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Reference IEC 60601-2-63 ed1.0 withdrawn corrigendum
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Title Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
Publication date 2012-09-19
Format, price
(Swiss francs)
and language
230.- 92 pages
230.- 1827 Kb
 
Abstract 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.
Technical Committee 62B - Diagnostic imaging equipment  RSS
ICS Codes
11.040.50 Radiographic equipment
*Including radiographic diagnostic and therapy equipment
*Dental, medical and industrial radiographic films, see 37.040.25
 
Replaced by
Stability date 2018
 
Work in progress
ProjectStage codeForecast publication date
No project under development--


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