ISO 11712:2023 PDF

This document provides the essential requirements for the design of supralaryngeal airways and connectors. These devices are intended to provide a distinct respiratory pathway to the top of the larynx to provide an unobstructed airway in patients during spontaneous, assisted or controlled ventilation. This document specifies the dimensions, basic properties and method of size designation of the available types of supralaryngeal airways. Airways devised for specialized applications are not specifically covered, although most may be classified by the sizing and dimensions (or other characteristics) required by this document. The following devices are outside the scope of this document: nasal and oropharyngeal airways, anesthetic masks, oro- and naso-tracheal tubes, cricothyrotomy devices, dental appliances, tracheal stents, tracheal tubes, ventilating laryngoscopes, CPAP devices, esophageal obturators, bougies and devices that require surgical placement. This document specifies dimensional disclosure so the operator will know which auxiliary devices, such as tracheal tubes and bronchoscopes will be size-compatible. Flammability of airways, for example if used with certain flammable anesthetic gases, electrosurgical units or lasers, is a well-recognized hazard that is outside the scope of this document. (See E.1.7).