高强度超声波治疗设备(HITU)的测量标准要求

[中文适用范围]： 本技术报告与用于医学治疗目的的超声场的测量和规范相关。碎石术和物理治疗被排除在外，因为这些应用已有国际标准。它规定： ?一致认为制定国际标准将有利于行业和/或患者的主题； ？应立即开始编写标准的主题； ？应立即开始编写技术规范的主题，以便在标准化之前获得实践经验并建立共识； ？需要未来标准化但在开始编写标准或技术规范之前需要进一步研究的主题。本报告主要解决与高强度治疗超声 (HITU) [也称为高强度聚焦超声 (HIFU)] 场相关的测量标准的要求，这些场既是高强度的又是聚焦的，其主要作用机制是热力。然而，讨论、结论和任何由此产生的标准或技术规范的方面也可能与集中或高强度或主要机制不是热的治疗应用相关。我们对科学文献进行了审查，并报告了对发送给世界各地专家的调查问卷的答复。 [外文原描述]： IEC/TR 62649:2010(E) is relevant to the measurement and specification of ultrasound fields intended for medical therapeutic purposes. Lithotripsy and physiotherapy are excluded, since there are existing International Standards for these applications. IEC/TR 62649:2010 establishes: - topics where there is a consensus that the development of International Standards would benefit the industries and/or patients; - topics where the writing of standards should start immediately; - topics where the writing of technical specifications should start immediately in order to gain practical experience and establish consensus prior to standardisation; - topics which require future standardisation but where further research is required before initiating the writing of standards or technical specifications. IEC/TR 62649:2010 addresses primarily the requirements for measurement standards related to high intensity therapeutic ultrasound (HITU) [also known as high intensity focused ultrasound (HIFU)] fields which are both high intensity and focused and where the main mechanism for action is thermal. However, aspects of the discussion, conclusions and any resulting standards or technical specifications may also be relevant to therapeutic applications which are either focused or high intensity or where the main mechanism is not thermal. Scientific literature has been reviewed and responses to a questionnaire which was sent to experts around the world are reported.