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Publication details

Publication CODE Title
IEC 60601-2-63:2012+AMD1:2017 CSV (2017-07) MEDICAL ELECTRICAL EQUIPMENT - PART 2-63: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EXTRA-ORAL X-RAY EQUIPMENT
 
Price Excl. VAT Total number of pages, tables and drawings
408.00 € 184.
Description
IEC 60601-2-63:2012+A1:2017 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). Therefore, no need to order amendment in addition to this publication.
Class  C990  (IEC PUBLICATIONS IEC PUBLICATIONS)
Available files
EN/FR version

Status
Status IEC PUBLICATION
Situation Currently active
Origin
Committee TC 62/SC 62B
DIAGNOSTIC IMAGING EQUIPMENT
Approval
BEC Approval 2017-07-07
ICS-Code (International Standards Classification) 11.040.50
NBN Status New
IEC publication date 2017-07-07
IEC stability date 2020-12-31
IEC file modification date 2017-07-07
IEC last modification date 2020-01-02