Abstract

This document specifies the requirements and methods for the clinical investigation of clinical thermometers used to measure the body temperature of human patients in indirect measurement mode. This document covers both intermittently and continuously measuring clinical thermometers. This document is not intended for clinical thermometers measuring the body temperature in direct measurement mode. NOTE 1 For clinical thermometers in direct measurement mode determining the technical accuracy in accordance with IEC 80601-2-56 is typically sufficient. NOTE 2 For clinical thermometers in direct measurement mode with measurement times shorter than 60 s (for oral or rectal measurement), or shorter than 5 min (for axillary measurement) further evidence might be necessary to show these measurement times can be achieved in practice. This document specifies additional disclosure requirements for clinical thermometers. 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

2023-03-20

WI

00205392

Planned document number

DIN EN ISO 12487

Project number

02703397

Responsible national committee

NA 027-06-02 AA - Clinical thermometer  

Responsible european committee

CEN/TC 205 - Non-active medical devices  

Responsible international committee

ISO/TC 121/SC 3/JWG 8 - Joint ISO/TC 121/SC 3-IEC/SC 62D WG: Clinical Thermometers