Appareils électromédicaux – Partie 2-63 : Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X dentaires extra-oraux

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.

NOTE 7 For DENTAL X-RAY EQUIPMENT not in the scope of this document because of the restriction above, applicable clauses of IEC 60601-2-54 may be used with this document.

ME EQUIPMENT and ME SYSTEMS in the scope of IEC 60601-2-44, IEC 60601-2-54, IEC 60601-2-45, IEC 60601-2-65 or IEC 60601-2-43 are excluded from the scope of this particular standard. The scope of this International Standard also excludes RADIOTHERAPY SIMULATORS and equipment for bone or tissue absorption densitometry. Excluded from the scope is also ME EQUIPMENT intended to be used for DENTAL RADIOSCOPY.