IEC 60601-2-63:2012+A1:2017+A2:2021适用于牙科口外X射线设备（以下也称为ME设备）的基本安全性和基本性能。范围包括包含此类ME设备的ME系统。本特定标准基于IEC 60601-1:20 05及其附属文件，为牙科口外x射线设备提供了一套完整的基本安全和基本性能要求。虽然此类设备的先前存在的标准专用于组件和子系统，但该特定标准针对牙科口外x射线设备的系统级别。必要时讨论组件及其功能。本标准的范围仅限于X射线设备，其中: -x射线管组件包含高-电压互感器组件；和 -X射线源、在患者体内成像的解剖对象和X射线图像接收器之间的几何关系在设计中预先设定，并且在预期使用期间不能由操作者任意改变。

IEC 60601-2-63:2012+A1:2017+A2:2021 applies to the basic safety and essential performance of dental extra-oral X-ray equipment, hereafter also called ME equipment. The scope includes ME systems containing such ME equipment. 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 extra-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 extra-oral x-ray equipment. Components and their functions are addressed as far as necessary. The scope of this standard is restricted to X-ray equipment where:
- the x-ray tube assembly contains the high-voltage transformer assembly; and
- the geometrical relations between the X-ray source, the anatomical object being imaged in the patient, and the X-ray image receptor, are preset in the design and cannot be arbitrarily altered by the operator during intended use.