Decreto ministeriale del 28/11/1987 n. 597, attuazione della direttiva n. 84/539/CEE, relativa agli apparecchi elettrici utilizzati in medicina umana e veterinaria, Supplemento ordinario n. 33 alla Gazzetta Ufficiale - Serie generale - del 20/04/1988 n. 92

This decree implements EU Directive 84/539/EEC, establishing safety and technical standards for electrical devices used in human and veterinary medical practice. It ensures that medical equipment meets specific health and safety requirements to protect both patients and practitioners. This regulation affects manufacturers, distributors, and healthcare providers of medical electrical equipment operating within Italy.