YY/T 0893-2023 Active Industry standards-Medicine

YY/T 0893-2023 Gas mixers for medical use—Standalone gas mixers

Publish Date: 2023-03-14 Implement Date: 2024-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0893-2023

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Surgical room equipment

ICS Name: Anesthesia, respiration, and resuscitation equipment

Publish Date: 2023-03-14

Implement Date: 2024-05-01

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: 24 pages

Scope

本文件规定了预期用于将氧气与另一种医用气体混合的独立气体混合器的性能和安全要求。
本文件不适用于：
a) 每种气体流量独立控制的流量计组；
b) 混合氧气和周围空气的独立气体混合器；
c) 具有两个以上不同气体进气口的独立气体混合器；
d) 与氧气浓缩器相连的独立气体混合器。

Development Information

Drafting Units:

上海市医疗器械检验研究院、宁波戴维医疗器械股份有限公司、捷锐企业(上海)有限公司

Drafting Persons:

张春元、郭永兵、王永毅、付强、王伟、钱心依、史东卓

Word Count: 43 Thousand words Pages: 24 pages

Replace the following standards

YY/T 0893-2013 Gas mixers for medical use—Stand-alone gas mixers YY 0893-2013 Medical gas mixer/independent gas mixer

Referenced Standards

GB/T 3767-2016 Acoustics—Determination of sound power levels and sound energy levels of noise sources using sound pressure—Engineering methods for an essentially free field over a reflecting plane GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance ISO 7396-1 ISO 10524-1 ISO 11114-3 EN 13544-2:2002 GB 9706.255-2022 Medical electrical equipment—Part 2-55:Particular requirements for the basic safety and essential performance of respiratory gas monitors YY/T 0316-2003 Medical devices—Application of risk management to medical devices YY/T 0316-2008 Medical devices—Application of risk management to medical devices YY/T 0316-2016 Medical devices—Application of risk management to medical devices YY/T 0799-2010 Low-pressure hose assemblies for use with medical gases YY/T 0801.1-2010 Terminal units for medical gas pipeline systems—Part 1:Terminal units for use with compressed medical gases and vacuum YY/T 0882-2013 Anaesthetic and respiratory equipment—Compatibility with oxygen YY 9706.108-2021 Medical electrical equipment—Part 1-8:General requirements for basic safety and essential performance-Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems YY/T 0316-2000 YY/T 0316-2000 Medical devices - Risk analysis - Part 1: Application of risk analysis GB 50751-2012 Technical code for medical gases engineering

Adopt standards

ISO 11195:2018

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