CEI - EN 60601-2-63/A2
Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
active, Most Current
| Organization: | CEI |
| Publication Date: | 1 March 2022 |
| Status: | active |
| Page Count: | 16 |
| 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.
Document History
EN 60601-2-63/A2
March 1, 2022
Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
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...
April 1, 2020
Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
A description is not available for this item.
June 1, 2016
Medical electrical equipment Part 2: Particular requirements for basic safety and essential performance of dental extra-oral x-ray equipment
This International Standard 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...