ISO 5366:2016规定了成人和儿科气管造口管和连接器的要求。这种管主要设计用于需要麻醉，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造口管，例如，在机器端没有连接器的那些，用于自发呼吸的患者，以及具有加强的墙壁或带金属或管的管子的肩部，锥形管，管子用于吸引或监测或输送药物或其他气体。 气管造口管的易燃性是一个公认的危险（例如，当电外科手术单元或激光与富含氧化剂的气氛中的易燃麻醉剂一起使用时），这通过适当的临床管理来解决，并且超出了本国际标准的范围。 注意ISO/TR 11991提供了避免气道火灾的指导

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.