GB 9706.263-2020
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment (English Version)

Standard No.

GB 9706.263-2020

Language

Chinese, Available in English version

Release Date

2020

Published By

国家市场监督管理总局、中国国家标准化管理委员会

Latest

GB 9706.263-2020

Scope

This section applies to the basic safety and basic performance of extraoral imaging dental X-ray machines (hereinafter referred to as X-ray machines). The scope includes ME SYSTEMS containing such ME EQUIPMENT. Note 1: This includes oral surface tomographic equipment, cephalometric equipment and dental volume reconstruction equipment (hereinafter referred to as DVR) defined in 201.3.203. Note 2: DVR includes dental (cone beam computed tomography), also known by other names in some areas, e.g., DVT (digital volume tomography); DVR also includes tomosynthesis imaging. Note 3: This may include imaging of other anatomical parts (e.g., hands) required for dental treatment (e.g., orthodontic treatment). Note 4: This may include imaging of anatomical areas of interest to the ENT (ear, nose, and throat) specialist. The scope of this section is limited to the following radiographic equipment: 　——Ray tube assemblies containing high-voltage transformer components and——The geometric relationship between the radioactive source, the desired imaging part of the patient, and the x-ray image receiver is predetermined, And within the intended use, the operator cannot arbitrarily change it. Note 5: Dental X-ray machines for intraoral imaging are not within the scope of this standard. Note 6: The distance from the focus to the image receiver and the distance from the focus to the subject are preset in the extraoral imaging dental X-ray machine. Note 7: Due to the above restrictions, dental X-ray machines that are not within the scope of this part can use the applicable provisions of IEC60601254 together with this part. Equipment and ME systems falling within the scope of GB9706.18, IEC60601254, GB9706.24, IEC60601265 or GB9706.23 are not within the scope of this special standard. The scope of this section also does not include radiation therapy simulation equipment and equipment for bone or tissue absorption density, nor does it include dental fluoroscopy equipment. Within the specified scope, the provisions of this special standard will supersede and replace GB9706.3-2000 "Medical Electrical Equipment Part 2: Special Requirements for Safety of High-Voltage Generators for Diagnostic X-ray Generating Devices" and GB9706.14-1997 "Medical Electrical Equipment" Equipment Part 2: Special safety requirements for X-ray equipment ancillary equipment. Note 8: The requirements for X-ray generating devices and ancillary equipment, namely GB9706.3 and GB9706.14 explained previously, have been included in GB9706.1-2020 or special standards. Therefore, GB9706.3 and GB9706.14 are not applicable to the part of the GB9706 standard system to which extraoral imaging dental radiographs belong. All requirements for combined X-ray tube assemblies are covered by this part, so unless the ray tube assembly is replaceable, GB9706.11 does not apply to ME equipment specified in this special standard. Note 9: The requirements for dental X-ray machines in the previous version of the parallel standard GB9706.12 and the special standard GB9706.11 have been extracted and included in this section. Note 10: The X-ray tube assembly of the X-ray equipment described within the scope of this special standard refers to the X-ray combined handpiece.

GB 9706.263-2020 history

• 2020 GB 9706.263-2020 Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment

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