GB/T 19042.7-2025 Evaluation and routine testing in medical imaging departments—Part 3-7:X-ray equipment for dental cone beam computed tomography imaging performance acceptance and constancy tests
GB/T 19042.7-2025 Evaluation and routine testing in medical imaging departments—Part 3-7:X-ray equipment for dental cone beam computed tomography imaging performance acceptance and constancy tests
Basic Information
Scope
This document applies to oral and maxillofacial cone-beam computed tomography (CBCT) X-ray equipment (hereinafter referred to as oral CBCT equipment) in accordance with the GB 9706.263-2020 standard.
Note 1: Oral CBCT equipment is a subcategory of extraoral imaging dental X-ray machines.
Note 2: Extraoral imaging dental X-ray machines can provide one or more imaging modes, including panoramic, cephalometric, tomographic, and oral CBCT, all of which fall within the scope of the GB 9706.263 basic safety and performance standards.
This document applies to the acceptance and stability tests of the imaging performance of oral and maxillofacial cone-beam computed tomography X-ray equipment.
The purpose of the acceptance test is to verify whether the installation or major maintenance meets the standards affecting image quality, radiation output, and patient positioning.
The provisions in this document are minimum requirements. Manufacturers may set testing standards exceeding the requirements of this document.
The stability test is conducted to ensure that the functional performance of medical electrical equipment (ME equipment) meets established standards, to detect changes in the performance of ME equipment components in a timely manner, and to verify compliance with the standards affecting image quality, radiation output, and patient positioning.
This document also includes requirements for accompanying documents related to the acceptance and stability tests of oral CBCT equipment.