本文件规定了用于向患者输送指定浓度氧气的空气夹带装置的最低性能和安全要求。它提供了一种测试方法来检查由空气夹带装置产生的空气/氧气混合物中的氧气浓度的准确性。空气夹带装置可以是固定的以输送单个氧气浓度或可调节的以输送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。 本文件不涵盖与其他标准中规定的医疗器械集成的空气夹带装置（例如，紧急肺呼吸机、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).