超声诊断设备声输出相关标准解读

Interpretation of Standards Related to Acoustic Output of Ultrasonic Diagnostic Equipment

医用超声诊断设备是医学上常用的计量设备之一,国家要求对超声诊断设备进行强制计量检定,但是在日常计量检定工作中,会遇到所依据的计量检定规程与国家标准不统一,或者不同超声诊断设备的检定规程所规定的超声源声输出参数各不相同的问题。本文将通过对超声诊断和监护设备专用安全要求相关标准的研究,解读声输出、声输出允许水平、声输出指数相关规定,梳理相关规定的演变,凸显最新研究成果,从而为制定或修订超声诊断设备相关规程、规范中声输出参数的确定,为超声诊断设备声输出参数的检定校准提供依据。

Medical ultrasound diagnostic equipment is one of the commonly used metrological equipment in medicine.The country requires mandatory metrological verification of ultrasound diagnostic equipment.However,in daily metrological verification work,there may be problems with inconsistent metrological verification regulations and national standards,or different ultrasound source output parameters specified in the verification regulations of different ultrasound diagnostic equipment.This article will study the relevant standards for the special safety requirements of ultrasound diagnostic and monitoring equipment,interpret the regulations on sound output,allowable level of sound output,and sound output index,sort out the evolution of relevant regulations,highlight the latest research results,and provide theoretical basis for the determination of sound output parameters in the formulation or revision of relevant regulations and specifications for ultrasound diagnostic equipment,and for the verification and calibration of sound output parameters ofultrasound diagnostic equipment.