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Normas BSI – AENOR
BS EN 60601-2-63:2015

BS EN 60601-2-63:2015

Medical electrical equipment. Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment

Fecha Anulación:
2019-10-21 /Withdrawn
Comité:
CH/62/2
Equivalencias internacionales:

EN 60601-2-63:2015

IEC 60601-2-63:2012

Resumen:
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.
Keywords:
Radiation hazards, Safety measures, Instructions for use, Occupational safety, Electron beams, Particle accelerators, X-ray apparatus, Electrical safety, Protected electrical equipment, Enclosures, Electric enclosures, Safety engineering, Leakage currents, Electrical medical equipment, Physiotherapy, Radiation protection, Medical equipment, Radiotherapy, Electrical equipment, Medical radiology, Electronic equipment and components
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