标准摘要
[中文适用范围]： 本国际标准适用于牙科口内X射线设备及其主要组件的基本安全和基本性能，以下也称为医疗设备。 本标准范围仅限于X射线管组件包含高压变压器组件的X射线设备。 牙科口外X射线设备不在本标准范围内。 注1：牙科口内X射线设备中的X射线发生器始终包含X射线单体组件。因此，在本特定标准中，X射线管组件的概念被X射线单体组件所取代。 注2：主要组件可以是例如X射线单体组件和电子X射线图像接收器。 注3：光激发荧光板及其读取器（硬件和软件）不在本特定标准范围内，因为它们在患者环境中没有电气应用部件，也不是医疗设备。 IEC 60601-2-63、IEC 60601-2-44、IEC 60601-2-54、IEC 60601-2-45或IEC 60601-2-43范围内的医疗设备和医疗系统不在本特定标准范围内。本国际标准的范围还包括放射治疗模拟器和用于骨或组织吸收密度测量的设备。也不适用于用于牙科放射检查的医疗设备。 在其特定范围内，本特定标准的条款取代并替换了IEC 60601-2-7《医用电气设备——诊断X射线发生器高压发生器的特殊安全要求》和IEC 60601-2-32《医用电气设备——X射线设备相关设备的特殊安全要求》。 注4：以前在IEC 60601-2-7和IEC 60601-2-32中规定的X射线发生器和相关设备的要求，已包括在IEC 60601-1:2005（第3版）或本特定标准中。因此，IEC 60601-2-7和IEC 60601-2-32不属于IEC 60601-1第3版方案中针对牙科口内X射线设备的部分。 本特定标准涵盖了所有关于集成X射线管组件的要求。因此，IEC 60601-2-28不适用于本国际标准范围内的医疗设备。 [外文原描述]： IEC 60601-2-65:2012+A1:2017 applies to the basic safety and essential performance of dental intra-oral X-ray equipment and its main components. The scope of this standard is restricted to X-ray equipment where the X-ray tube assembly contains the high-voltage transformer assembly. Dental extra-oral X-ray equipment is excluded from the scope of this standard. 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 intra-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 intra-oral X-ray equipment. Components and their functions are addressed as far as necessary. 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.
英文名称Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment