Abstract

SALAZAR GOMEZ, Antonio José  and  CUERVO RAMIREZ, Diana Katherine. Test Protocol for Electrical Safety in Electrical Medical Equipment: Case Study for Telemedicine Equipment. rev.ing. [online]. 2013, n.38, pp.27-32. ISSN 0121-4993.

The Colombian National Food and Drug Institute regulations (Instituto Nacional de Vigilancia de Medicamentos y Alimentos - INVIMA) covering the electrical safety of imported and Colombian-made medical devices are inadequate to the task. Consequently, the Colombian Institute for Technical Standards and Certification (the Instituto Colombiano de Normas Técnicas y Certificación - ICONTEC) adopted relevant international norms such as NTC-IEC 60601-1. The authors examined this standard and established a pilot protocol to evaluate the degree to which locally and foreign made electronic telemedicine devices complied with its terms. The draft protocol was tested on several tele-medicine devices and represents an important contribution to the Colombian biomedical engineering sector

Keywords : Medical electrical equipment; IEC 60601-1; INVIMA; electrical safety.

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