DIN Standards Committee Optics and Precision Mechanics
Respiratory equipment - Clinical investigation of clinical thermometers
Abstract
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.
Begin
2023-03-01
WI
00205392
Planned document number
prEN ISO 12487
Responsible national committee
NA 027-06-02 AA - Clinical thermometer
