电声学 测听设备 第7部分：听觉诱发电位测量仪器

[中文适用范围]： IEC 60645-7:2025 RLV 包含官方的 IEC 国际标准及其红线版本。红线版本仅提供英文版，便于用户快速、直观地比较该标准与前一版之间的所有修改内容。IEC 60645-7:2025 适用于设计用于测量由短时声学或振动刺激从内耳、听神经和脑干引发的听觉诱发电位的仪器。本文件规定了制造商应明确的特性，明确了两种仪器（筛查型和诊断/临床型）的性能要求，并规定了这两种类型仪器应具备的功能。此外，本文件还规定了描述用于听觉诱发电位设备和其他设备（如耳声发射仪器）的短时听觉诱发电位参考和测试信号的物理特性（以电信号波形形式）的方法，以及测量这些信号的方法。本文件的目的在于确保在符合本文件的不同仪器上，于可比的测试条件下进行的测量结果具有一致性。本文件无意限制新功能的开发或整合，也不应妨碍创新方法的应用。使用电刺激进行诱发电响应测量的内容超出了本文件的适用范围。 [外文原描述]： IEC 60645-7:2025 RLV contains both the official IEC International Standard and its Redline version. The Redline version is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its previous edition. IEC 60645-7:2025 applies to instruments designed for the measurement of auditory evoked potentials from the inner ear, the auditory nerve, and the brainstem, evoked by either acoustic or vibratory stimuli of short duration. This document defines the characteristics to be specified by the manufacturer, specifies performance requirements for two types of instruments (screening and diagnostic/clinical), and specifies the functions to be provided on these types. It also specifies a means of describing the physical characteristics, in terms of electrical waveforms, of audiometric reference and test signals of short duration used with auditory evoked potential equipment and other equipment (e.g. otoacoustic emission instruments), and methods for their measurement. The purpose of this document is to ensure that measurements made under comparable test conditions with different instruments complying with this document will be consistent. This document is not intended to restrict development or incorporation of new features, nor to discourage innovative approaches. Evoked response measurement using the application of electric stimuli to a subject is beyond the scope of this document.