医疗电气设备.第2-37部分:超声波医疗诊断和监测设备的基本安全和基本性能用特殊要求

[中文适用范围]： 本国际标准适用于201.3.217定义的超声诊断设备的基本安全和基本性能，以下简称ME设备。如果某条款或子条款专门旨在仅适用于 ME 设备或仅适用于 ME 系统，则该条款或子条款的标题和内容将如此说明。如果情况并非如此，则该条款或子条款适用于相关的 ME 设备和 ME 系统。除本标准 7.2.13 和 8.4.1 外，本标准范围内 ME 设备或 ME 系统的预期生理功能固有的危险不属于本标准的具体要求。注：另见本标准第 4.2 条。该特定标准不涵盖超声治疗设备。涵盖用于通过超声波结合其他医疗程序对身体结构进行成像或诊断的设备。 [外文原描述]： Applies to the basic safety and essential performance of ultrasonic diagnostic equipment. The approach and philosophy used in drafting this particular standard for safety of ultrasonic diagnostic equipment are consistent with those in standards of the IEC 60601 2 xx series that apply to other diagnostic modalities, such as X-ray equipment and magnetic resonance systems. In each case, the safety standard is intended to require increasing sophistication of output display indicators and/or controls with increasing energy levels in the interrogating field of diagnosis. Thus, for all such diagnostic modalities, it is the responsibility of the operator to understand the risk of the output of the ultrasonic diagnostic equipment, and to act appropriately in order to obtain the needed diagnostic information with the minimum risk to the patient. This second edition cancels and replaces the first edition published in 2001 and its Amendment 1 (2004) and Amendment 2 (2005). This edition combines the previous edition and its amendments into a form compatible with the parent IEC 60601-1:2005.