UNE EN 60601-2-63:2015/A2:2021
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment (Endorsed by Asociación Española de Normalización in August of 2021.)
Equipos electromédicos. Parte 2-63: Requisitos particulares para la seguridad básica y el funcionamiento esencial de los equipos de rayos X dentales extraorales (Ratificada por la Asociación Española de Normalización en agosto de 2021.)
| Standard number: | UNE EN 60601-2-63:2015/A2:2021 |
| Pages: | 17 |
| Released: | 2021-08-01 |
| Status: | Amendment |
UNE EN 60601-2-63:2015/A2:2021
After the second paragraph add the following new paragraph: 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. Replace Note 1 with the following text: 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 below. Replace the third but last paragraph, between Note 8 and Note 9, with the following text: All requirements addressing integrated X-RAY TUBE ASSEMBLIES are covered by this particular standard. Therefore IEC 60601-2-28 does not apply to ME EQUIPMENT in the scope of this International Standard with the exception of X-RAY TUBE ASSEMBLIES that are replaceable in the field by entities other than the manufacturer.
