Features of technical regulation concerning medical infrared thermometers
- 1SE «Kharkiv regional research and production center for standardization, metrology and certification», Kharkiv, Ukraine
- 2Ukrainian Engineering and Pedagogical Academy, Kharkiv, Ukraine
Summary. The analysis of the development and current state of state technical regulation concerning medical infrared thermometers, the widespread use of which is currently due to the COVID-19 pandemic, is carried out. The stages of development of technical regulation are conditionally attributed to certain time periods — until 2016 (stage 1), from 2016 to 2020 (stage 2) and from 2020 to the present (stage 3). The problematic aspects of testing according to conformity assessment procedures in terms of the requirements for the metrological characteristics of medical devices with a measurement function as well as the features of the terminological specification of the types of medical thermometers in the relevant regulatory and legal documents at each stage of development are highlighted. The state of the normative base and the corresponding information resources are considered from the point of view of their completeness and availability for consumers. The issue of periodic metrological control of medical infrared thermometers, which during a pandemic can be provided on the Ukrainian market according to procedures alternative to the requirements of the Technical Regulations for medical devices, is raised.
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