IEC-60601-2-63 Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment

IEC-60601-2-63 - EDITION 1.2 - CURRENT
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IEC 60601-2-63:2012+A1:2017+A2:2021 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.
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11.040.50 (Radiographic equipment Including radiographic diagnostic and therapy equipment Dental, medical and industrial radiographic films, see 37.040.25)

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Document Number

IEC 60601-2-63 Ed. 1.2 en:2021

Revision Level

EDITION 1.2

Status

Current

Publication Date

May 1, 2021

Committee Number

62B