GB 9706.263-2020 Active

This part applies to the basic safety and basic performance of extraoral imaging dental X-ray machines (hereinafter referred to as ME devices). The scope includes ME systems containing such ME devices.
Note 1: This includes oral CBCT (cone beam computed tomography) devices, cephalometric measurement devices, and dental volume reconstruction devices (hereinafter referred to as DVR) defined in 201.3.203.
Note 2: DVR includes dental CBCT (cone beam computed tomography), which is also known as DVT (digital volume tomography) in some regions; DVR also includes tomographic synthesis imaging.
Note 3: This may include imaging of other anatomical regions (such as the hand) required for dental treatment (e.g., orthodontic treatment).
Note 4: This may include imaging of anatomical regions of interest to ENT (ear, nose, throat) specialists.
The scope of this part is limited to the following X-ray devices:
-- X-ray tube assemblies containing high-voltage transformer components and
-- The geometric relationship between the X-ray source, the patient's required imaging area, and the X-ray image receiver is predefined, and in the intended use, the operator cannot arbitrarily change it.
Note 5: Intraoral imaging dental X-ray machines are not within the scope of this part.
Note 6: The distance from the focal point to the image receiver and the distance from the focal point to the imaging object are predefined in extraoral imaging dental X-ray machines.
Note 7: Due to the above restrictions, dental X-ray machines not within the scope of this part can use the applicable provisions of IEC 60601-2-54 in conjunction with this part.
ME devices and ME systems within the scope of GB 9706.18, IEC 60601-2-54, GB 9706.24, IEC 60601-2-65, or GB 9706.23 are not within the scope of this dedicated standard. The scope of this part also does not include radiation therapy simulation devices and devices for bone or tissue absorption densi