This document specifies the requirements and methods for the clinical investigation of medical electrical (ME) equipment used to measure the body temperature in indirect measurement mode.
This document covers both intermittently and continuously measuring clinical thermometers.
NOTE 1        This document does not apply to clinical thermometers measuring the body temperature in direct measurement mode.
NOTE 2        For clinical thermometers in direct measurement mode determining the technical accuracy in accordance with ISO 80601-2-56:—1) is considered sufficient.
This document is applicable to clinical thermometers with claimed measurement time shorter than 60 seconds (for methods such as oral or rectal measurement), or shorter than 5 minutes (for methods such as axillary measurement), and which are treated as predictive type thermometers and fall under the scope of this document.
This document specifies additional disclosure requirements.
This document does not apply to the clinical investigation of a screening thermographs for human febrile temperature screening whose laboratory accuracy requirements are described in IEC 80601-2-59.
This document does not apply to pulmonary artery catheter for the determination of cardiac output by thermodilution.
NOTE 3        ISO 80601-2-56:—1) does include pulmonary artery catheter for the determination of cardiac output by thermodilution.