Validación de la Serie Cero del Termociclador TEMPER para su Aplicación en Laboratorios de Diagnóstico Molecular

摘要

An analysis of the performance characteristics and the technical requirements compliance of a new designed thermal cycler is presented in order to demonstrate that it can be successfully implemented for the intended application. The thermal cycler TEMPER is an instrument used in molecular diagnostic laboratories. The stages performed in the validation process of this device and the most important results obtained in validation tests are described, considering the compliance of international regulations for medical electrical equipment validation. Tests results are also compared with the requirements internationally reported at present for this kind of equipment.