Test Protocol for Electrical Safety in Electrical Medical Equipment: Case Study for Telemedicine Equipment

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 telemedicine devices and represents an important contribution to the Colombian biomedical engineering sector.