This document specifies the requirements and methods for the clinical investigation of ME equipment used to measure the body temperature in indirect measurement mode.
This document covers both intermittently and continuously measuring clinical thermometers.
NOTE For clinical thermometers in direct measurement mode determining the technical accuracy in accordance with IEC 80601-2-56 is typically sufficient.
This document specifies additional disclosure requirements.
This document is not applicable to the clinical investigation of a screening thermographs for human febrile temperature screening whose laboratory accuracy requirements are described in IEC 80601-2-59.