Comitato Elettrotecnico Italiano

Medical electrical equipment Part 2: Particular requirements for basic safety and essential performance of dental extra-oral x-ray equipment
 N EN 60601-2-63

Annotation

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 such ME EQUIPMENT.

NOTE 1 This includes PANORAMIC equipment, CEPHALOMETRIC equipment, and equipment for dental volumetric reconstruction (hereafter DVR) as defined in 201.3.203 below.

NOTE 2 DVR includes dental CBCT (cone beam computed tomography), which is also known with other names in certain parts of the world, e.g. DVT (digital volumetric tomography); DVR also includes tomosynthesis.

NOTE 3 This may include the imaging of other anatomical parts (e.g. the hand) as long as required for dental treatment (e.g. orthodontic treatment).

NOTE 4 This may include anatomical objects of interest to the ENT (ear, nose, and throat) specialist.

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.

NOTE 5 DENTAL INTRA-ORAL X-RAY EQUIPMENT is excluded from the scope of this standard.

NOTE 6 FOCAL SPOT TO IMAGE RECEPTOR DISTANCE and FOCAL SPOT to object distance are preset in the design of DENTAL EXTRA-ORAL X-RAY EQUIPMENT.