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现行 IEC TS 62736:2023
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Ultrasonics - Pulse-echo scanners - Simple methods for periodic testing to verify stability of an imaging system's elementary performance 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
发布日期: 2023-01-13
IEC TS 62736:2023作为IEC TS 62736:2023 RLV提供,其中包含国际标准及其红线版本,显示了与上一版本相比技术内容的所有变化。IEC TS 62736:2023规定了定期测试的要求和方法使用反射模式(脉冲回波)成像的诊断医学超声系统的质量。包括图像测量和解释工作站。本文件包括用于医疗超声系统的频繁用户、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人员的此类测试的最小集合。这些程序适用于各种更常见的超声诊断系统,目前工作频率为1 MHz至40 MHz,尽管可用的体模仅满足1 MHz至23 MHz的规格。这些测试分为三个级别,其中最简单且最具成本效益的测试最常执行: -第1级包括由系统正常操作人员每日至每月进行的五次快速测试/观察。 -2级包括除1级之外的所有系统的一项必要测试、两项更严格执行的1级测试、两项针对特殊情况或设备的测试以及一项只是可选的测试,因为它是高度开发的。2级测试每年由受过有意义的质量保证培训的人员进行。 -第3级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。 本文档中仅建议对某些类别的位置编码进行频繁的距离测量精度测试,这些类别现在还不知道是高度稳定和无偏差的。本文档建议将所有维度的QA作为此类系统的首次测试。 该测试方法适用于工作在1 MHz至23 MHz频率范围内的传感器。与这些扫描仪一起使用的传感器类型包括 a)电子相控阵, b)线性阵列, c)凸阵列, d)机械换能器, e)以2D成像模式操作的二维阵列, f)在3D成像模式下操作以用于有限数量的重建2D图像的换能器,以及 g)基于上述类型的组合的三维扫描换能器。 这里考虑的扫描仪上的所有测试都评估了基本的脉冲回波技术,并可能检测到其他模式下的大多数故障。专用多普勒系统或用于检测血液运动的其他系统被排除在此范围之外,因为需要专门的设备来测试它们。这种测试设备可以特定于多普勒系统的预期应用。本文件包括术语定义,并规定了测量实时超声B型扫描仪最大相对穿透深度的方法,尽管该穿透测量被列为不太常用。 IEC TS 62736:2023取消并取代了2016年发布的第一版。本版构成技术修订版。 与上一版相比,此版本包括以下重大技术变更: a)适用的换能器类型和应用的频率范围的扩展; b)扩展测试方案和图像评估,包括用于极低回波球体; c)根据IEC TS 62791第二版修订体模设计及其声学特性;d)包括用于扫描仪和远程监视器处的系统图像显示一致性的亮度测试; e)添加3D成像传感器的特殊考虑因素(附录D)和工作手册示例(附录E)。
IEC TS 62736:2023 is available as IEC TS 62736:2023 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the 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).
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归口单位: TC 87
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