IEC 60601-1-3:20 08+A1:2013+A2:2021适用于X射线设备和此类设备的组件，其中人类患者的放射学图像用于医疗程序的诊断、规划或指导。本附带标准的目的是建立X射线设备中X射线防护的一般要求，以便在不损害放射程序的益处的情况下，将人类患者、操作者、工作人员和公众的辐射保持在合理可达到的最低水平。特定标准可以针对本抵押品标准中规定的一般要求规定其适当的值和/或度量。在风险管理过程中，应证明实施一般要求或参考特定标准是合理的。该附带标准仅考虑与X射线相关的辐射防护方面。用于产生X射线的电能的控制要求也是辐射防护的一个重要方面，包含在IEC 60601-1中，特别是相关设备的安全和基本性能标准中。本文件取消并取代1994年发布的第一版IEC 60601-1-3（取代1973年发布的IEC 60407）。它构成技术修订。该版本经过重组并与IEC 60601-1（2005）保持一致，重点关注适用于所有诊断X射线设备的辐射防护的一般要求。特定设备的特定要求已被删除，并将在特定标准中涵盖。有关变更的说明，请参见附录C中的映射。该合并版本由第二版（2008年）、修正案1（2013年）和修正案2（2021年）组成。因此，除了本出版物之外，没有必要下令进行修订。

IEC 60601-1-3:2008+A1:2013+A2:2021 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. 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. This document cancels and replaces the first edition of IEC 60601-1-3, published in 1994 (which replaced IEC 60407 issued in 1973). It constitutes a technical revision. This edition has been restructured and aligned to IEC 60601-1(2005) and focussed on general requirements for RADIATION PROTECTION that apply to all diagnostic X-RAY EQUIPMENT. Requirements particular to specific equipment have been removed and will be covered in particular standards. For a description of the changes, see the mapping in Annex C. This consolidated version consists of the second edition (2008), its amendment 1 (2013) and its amendment 2 (2021). Therefore, no need to order amendments in addition to this publication.