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. 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 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) are treated as predictive type thermometers and fall under the scope of this standard. 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

2023-03-20

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  

draft standard

Medical electrical equipment - Clinical performance evaluation of clinical thermometers (ISO/DIS 12487:2024); German and English version prEN ISO 12487:2024
2025-01
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previous edition(s)

Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017 + Amd1:2018); German version EN ISO 80601-2-56:2017 + A1:2020
2020-08

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