1.1范围:本国际标准适用于医用电气设备和医用电气系统（以下简称医用电气设备和医用电气系统）的基本安全和基本性能。本附带标准适用于X射线设备和此类设备的子组件，其中人类患者的放射图像用于诊断、规划或指导医疗程序。1.2目的:本附属标准的目的是规定除通用标准外的一般要求，并作为特定标准的基础。本附带标准的目的是制定X射线防护的一般要求- X射线设备中的辐射，以便将对人类患者、操作员、员工和公众的辐射保持在合理可行的最低水平，而不损害放射程序的效益。特殊标准可针对本附属标准中规定的一般要求规定其适当的数值和/或措施。一般要求的实施或特定标准的引用应在风险管理过程中得到证明。本附带标准仅考虑与X射线有关的辐射防护方面。用于产生X射线的电能控制要求- 辐射也是辐射防护的一个重要方面，包括在IEC 60601-1中，尤其是有关设备安全和基本性能的标准中。

1.1 Scope:This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.This collateral standard applies to X-RAY EQUIPMENT and to subassemblies of such equipment, where RADIOLOGICAL IMAGES of a human PATIENT are used for diagnosis, planning or guidance of medical procedures.1.2 Object:The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards.The object of this collateral standard is to establish general requirements for protection against X-RADIATION in X-RAY EQUIPMENT, in order that the IRRADIATION of the human PATIENT, the OPERATOR, staff and members of the public can be kept as low as reasonably achievable, without jeopardizing the benefit of the RADIOLOGICAL procedure. Particular standards may specify their appropriate values and/or measures for general requirements specified in this collateral standard. The implementation of the general requirements or the reference to the particular standard instead, shall be justified in the RISK MANAGEMENT process.This collateral standard considers RADIATION PROTECTION aspects related to X-RADIATION only.Requirements for the control of the electrical energy used to generate X-RADIATION, which is also an important aspect of RADIATION PROTECTION, are included in IEC 60601-1 and in particular standards for the safety and ESSENTIAL PERFORMANCE of the EQUIPMENT concerned.