ISO 5366:2016规定了成人和儿科气管造口管和接头的要求。此类导管主要用于需要麻醉、人工通气或其他呼吸支持的患者。 ISO 5366:2016也适用于具有共同属性的专用气管切开术管，例如，在机器端没有用于自主呼吸患者的连接器的管，以及具有加固壁或金属管或带肩部的管、锥形管、用于吸痰、监测或输送药物或其他气体的管。 气管造口管的易燃性是一种公认的危险（例如，当在富含氧化剂的环境中与易燃麻醉剂一起使用电外科装置或激光时），由适当的临床管理解决，不在本国际标准的范围内。 注ISO/TR 11991给出了避免气道火灾的指南。

ISO 5366:2016 specifies requirements for adult and paediatric tracheostomy tubes and connectors. Such tubes are primarily designed for patients who require anaesthesia, artificial ventilation or other respiratory support. ISO 5366:2016 is also applicable to specialized tracheostomy tubes that share common attributes, for example, those without a connector at the machine end intended for spontaneously breathing patients and those with reinforced walls or tubes made of metal or tubes with shoulders, tapering tubes, tubes with provision for suctioning or monitoring or delivery of drugs or other gases. Flammability of tracheostomy tubes is a well recognized hazard (for example, when electrosurgical units or lasers are used with flammable anaesthetic agents in oxidant-enriched atmospheres) that is addressed by appropriate clinical management and is outside the scope of this International Standard. NOTE ISO/TR 11991 gives guidance on avoidance of airway fires.