IEC 60601-2-63-ed.1.0

Anotace textu normy IEC 60601-2-63-ed.1.0 :

IEC 60601-2-63:2012 applies to the basic safety and essential performance of dental extra-oral X-ray equipment, hereafter also called ME equipment. The scope includes ME systems containing such ME equipment. This particular standard has been prepared to provide, based on IEC 60601-1:2005 and its collaterals, a complete set of basic safety and essential performance requirements for dental extra-oral x-ray equipment. While the previously existing standards for such equipment were dedicated to components and subsystems, this particular standard addresses the system level of dental extra-oral x-ray equipment. Components and their functions are addressed as far as necessary. The scope of this standard is restricted to X-ray equipment where: - the x-ray tube assembly contains the high-voltage transformer assembly; and - the geometrical relations between the X-ray source, the anatomical object being imaged in the patient, and the X-ray image receptor, are preset in the design and cannot be arbitrarily altered by the operator during intended use. La CEI 60601-2-63:2012 sapplique a la securite de base et aux performances essentielles des appareils a rayonnement X dentaires extra-oraux, egalement designes ci-apres par appareils EM. Le domaine dapplication inclut les systemes EM contenant de tels appareils EM. La presente norme particuliere a ete preparee pour fournir, sur la base de la CEI 60601-1:2005 et de ses normes collaterales, un ensemble complet dexigences de securite de base et de performances essentielles pour les appareils a rayonnement x dentaires extra-oraux. Alors que les normes anterieures pour de tels appareils etaient consacrees aux composants et aux sous-systemes, la presente norme particuliere concerne le niveau systeme des appareils a rayonnement x dentaires extra-oraux. Les composants et leurs fonctions sont mentionnes dans la mesure ou cela est necessaire. Le domaine dapplication de la presente norme est limite aux appareils a rayonnement X dans lesquels: - la gaine equipee contient lensemble transformateur haute tension; et - les relations geometriques entre la source de rayonnement X, lobjet anatomique soumis a limagerie chez le patient et le recepteur radiologique sont prereglees au niveau de la conception et ne peuvent pas etre modifiees de facon arbitraire par loperateur pendant lutilisation prevue.