医疗诊断超声波设备声输出的报告用标准方法

[中文适用范围]： 本国际标准适用于医用超声诊断设备。 – 它提供了一组描述声场的可追踪声学参数。 – 它定义了报告声输出信息的标准方法和格式。 – 它还描述了建议用于产生低声输出水平的设备的简化数据集。注：本标准格式中列出的信息可用于 a) 生物效应研究的暴露计划； b) 使用与本标准中报告的类似的暴露条件进行的前瞻性流行病学研究的暴露数据。在缺乏回顾性流行病学研究的实际暴露数据的情况下，也可以在使用此标准格式中列出的信息时提出警告。 [外文原描述]： IEC 61157:2007 specifies a standard means and format for the reporting of the acoustic output of medical diagnostic ultrasonic equipment. The numerical values for reporting purposes represent the average values for the maximum output conditions for a given discrete- or combined-operating mode and are derived from measurements made in water. Intensity parameters are specified in this standard, but these are regarded as derived quantities that are meaningful only under certain assumptions related to the ultrasonic field being measured. This International Standard is applicable to medical diagnostic ultrasonic equipment. It provides a set of traceable acoustic parameters describing the acoustic fields. It defines a standard means and format for the reporting of the acoustic output information. It also describes a reduced dataset recommended for equipment generating low acoustic output levels. This second edition cancels and replaces the first edition published in 1992. This edition constitutes a minor revision. The changes with respect to the previous edition are listed hereafter: - maintenance on this standard and the referenced standards IEC 61161 and IEC 62127-1; - and a clause on compliance has been added. The contents of the corrigendum of August 2008 have been included in this copy. The French version of this standard has not been voted upon.