本文件规定了用于向患者输送指定氧气浓度的引气装置的最低性能和安全要求。它提供了一种测试方法，用于检查由引气装置产生的空气/氧气混合物中氧气浓度的准确性。夹带空气装置可以固定以提供单个氧气浓度，也可以调整以提供一系列氧气浓度输出。 本文件还规定了标记要求，并推荐了可选的颜色编码系统，以帮助用户识别指定的氧气浓度。 本文件不包括与其他标准中规定的医疗器械（例如，医疗器械）整合在一起的夹带空气的器械。 g、 紧急呼吸机、加湿器、雾化器）。

This document specifies minimum performance and safety requirements for air entrainment devices used for delivery of designated oxygen concentrations to patients. It provides a test method to check the accuracy of the oxygen concentration in the air/oxygen mixture generated by the air entrainment devices. Air entrainment devices can be fixed to deliver a single oxygen concentration or adjustable, to deliver a range of oxygen concentration outputs. This document also specifies marking requirements and recommends an optional system of colour coding to assist the user in identifying the designated oxygen concentration. This document does not cover air entrainment devices which are integral with medical devices specified in other standards (e.g. emergency lung ventilators, humidifiers, nebulizers).