麻醉和呼吸设备 气管导管和连接件

[中文适用范围]： 本文件规定了经口气管插管和鼻气管插管以及气管插管连接器、具有金属或塑料加固壁的气管插管、带肩部的气管插管、锥形气管插管、带有用于固定装置的气管插管的基本安全和基本性能的具体要求。 药物或其他气体的抽吸、监测或输送，以及专为特殊应用而设计的许多其他类型的气管导管。 气管支气管（包括支气管内）导管（参见 ISO 16628）、气管造口导管（参见 ISO 5366）和喉上气道（参见 ISO 11712）不包括在本文件的范围内。 用于易燃麻醉气体或麻醉剂、激光或电外科设备的气管导管不在本文件的范围内。 注 1：附件 A.2 中包含本条款的指导或理由。 注 2：ISO 11990-1、ISO 11990-2 和 ISO 14408 涉及气道激光手术。 [外文原描述]： This document provides specific requirements for the basic safety and essential performance for oro - tracheal and naso-tracheal tubes and tracheal tube connectors , tracheal tubes with walls reinforced with metal or plastic, tracheal tubes with shoulders , tapered tracheal tubes , tracheal tubes with means for suctioning, monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for specialized applications. Tracheobronchial (including endobronchial) tubes (see ISO 16628), tracheostomy tubes (see ISO 5366), and supralaryngeal airways (see ISO 11712) are excluded from the scope of this document. Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical equipment are outside the scope of this document. NOTE 1 There is guidance or rationale for this clause contained in Annex A.2. NOTE 2 ISO 11990-1, ISO 11990-2, and ISO 14408 deal with laser surgery of the airway.