NEN-EN-IEC 60601-2-63/A2
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
active, Most Current
| Organization: | NEN |
| Publication Date: | 1 July 2021 |
| Status: | active |
| Page Count: | 20 |
| 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
NEN-EN-IEC 60601-2-63/A2
July 1, 2021
Medical electrical equipment - Part 2-63: 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...
November 1, 2019
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
Scope, object and related standards
1 The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment – Part 1: General requirements for basic safety and...
June 1, 2015
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
NEN-EN-IEC 60601-2-63 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...