Medical electrical equipment – Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
|Publication Date:||1 October 2008|
|ICS Code (Diagnostic equipment):||11.040.55|
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SCREENING THERMOGRAPHS intended to be used for the individual non-invasive febrile temperature screening of humans under indoor environmental conditions, hereafter referred to as ME EQUIPMENT. This International Standard sets laboratory characterization test limits for the SCREENING THERMOGRAPH.
NOTE A SCREENING THERMOGRAPH is intended for screening and detection of human subjects with SKIN TEMPERATURES elevated above normal. An elevated SKIN TEMPERATURE needs to be followed up by a subsequent temperature measurement using a clinical thermometer (see IEC 80601-2-56).
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.