IEC 60601-1-3:2008 医疗电气设备 - 第1-3部分:基本安全和基本性能的一般要求 - 附带标准:诊断X射线设备中的辐射防护

标准编号：IEC 60601-1-3:2008

中文名称：医疗电气设备 - 第1-3部分:基本安全和基本性能的一般要求 - 附带标准:诊断X射线设备中的辐射防护

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

发布日期：2008-01-22

标准范围

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。本附带标准的目的是制定X射线设备中X射线防护的一般要求，以便在不损害放射程序效益的情况下，将人类患者、操作员、员工和公众的辐射保持在合理可行的最低水平。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。IEC 60601-1，尤其是相关设备的安全和基本性能标准，包含了产生X射线的电能控制要求，这也是辐射防护的一个重要方面。本文件取消并取代IEC 60601第一版-1-3，1994年出版（取代1973年发布的IEC 407）。这是一项技术性修订。本版本已根据IEC 60601-1（2005）进行了重组和调整，并侧重于适用于所有诊断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，并将包含在特定标准中。有关更改的描述，请参见附录C中的映射。

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. 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 407 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.

标准预览图