IEC 61157:2007/AMD1:2013
Amendment 1 - Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
发布时间:2013-01-28 实施时间:


医疗诊断超声设备是一种常见的医疗设备,用于诊断和治疗各种疾病。超声设备通过发射高频声波来产生图像,这些声波可以穿透人体组织并被不同类型的组织反射。超声设备的声学输出是指设备发射的声波的强度和频率。声学输出的准确性和可比性对于超声设备的正常运行和诊断结果的准确性至关重要。

IEC 61157:2007/AMD1:2013标准规定了超声设备声学输出的测量方法和报告要求。该标准要求使用标准化的测量方法来测量超声设备的声学输出。测量方法包括使用标准化的声学测量设备和测量程序。测量结果应该在标准化的报告格式中报告,以确保结果的可比性。

IEC 61157:2007/AMD1:2013标准还规定了超声设备声学输出报告的内容和格式。报告应包括设备的型号和序列号、测量日期和时间、测量位置、测量参数、测量结果和不确定度等信息。报告应以标准化的格式呈现,以确保报告的可读性和可比性。

IEC 61157:2007/AMD1:2013标准的实施可以确保超声设备声学输出的准确性和可比性。这有助于确保超声设备的正常运行和诊断结果的准确性。此外,该标准还可以促进超声设备制造商之间的竞争和合作,以提高超声设备的质量和性能。

相关标准
- IEC 60601-2-37:2018 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- IEC 62359:2013 Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
- IEC 61689:2013 Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
- IEC 60601-2-37:2018 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- IEC 62359:2013 Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields