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[Fundamental aspects for accrediting medical equipment calibration laboratories in Colombia]
Luis E Llamosa-Rincón1, Giovanni A López-Isaza, Milton F Villarreal-Castro
1Facultad de Ciencias Básicas, Departamento de Física, Universidad Tecnológica de Pereira, Colombia.
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: E = (Ai + sigmaAi) - (Ar + sigmaAr + deltaAr1) and E = (Ai + sigmaAi) - (Ar + sigmaA + deltaAr1).
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.
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