Standardisation of the particular requirements for basic safety and essential performance of medical devices and their accessories that connect to or are inserted into the airways of patients, including those devices that provide the interface between the patient and atmosphere or gas from a supply device.

Examples include tracheal and tracheostomy tubes, supralaryngeal and oropharyngeal airways, laryngoscopes, connectors, breathing system tubing, respiratory therapy tubing, nebulizers, breathing filters, suction catheters, fire-activated oxygen shut off devices.