麻醉和呼吸设备 喉上气道和连接器

[中文适用范围]： 注：本条款的指导或原理见附件 A.2。1.1 本文件规定了喉上气道和连接器设计的基本要求。这些装置旨在为喉部顶部提供一条独特的呼吸路径，以便在患者自主、辅助或控制通气期间提供畅通的气道。1.2 本文件规定了现有喉上气道类型的尺寸、基本属性和尺寸指定方法。没有特别涵盖为特殊用途设计的气道，尽管大多数气道可以根据本文件要求的尺寸和尺寸（或其他特性）进行分类。1.3 以下设备不在本文件的讨论范围内：鼻腔和口咽气道、麻醉面罩、口鼻气管插管、环甲膜切开装置、牙科器具、气管支架、气管插管、通气喉镜、CPAP 设备、食管封堵器、探条和需要手术放置的设备。1.4 本文件规定了尺寸披露，以便操作员知道哪些辅助设备（如气管插管和支气管镜）的尺寸兼容。1.5 气道的可燃性（例如，如果与某些易燃麻醉气体、电外科装置或激光器一起使用）是一种公认的危险，不在本文件的讨论范围内。（见 E.1.7）。 [外文原描述]： 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).