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现行 EN ISO 5361:2023
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Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2023, Corrected version 2023-11) 麻醉和呼吸设备气管导管和连接器
发布日期: 2023-02-01
实施日期: 2023-02-01
本文件对经口气管和鼻气管管以及气管管连接器、壁用金属或塑料加固的气管管、肩部气管管、锥形气管管、带有药物或其他气体抽吸、监测或输送装置的气管管的基本安全性和基本性能提出了具体要求,以及为专门应用而设计的许多其他类型的气管管。 气管支气管(包括支气管内)管(见ISO 16628)、气管造口管(见ISO5366)和喉上气道(见ISO 11712)不在本文件范围内。 用于易燃麻醉气体或药剂、激光或电外科设备的气管导管不在本文件的范围内。 注1附录A.2中包含本条款的指导或基本原理。 注2 ISO 11990-1、ISO 11990-2和ISO 14408涉及气道激光手术。
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.
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归口单位: CEN/TC 215
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