Needless to say, body temperature camera solutions are in high demand today amid covid-19. However, thermal cameras for temperature screening purposes are subject to certain requirements, which must be followed by manufacturers and users.
Needless to say, body temperature camera solutions
are in high demand today amid covid-19. However, thermal cameras for temperature screening purposes are subject to certain requirements, which must be followed by manufacturers and users.
Covid-19 has created a huge impact to communities across the globe, infecting millions and killing tens of thousands. This has prompted more and more end user entities, especially those seeking to cautiously reopen their businesses, to
deploy body temperature cameras as a solution for screening fever – a major symptom of covid-19.
Given the rise in demand, manufacturers are quick to develop and market these cameras to users who need them. Similarly, many end users are already using thermal cameras at their entities, for example factories, for
industrial or perimeter detection purposes. It’s naturally tempting for them to turn to their existing thermal cameras for fever screening.
However, there are certain requirements, some issued by regulatory bodies, regarding the manufacture, marketing and usage of these devices. Violating these rules may put manufacturers and users at risk of product recalls or fines. Some of these requirements are examined as follows.
Body temperature camera requirements by USFDA
According to the US Food and Drug Administration, when used in non-medical applications, such as in construction and other industrial applications, “telethermographic systems” including body temperature cameras may be sold without FDA marketing authorization. When used for medical purposes, such as measurement of the self-emanating infrared radiation that reveals the relative temperature variations of the surface of the body, telethermographic systems must be evaluated by the FDA which will consider whether: 1) they are labeled or otherwise intended for use by a health care professional; 2) they are labeled or otherwise for use in a health care facility or environment; and 3) they are labeled for an intended use that meets the definition of a device, for example body temperature measurement for diagnostic purposes.
In most cases, body temperature cameras are used for adjunctive screening – that is, the camera only pre-screens individuals for higher body temperatures; once detected the individual will then be examined via real medical devices. According to FDA, manufacturers of telethermographic systems intended for adjunctive diagnostic screening are required to submit a premarket notification, pursuant to section 510(k) of the Food, Drug and Cosmetic Act, to FDA and receive FDA clearance prior to marketing these devices in the United States, as well as comply with postmarketing requirements.
Guidelines from ISO
For the setup and installation of cameras, installers and users may refer to ISO 13154:2017, which provides general guidelines for the deployment, implementation and operation of a screening thermograph intended to be used for non-invasive febrile temperature screening of individuals under indoor environmental conditions to prevent the spread of infection.
According to FLIR Systems, if user is seeking to set up their body temperature camera systems with a blackbody, they may follow the following 13154:2017 guidelines: The camera of the screening thermograph should be positioned perpendicular, both horizontally and vertically, to the face of the individual being screened so that the inner corner of both eyes can be imaged simultaneously; the individual being screened and the external temperature reference source should be in the correct position and orientation relative to the camera for proper focal distance, depth of field and image capture; and there should be a means of ensuring that the individual being screened is in this proper position.
Meanwhile, it should be noted that production of body temperature cameras must be in according to EU standards, ISO 9001 or equivalent. ISO 9001 sets out the criteria for a quality management system and is based on a number of quality management principles.