IEC - 60601-2-63 AMD 2
AMENDMENT 2 Medical electrical equipment – Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
| Organization: | IEC |
| Publication Date: | 1 May 2021 |
| Status: | inactive |
| Page Count: | 12 |
| ICS Code (Radiographic equipment): | 11.040.50 |
scope:
NOTE 1 An example of such equipment is an equipment designed to perform PANORAMIC, CEPHALOMETRIC and DENTAL VOLUMETRIC RECONSTRUCTION (hereafter DVR) as defined in 201.3.203.
DENTAL EXTRA-ORAL X-RAY EQUIPMENT are X-RAY EQUIPMENT designed for EXTRA-ORAL RADIOGRAPHY in which 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. In such equipment, the X-RAY TUBE ASSEMBLY contains the HIGH-VOLTAGE TRANSFORMER ASSEMBLY.
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