核医疗设备.常规试验.第3部分:正电子放射断层摄影

[中文适用范围]： IEC 61948 的这一部分描述了正电子发射断层扫描仪 (PET) 的测试方法。作为质量控制的一部分，本文件定义了由正电子发射断层扫描仪用户执行的常规测试，以维持正确的操作条件。将这些常规测试的结果与验收测试期间或之后确定的参考数据进行比较。 IEC 61675-1:2013 中描述了验收测试所用的方法。此外，如今正电子发射断层扫描通常包括用于计算机断层扫描 (CT) 的 X 射线设备。对于本文件，PET/CT 混合设备被认为是最先进的，不包括 X 射线组件的专用正电子发射断层扫描仪仅是特殊情况。 IEC 61223-2-6 中描述了仅针对 PET/CT 的 CT 组件的质量控制测试。 CT 扫描仪还需根据 IEC 60601-1 以及适用的附属标准和特定标准进行型式测试。 [外文原描述]： IEC TR 61948-3:2018(E) describes test methods for Positron Emission Tomographs (PET). As part of quality control, this document is defining routine tests to be performed by the user of Positron Emission Tomographs to maintain proper operation conditions. The results of these routine tests are compared to the reference data determined during or after acceptance test. Methods used for acceptance tests are described in IEC 61675-1:2013. In addition, today a Positron Emission Tomograph often includes X-Ray equipment for Computed Tomography (CT). For this document, PET/CT hybrid devices are considered to be state of the art, dedicated Positron Emission Tomographs not including the X-ray component being special cases only. quality control tests specific to only the CT component of the PET/CT are described in IEC 61223-2-6. The CT scanner also is subject to a type test according to IEC 60601-1 and applicable collateral and particular standards. This second edition cancels and replaces the first edition published in 2005. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) a clause to check routine performance tests has been added, b) a test to check the accuracy of co-registration of PET and CT images has been added, c) a test to check image quality has been added, d) the test to check pixel size has been removed.