directly affects the performance of this kind
of products in clinical application. This paper analyzed the correlation between the two standards to promote enterprises to correctly
adopt standards. Methods Based on the basic principle of infrared thermal imager, this paper compared the similarities and differences
between GB/T 19146-2010 and GB/T 19665-2005. Results The results showed that with different clinical applications, two standards
had different writing ideas, mainly in the laboratory error and consistency of temperature measurement. Conclusion Based on the
analysis of the performance test results of different products, the scope of application of the standard is clearly distinguished, and
reasonable suggestions for the relevant manufacturers are provided, as well as necessary references for the regulatory authorities.
钱学波a，戴云旗a，张赟a，杨国涓a，刘博a，李立宾b，陈成a. 基于热辐射原理的红外热像仪适用标准研究[J]. 中国医疗设备, 2023, 38(1): 20-24.
QIAN Xueboa, DAI Yunqia, ZHANG Yuna, YANG Guojuana, LIU Boa, LI Libinb, CHEN Chenga. Study on Applicable Standard of the Infrared Thermal Imager Based on Thermal Radiation Theory. China Medical Devices, 2023, 38(1): 20-24.
