标准摘要
[中文适用范围]： IEC 60601-1-3:2008+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图像用于医疗程序的诊断、规划或指导。本并列标准的目的是制定 X 射线设备中 X 射线防护的一般要求，以便将患者、操作员、工作人员和公众的辐射保持在合理可达到的最低水平，而不损害放射程序的益处。特定标准可以针对本并列标准中规定的一般要求指定其适当的值和/或措施。应在风险管理过程中证明实施一般要求或引用特定标准的合理性。该并列标准仅考虑与 X 辐射相关的辐射防护方面。用于产生 X 辐射的电能的控制要求（这也是辐射防护的一个重要方面）包含在 IEC 60601-1 中，特别是有关设备的安全和基本性能的标准中。本文件取消并取代了 1994 年发布的 IEC 60601-1-3 第一版（取代了 1973 年发布的 IEC 60407）。它构成了技术修订。该版本已根据 IEC 60601-1(2005) 进行了重组和调整，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。针对特定设备的特定要求已被删除，并将包含在特定标准中。有关变更的说明，请参阅附件 C 中的映射。该合并版本由第二版 (2008 年)、修订案 1 (2013 年) 和修订案 2 (2021 年) 组成。因此，除了本出版物之外，无需订购修订。 [外文原描述]： 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.
英文名称Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment