YY/T 0337-2025 Pending Industry standards-Medicine

YY/T 0337-2025 Anaesthetic and respiratory equipment—Tracheal tubes and connectors

YY/T 0337-2025 Anaesthetic and respiratory equipment—Tracheal tubes and connectors

Publish Date: 2025-09-15 Implement Date: 2026-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0337-2025

Standard Type: Industry standards

Standard Status: Pending

is_force_gb: no

CCS Name: Surgical room equipment

ICS Name: Anesthesia, respiration, and resuscitation equipment

Publish Date: 2025-09-15

Implement Date: 2026-10-01

Publisher: 国家药品监督管理局

Technical Committee: 全国麻醉和呼吸设备标准化技术委员会(SAC/TC 116)

Pages: 52 pages

Scope

本文件规定了经口、经鼻气管插管和气管插管接头，管壁用金属或塑料作为加强筋的气管插管，有肩部的气管插管、锥形气管插管，提供具有抽吸、监测或输送药物或其他气体的气管插管，以及为特殊用途而设计的多种其他类型的专用气管插管的基本安全和基本性能。
本文件适用于上述气管插管。
本文件不适用于气管支气管导管（包括支气管内管）（见YY/T 0490）、气管切开插管和接头（见YY/T 0338）和上喉部通气道（见YY/T 0985）。
本文件不适用于与易燃麻醉气体或药剂、激光或外科电气设备一起使用的气管插管。
注1：附录A中A.2给出了有本章相关的指南或基本原理。
注2：涉及气道激光手术的ISO 11990-1、ISO 11990-2和ISO 14408。

Development Information

Drafting Units:

上海市医疗器械检验研究院、山东省医疗器械和药品包装检验研究院、柯惠医疗器材国际贸易(上海)有限公司、广州维力医疗器械股份有限公司、宁波华坤医疗器械有限公司、亚都医疗科技(河南)有限公司

Drafting Persons:

付强、王秀秀、莫艳君、刘晶、徐结兵、许慧、陈发慧、艾冲冲

Word Count: 76 Thousand words Pages: 52 pages

Replace the following standards

YY/T 0337.1-2002 Tracheal tubes Part 1:—Commonly-used tubes and connectors YY/T 0337.2-2002 Tracheal tubes—Part 2:Cole type tube YY 0337.2-2002 Tracheal tubes—Part 2:Cole type tube

Referenced Standards

GB/T 4999-2003 Anaesthetic and respiratory equipment—Vocabulary GB/T 42062-2022 Medical devices—Application of risk management to medical devices YY/T 0586-2005 Medical polymer products—Test methods of radiopacity YY/T 0586-2016 Medical polymer products-Test methods of radiopacity YY/T 0916.7-2024 Small-bore connectors for liquids and gases in healthcare applications—Part 7:Connectors for intravascular or hypodermic applications YY 1040.1-2003 Anaesthetic and respiratory equipment—Conical connectors—Part 1:Cones and sockets YY/T 1040.1-2015 Anaesthetic and respiratory equipment—Conical connectors—Part 1:Cones and sockets YY/T 1844-2022 Anaesthetic and respiratory equipment—General requirements for airways and related equipment ISO 18562(所有部分)

Adopt standards

ISO 5361:2023

Related Standards

GB 11246-1989 Abolished

GB 11246-1989 Specifications for continuous flow inhalational anaesthetic machines for use with humans

Publish Date: 1989-03-31

YY 0339-2002 Replaced

YY 0339-2002 Suction catheter for use in the respiratory tract

Publish Date: 2002-09-24

YY/T 0337.1-2002 Active

YY/T 0337.1-2002 Tracheal tubes Part 1:—Commonly-used tubes and connectors

Publish Date: 2002-09-24

YY/T 0337.2-2002 Active

YY/T 0337.2-2002 Tracheal tubes—Part 2:Cole type tube

Publish Date: 2002-09-24

YY/T 0338.1-2002 Replaced

YY/T 0338.1-2002 Tracheostomy tubes—Part 1:Tubes and connectors for adults

Publish Date: 2002-09-24

YY/T 0338.2-2002 Replaced

YY/T 0338.2-2002 Tracheostomy tubes—Part 2:Paediatric tracheostomy tubes

Publish Date: 2002-09-24