标准摘要
[中文适用范围]： 本国际标准适用于CT扫描仪的基本安全和基本性能，以下也称为ME设备。如果某个条款或子条款仅适用于ME设备或仅适用于ME系统，则该条款或子条款的标题和内容会说明。如果没有说明，则该条款或子条款适用于ME设备和ME系统。本文件的范围仅限于用于头部和身体的CT扫描仪，其特征是X射线源和成像探测器在一个共同的保护罩内，形状为环形。它包括用于CT扫描仪的X射线发生器的安全要求，包括那些高压发生器与X射线管组件集成在一起的。本国际标准的范围不包括放射治疗模拟器和通过非X射线管源创建图像的系统。 本特定标准的目的是为201.3.201中定义的CT扫描仪建立特定的基本安全和基本性能要求，以确保安全，并指定用于证明符合这些要求的方法。 [外文原描述]： IEC 60601-2-44:2009+A1:2012 applies to the basic safety and essential performance of CT scanners. The scope of IEC 60601-2-44:2009 is limited to CT scanners intended to be used for both head and body characterised by an enclosure of the X-ray source(s) and imaging detector(s) in a common protective cover in the shape of a toroid. It includes safety requirements for the X-ray generators used in CT scanners, including those where high-voltage generators are integrated with an X-ray tube assembly. This third edition cancels and replaces the second edition published in 2001 and its Amendment 1 (2002). This edition constitutes a technical revision primarily related to radiation protection and control. The contents of the corrigendum of May 2010 have been included in this copy. This consolidated version consists of the third edition (2009) and its amendment 1 (2012). Therefore, there is no need to order the amendment in addition to this publication.
英文名称Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography