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IEC 60601-2-63-ed.1.0
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
STANDARD published on 19.9.2012
The information about the standard:
Designation standards: IEC 60601-2-63-ed.1.0
Publication date standards: 19.9.2012
SKU: NS-410759
The number of pages: 92
Approximate weight : 307 g (0.68 lbs)
Country: International technical standard
Category: Technical standards IEC
The category - similar standards:
Annotation of standard text 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.
These changes apply to this standard:
IEC 60601-2-63-ed.1.0/Amd.1
Change
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Amendment 1 - Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
(Amendement 1 - Appareils electromedicaux - Partie 2-63: Exigences particulieres pour la securite de base et les performances essentielles des appareils a rayonnement X dentaires extra-oraux)
Change published on 7.7.2017
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IEC 60601-2-63-ed.1.0/Amd.2
Change
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Amendment 2 - Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
(Amendement 2 - Appareils electromedicaux - Partie 2-63: Exigences particulieres pour la securite de base et les performances essentielles des appareils a rayonnement X dentaires extra-oraux)
Change published on 12.5.2021
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