Real Decreto número 65/94 de 21/01/1994, relativo a las exigencias de seguridad de los aparatos eléctricos utilizados en medicina y veterinaria. Boletín Oficial del Estado número 45 de 22/02/1994 Página 5696 (Marginal 4044)

This Spanish royal decree establishes the essential safety and performance requirements for electrical devices used in human and veterinary medicine. It aims to protect patients, operators, and the environment from electrical hazards and malfunctions during medical procedures. This regulation affects manufacturers, importers, and distributors of medical electrical equipment in Spain, ensuring that all such devices meet strict safety standards before being used in clinical settings.