GB 9706.265-2021 Medical electrical equipment—Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment (English Version)
Replacement: This section applies to the basic safety and essential performance of intraoral imaging dental X-ray machines and their main components, hereinafter referred to as ME equipment. The scope of this section is limited to X-ray machines containing high-voltage transformer components in the X-ray tube assembly. This section does not apply to dental X-ray machines for extraoral imaging. Note 1: The X-ray generator in a dental X-ray machine for intraoral imaging will always contain an X-ray combination handpiece. Therefore, in this section, the concept of X-ray tube assembly is replaced by X-ray combination head. Note 2: For example, the main components can be combined X-ray head and electronic X-ray image receiver. Note 3: Light-stimulated phosphor panels (tost imu lat edpho spho rp lates) and their readers (hardware and software) are not included in the scope of this standard, because they do not use electrical components in the patient environment, nor Not ME EQUIPMENT. Belongs to GB9706.263,
GB 9706.265-2021 Referenced Document
GB 9706.1-2020 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
GB 9706.103-2020 Medical electrical equipment—Part 1-3: General requirements for basic safety and essential performance—Collateral Standard: Radiation protection in diagnostic X-ray equipment
GB 9706.265-2021 history
2021GB 9706.265-2021 Medical electrical equipment—Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment