IEC 60601-2-65:2012+A1:2017+A2:2021适用于口腔内X射线设备及其主要部件的基本安全和基本性能。本标准的范围仅限于X射线管组件包含高压变压器组件的X射线设备。牙科口腔外X射线设备不在本标准范围内。本特殊标准旨在根据IEC 60601-1:2005及其附属标准，为口腔内X射线设备提供一整套基本安全和基本性能要求。虽然之前针对此类设备的现有标准专门针对组件和子系统，但该特定标准针对口腔内X射线设备的系统级。组件及其功能将在必要时予以说明。

IEC 60601-2-65:2012+A1:2017+A2:2021 applies to the basic safety and essential performance of dental intra-oral X-ray equipment and its main components. The scope of this standard is restricted to X-ray equipment where the X-ray tube assembly contains the high-voltage transformer assembly. Dental extra-oral X-ray equipment is excluded from the scope of this standard. This particular standard has been prepared to provide, based on IEC 60601-1:2005 and its collaterals, a complete set of basic safety and essential performance requirements for dental intra-oral X-ray equipment. While the previously existing standards for such equipment were dedicated to components and subsystems, this particular standard addresses the system level of dental intra-oral X-ray equipment. Components and their functions are addressed as far as necessary.