Aspectos fundamentales para la acreditación de laboratorios de calibración de equipos médicos en Colombia

Abstract

Objective Analysing the fundamental methodological aspects which should be considered when drawing up calibration procedure for electro-medical equipment, thereby permitting international standard-based accreditation of electro-medical metrology laboratories in Colombia. Methods NTC-ISO-IEC 17025:2005 and GTC-51-based procedures for calibrating electro-medical equipment were implemented and then used as patterns. Results The mathematical model for determining the estimated uncertainty value when calibrating electro-medical equipment for accreditation by the Electrical Variable Metrology Laboratory's Electro-medical Equipment Calibration Area accredited in compliance with Superintendence of Industry and Commerce Resolution 25771 May 26th 2009 consists of two equations depending on the case; they are: Conclusion The mathematical modelling implemented for measuring uncertainty in the Universidad Tecnológica de Pereira's Electrical Variable Metrology Laboratory (Electro-medical Equipment Calibration Area) will become a good guide for calibration initiated in other laboratories in Colombia and Latin-America.