The Gradual Standardization of Infrared Camera Parameters

The Gradual Standardization of Infrared Camera Parameters

   Body temperature detection is the field where medical infrared thermal imaging camera technology is the first to achieve standardization. Epidemics such as SARS, influenza, bird flu, and tuberculosis pose a huge threat to global health. Large-scale testing of patients with fever is the most effective way to control the spread of these epidemics. In order to curb the inconsistent reporting results during SARS, standardization work is imperative. Therefore, the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) established a joint working group to formulate two documents to regulate the design, development and use of infrared cameras for body temperature detection.

   The first document is the international standard IEC80601-2-59:2008 "Medical Electrical Equipment Part 2-59: Specific Requirements for the Basic Safety and Performance of Thermal Imaging Cameras Used for Human Body Heating Temperature Screening". This international standard is applicable to the basic safety and performance of screening thermal imaging cameras for non-invasive body temperature screening under indoor conditions. As a supplement to IEC60601-1-1, this special standard has revised and added 23 specific items for the five chapters of random files, controller and instrument accuracy, programmable medical electrical system connection, measurement accuracy, and alarm status. Test items to specify the minimum performance and safety requirements of infrared thermal imaging cameras for human body temperature detection.

   The second document is the ISO Technical Report ISO/TR13154:2017 "Guidelines for the Arrangement, Implementation and Operation of Medical Electrical Equipment Using Screening Thermal Imaging Cameras to Identify Fevering Human Body. This document is detailed from nine aspects of screening site conditions, screening process planning, selection of screening thermal imaging cameras, system settings, screening plans, interpretation of screening results, operator requirements, responsible agency requirements, data storage and security. Explains the guidelines for the use of equipment complying with IEC 80601-2-59:2008 for body temperature detection. The report puts forward strict operating protocols and guidelines to facilitate the reliable and repeated use of thermal imaging cameras for large-scale body temperature detection of fever.

Figure 1. Infrared thermal imaging technology.

   In 2017, the new version of the "Medical Device Classification Catalogue" issued by the former State Food and Drug Administration classified "Medical Infrared Cameras" into the second-level sub-category "Second Optical Imaging" under the first-level product category "In Medical Imaging Devices" In "Diagnostic Equipment", the management category is Class II. The product function is defined as "used to measure the temperature distribution on the surface of the human body and provide an infrared thermal image." At present, the performance indicators in the technical requirements of medical infrared thermal imaging products are mainly based on GB/T19665-2005 "General Specification for Electronic Infrared Imaging Human Surface Thermometers". Recently, the Zhejiang Safety Technology Protection Industry Association issued an industry standard, which is T/ZJAF3-2020 "Technical Specification for Thermal Imaging Human Body Temperature Measurement Alarm System". The "Specifications" stipulate the construction principles, system classification and architecture, functional requirements, performance requirements, application environment requirements, operation and maintenance requirements for thermal imaging human body temperature measurement alarm systems. It is suitable for the scheme design, system inspection and acceptance of thermal imaging human body temperature measurement alarm system used in public places, as well as the development and production of related equipment.