医疗电气设备. 第2-36部分: 体外引发碎石设备的基本安全和基本性能的详细要求

[中文适用范围]： 替换：本特定标准适用于 201.3.206 中定义的体外诱导碎石设备的基本安全和基本性能，包括用于治疗性体外诱导聚焦压力脉冲@的其他医疗应用的设备，以下简称 ME 设备。该特定标准的适用性仅限于直接参与碎石治疗@的组件，例如@但不限于@压力脉冲发生器@患者支持装置@及其与成像和监测设备的相互作用。其他设备@例如患者治疗计划计算机@X射线和超声设备@不包括在本标准@中，因为它们是按照其他适用的IEC标准进行处理的。本特殊标准不适用于： 旨在用于物理治疗的超声波物理治疗设备； ?C 用于高强度治疗性超声 (HITU) 的超声设备和附录 AA 中描述的其他治疗设备； [外文原描述]： IEC 60601-2-36:2014 applies to basic safety and essential performance of equipment for extracorporeally induced lithotripsy including equipment for other medical applications of therapeutic extracorporeally induced focused pressure pulses. The applicability of this particular standard is limited to components directly involved in the lithotripsy treatment, such as, but not limited to, the generator of the pressure pulse, patient support device, and their interactions with imaging and monitoring devices. Other devices, such as patient treatment planning computers, X-ray and ultrasonic devices, are excluded from this standard, because they are treated in other applicable IEC standards. This particular standard does not apply to ultrasound physiotherapy equipment intended to be used for physiotherapy; abd to ultrasound equipment intended to be used for high intensity therapeutic ultrasound (HITU) and other therapy equipment as described in Annex AA. This second edition cancels and replaces the first edition of IEC 60601-2-36 published in 1997. This edition constitutes a technical revision to align structurally with IEC 60601-1:2005 and its Amendment1:2012.