ANALYSIS OF GAPS IN STANDARDIZATION IN METROLOGICAL TRACEABILITY FOR MEDICAL DEVICES: CASE OF CLINICAL THERMOMETERS, ULTRASOUNDS AND SHORTWAVE

Abstract

The metrology or study of the measures, it was found at all levels of the reality of the society. The correct measure requires that international organizations that establish the market rules and the quality of life, defined what and how they´re obtained. To this end, there is the international system of units and the International Bureau of Weights and Measures (IBWM), which define the units and to carry out experiments. Making that countries can recourse for a metrological traceability that guarantees all the variables that are used in the world. In the daily lives of the people there are multitude of magnitudes that are measured with a determined accuracy, as the water pressure or the electricity power. The calibrations are the processes for verifying the accuracy of the measures, by means of accuracy. The processes of calibration and verification of the magnitudes should be reproducible. The unified standards are documents that under the international recognition and with the participation of all the officers involved have been developed to establish a series of common requirements for which there is a compatibility in everything that is manufactured. There must be rules establishing the metrological traceability of measures or magnitudes, ensuring any measure or magnitude. In this set of rules have to be dealt with the magnitudes and medical measures, taking its relevant standardization. By time has not been a specific study with the standardization in terms of metrological traceability for medical equipment. This article aims to give a response to the situation for the clinical thermometers, ultrasound, and shortwave. Keywords: Electromedicine, medical unit, traceability, metrology, biomedicine, UNE rule.