• IEC 60601-2-63 Ed. 1.2 en:2021

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

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

International Electrotechnical Commission, 05/12/2021

Publisher: IEC

File Format: PDF

$234.00$468.00


Published:12/05/2021

Pages:95

File Size:1 file , 1.7 MB

Note:This product is unavailable in Ukraine, Russia, Belarus

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. This consolidated version consists of the first edition (2012) and its amendment 1 (2017) and amendment 2 (2021). Therefore, no need to order amendment in addition to this publication.
 

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