Elaboración de un protocolo para calibración de equipos de pesaje no automático y esfigmomanómetros bajo los lineamientos de la norma NTC/ISO-IEC 17025:2017

Abstract

The calibration of biomedical equipment classified as measuring instruments must be currently performed by accredited laboratories, as specified in Decree 1595 of 2015 that regulates legal metrology in Colombia. The goal is to ensure that the optimal operation of the technology and that the patient's safety is not compromised. Based on this, the present investigation aims to develop a protocol for calibration of biomedical equipment, specifically non-automatic weighing instruments as well as mechanical and automatic sphygmomanometers under the guidelines of the Colombian technical standard NTC / ISO-IEC 17025 General Requirements for the competence of the 2017 testing and calibration laboratories. To achieve this objective, it was necessary to review the literature guides SIM MWG7 / cg-01 / v.00 of 2009, OIML R16-1 and R16-2, which are the basis for the elaboration of the proposed protocol. In addition, the advisor of the National Accreditation Agency of Colombia provided training sessions - ONAC hired by the institution in the process of accreditation, where all the analyses were performed. These trainings focused on strengthening the competence of the personnel involved, such as basic statistics, measurement uncertainty, mass internship, pressure internship; which allowed them to acquire the theoretical and related technical bases in the elaboration of a protocol that can be adopted by any calibration laboratory.