scope:

Replacement: 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 101 This includes panoramic equipment, cephalometric equipment, and equipment for Dental Volumetric Reconstruction (hereafter DVR) as defined in 201.3.203 below. NOTE 102 DVR is variously known in different parts of the World as CBCT (Cone Beam Computed Tomography), DVT (Digital Volumetric Tomography), and other names. DVR includes tomosynthesis. NOTE 103 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 104 This may include anatomical objects of interest to the ENT (Ear, Nose, and Throat) specialist. Excluded from the scope of this standard is X-RAY EQUIPMENT where: - HIGH-VOLTAGE parts are accessible in normal use. - the geometrical relations between the X-RAY source, the anatomical object being imaged in the PATIENT, and the X-RAY RECEPTOR, are not preset in the design and can be arbitrarily altered by the operator during INTENDED USE. NOTE 105 DENTAL INTRA-ORAL X-RAY EQUIPMENT is excluded from the scope of this standard NOTE 106 FOCAL SPOT TO IMAGE RECEPTOR DISTANCE and FOCAL SPOT to Object Distance are preset in the design of DENTAL EXTRA-ORAL X-RAY EQUIPMENT. 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. NOTE 107 Requirements for X-RAY GENERATORS and for ASSOCIATED EQUIPMENT, which were previously specified in IEC 60601-2-7 and IEC 60601-2-32, have been included in either IEC 60601-1:2005 (Ed3) or this particular standard. Therefore IEC 60601-2-7 and IEC 60601-2-32 are not part of the IEC 60601-1 3rd edition scheme for DENTAL EXTRA-ORAL X-RAY EQUIPMENT.