IEC 60601-2-63:2012+A1:2017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射线管组件包含高压变压器组件；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。该合并版本由第一版（2012年）及其修正案1（2017年）组成。因此，除本出版物外，无需下令修订。

IEC 60601-2-63:2012+A1:2017 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. This consolidated version consists of the first edition (2012) and its amendment 1 (2017). Therefore, no need to order amendment in addition to this publication.