超声波.脉冲回波扫描仪.验证成像系统基本性能稳定性的简单定期试验方法

[中文适用范围]： 本文件作为技术规范，规定了使用反射模式（脉冲回波）成像对具有线性阵列、曲线线性阵列、单元素、环形阵列、相控阵列、矩阵线性阵列换能器和二维阵列的诊断医学超声系统质量进行定期测试的要求和方法。包括图像测量和解释工作站。 注：通常，“定期测试”被称为“质量控制（QC）”或质量保证（QA）。 本文件代表了一组最低限度的测试，适用于医学超声系统的频繁用户、其组织中的质量控制专业人员或从其他质量控制和/或服务提供商组织雇用的专业人员。系统制造和维修公司可能会采用其他或额外的测试。测试分为三个级别，最简单和最具成本效益的测试最频繁执行，类似于其他标准。更完整的验收测试和在特定重要或关注时进行的评估测试在IEC 61391-1、IEC 61391-2和IEC TS 62791中规定。这些更完整的测试被归类为性能评估，而不是质量控制或频繁的定期测试。 本文件还定义了术语，并规定了测量（用于质量维护或质量控制）实时超声B模式扫描仪的最大相对穿透深度的方法，尽管这种穿透测量被列为较少应用。 本文件包括适用于医学超声系统频繁用户、其组织中的质量保证专业人员或从其他质量控制和/或服务提供商组织雇用的专业人员的最低限度测试集。程序适用于广泛的更常见的诊断超声系统，目前工作频率从1 MHz到40 MHz，尽管可用的模型仅满足1 MHz到23 MHz的规格。 测试分为三个级别，最简单和最具成本效益的测试最频繁执行： 级别1包括五个快速测试/观察，通常由系统操作人员每天到每月执行。 级别2包括一个对所有系统必要的测试，除了级别1的测试外，两个级别1测试更严格地执行，两个测试用于特殊情况或设备，一个只是可选的，因为它高度发展。级别2测试由具有有意义的质量保证培训的人员每年执行。 级别3将两个特殊情况测试扩展到所有系统，增加一个可选测试，并包括对QA计划的定期审查。 本文件仅推荐对某些类别的位置编码进行频繁的距离测量精度测试，这些编码目前已知不具有高度稳定性和无偏差。本文件推荐在所有维度上进行QA作为此类系统的第一个测试。 测试方法适用于工作在1 MHz至23 MHz频率范围内的换能器。这些扫描仪使用的换能器类型包括： a) 电子相控阵列， b) 线性阵列， c) 曲线凸阵列， d) 机械探头换能器， e) 在2D成像模式下操作的二维阵列， f) 在3D成像模式下操作的换能器，用于有限数量的重建2D图像集，以及 g) 基于上述类型组合的三维扫描探头换能器。 不易通过简单图像均匀性程序进行换能器元件测试的换能器（例如相控阵列和二维阵列换能器）仅通过最大相对穿透深度进行部分测试。鼓励系统制造商提供换能器元件的脉冲模式，以允许对单个元件或足够小的元件组进行测试，使用户能够检测到显著的元件故障或访问另一个已实现并解释的元件测试程序。专用多普勒系统不在此范围内，因为测试它们需要专用设备。这种测试设备可以特定于多普勒系统的预期应用。 所有考虑的扫描仪都包括基本的脉冲回波技术。通过推荐的脉冲回波测试检测到的故障也会影响其他模式的操作，如彩色血流、谐波、弹性和复合成像。测试方法适用于工作在1 MHz至17 MHz频率范围内的换能器，如果允许穿透深度是相对的而不是绝对的，并且模型稳定性得到验证，则可以适用于高达40 MHz。图像均匀性QC适用于工作在1 MHz至40 MHz频率范围内的换能器，因为对模型的要求不严格。 注：鼓励模型制造商扩展模型的频率范围，以便能够对工作在基本和谐波频率高于17 MHz的系统进行相对穿透深度测试。 所有在此考虑的扫描仪测试评估基本的脉冲回波技术，并可能检测其他模式中的大多数故障。专用多普勒系统或其他用于检测血液运动的系统不在此范围内，因为测试它们需要专用设备。这种测试设备可以特定于多普勒系统的预期应用。 本文件包括术语的定义，并规定了测量实时超声B模式扫描仪的最大相对穿透深度的方法，尽管这种穿透测量被列为较少应用。 [外文原描述]： IEC TS 62736:2023 RLV contains both the official IEC International Standard and its Redline version. The Redline version is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its previous edition. IEC TS 62736:2023 specifies requirements and methods for periodic testing of the quality of diagnostic medical ultrasound systems using reflection-mode (pulse-echo) imaging. Image measurement and interpretation workstations are included. This document includes minimum sets of such tests intended for frequent users of medical ultrasound systems, for quality assurance professionals in their organizations, or those hired from other quality-control and/or service-provider organizations. The procedures are for a wide range of more common diagnostic ultrasound systems, currently operating from 1 MHz to 40 MHz, although available phantoms meet the specifications only from 1 MHz to 23 MHz. The tests are defined in three levels, with the simplest and most cost-effective performed most frequently: - Level 1 comprises five quick tests/observations to be performed daily to monthly by those normally operating the systems. - Level 2 includes one necessary test for all systems in addition to those of Level 1, two Level 1 tests performed more rigorously, two tests that are for special situations or equipment, and one that is just optional, included because it is highly developed. Level 2 tests are performed annually by those with meaningful quality assurance training. - Level 3 extends the two special situations tests to all systems, adds one optional test and includes a periodic review of the QA programme. Frequent distance-measurement accuracy tests are recommended in this document only for certain classes of position encoding that are not now known to be highly stable and without bias. QA in all dimensions is recommended in this document as the first test for such systems. The test methodology is applicable for transducers operating in the 1 MHz to 23 MHz frequency range. The types of transducers used with these scanners include a) electronic phased arrays, b) linear arrays, c) convex arrays, d) mechanical transducers, e) two-dimensional arrays operated in a 2D imaging mode, f) transducers operating in 3D imaging mode for a limited number of sets of reconstructed 2D images, and g) three-dimensional scanning transducers based on a combination of the above types. All tests on scanners considered here evaluate basic pulse-echo techniques and might detect most failures in other modes. Dedicated Doppler systems, or other systems for detection of blood motion, are excluded from this scope as specialized equipment is required to test them. Such test equipment can be specific to the intended application of the Doppler system. This document includes definition of terms and specifies methods for measuring the maximum relative depth of penetration of real-time ultrasound B MODE scanners, though this penetration measure is listed as less frequently applied. IEC TS 62736:2023 cancels and replaces the first edition published in 2016. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) expansion of the applicable types of transducers and the frequency range of application; b) extension of test protocols and image assessments, including for very-low-echo spheres; c) revision of phantom designs and their acoustic properties, consistent with the second edition of IEC TS 62791; d) inclusion of luminance tests for system-image display consistency at scanner and remote monitors; e) addition of special considerations for 3D-imaging transducers (Annex D) and workbook examples (Annex E).