ISO 11712:2023 麻醉和呼吸设备 上喉导气管和连通器

标准编号：ISO 11712:2023

中文名称：麻醉和呼吸设备 上喉导气管和连通器

英文名称：Anaesthetic and respiratory equipment — Supralaryngeal airways and connectors

发布日期：2023-11

标准范围

本文件提供了喉上气道和连接器设计的基本要求。这些装置旨在提供到喉顶部的独特呼吸路径，以在自发、辅助或控制通气期间为患者提供通畅的气道。本文件规定了可用类型的喉上气道的尺寸、基本特性和尺寸指定方法。为特殊应用设计的气道没有具体涵盖，尽管大多数气道可以根据本文件要求的尺寸和尺寸（或其他特征）进行分类。以下器械超出了本文件的范围:鼻和口咽气道、麻醉面罩、口和鼻气管导管、环甲切开术器械、牙科器械、气管支架、气管导管、通气喉镜、CPAP器械、食管闭塞器、探条和需要手术放置的器械。本文件规定了尺寸披露，以便操作者知道哪些辅助设备（如气管导管和支气管镜）尺寸兼容。气道的可燃性（例如，如果与某些易燃麻醉气体、电外科设备或激光一起使用）是公认的危害，超出了本文档的范围。（见E.1.7）。

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).

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