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DIN Standards Committee Optics and Precision Mechanics

Abstract

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.

Begin

2023-03-01

WI

00205392

Planned document number

FprEN ISO 12487

Responsible national committee

NA 027-06-02 AA - Clinical thermometer  

Responsible european committee

CEN/TC 205 - Non-active medical devices  

draft standard

Medical electrical equipment - Clinical performance evaluation of clinical thermometers (ISO/FDIS 12487:2026)
2026-03
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