Popis: |
In Argentina, electromedical devices may only be commercialized if they meet safety and performance requirements established by current regulations, ensuring their safety and intended performance when leaving the Factory. However, during usage, natural wearing and overloading may change this condition, especially if used in extra hospital services performed by ambulances, which are likely to be subjected to rough handling conditions and hitting. This proposal explains the chosen methodology to address the periodic verification activities of electro medical devices within the process of terrestrial Technical Ambulance Inspection (TAI). Among the results stand out the set of methods for verification and the lists used to record the outcome of this evaluation. Outstanding conclusions include that the operations meet the conditions of an analogous mechanism to that of a Technical Vehicle Inspection (existing for other vehicles), and that the same working structure can be used as a basis for making a manual of procedures for a TAI. |