Pioneering Project: SIQ Verifies Safety and Performance of Clinical Thermometers According to ISO/EN 80601-2-56

SIQ has successfully completed its first pilot project on the safety of clinical thermometers for body temperature measurement in accordance with the ISO 80601-2-56:2017 + A1:2018 (EN 80601-2-56:2017 + A1:2020) standard – Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.

The project was carried out in cooperation with the Faculty of Electrical Engineering (Laboratory for Metrology and Quality). Both contact thermometers and infrared (IR) thermometers were tested in all operating modes and under all required environmental conditions. As specified by the standard, reference temperature sources were used — a fluid bath for contact thermometers and a black body source for IR thermometers.

From a testing perspective, contact measurement proved more straightforward, while the IR mode presented more challenges, particularly regarding accuracy. The critical requirement was to achieve laboratory accuracy within ±0.4°C, as mandated by ISO/EN 80601-2-56. This level of precision was successfully achieved using calibrated test equipment, including supporting instruments available at the Faculty’s accredited laboratory (Slovenian Accreditation, SA), which is authorised for such high-accuracy measurements.

More information:
Janez Vidmar
E-mail: janez.vidmar@siq.si
Tel.: +386 1 4778 262