GB/T 43952-2024 Active National standards

GB/T 43952-2024 Medical supply units

Publish Date: 2024-06-29 Implement Date: 2025-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 43952-2024

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Surgical room equipment

ICS Name: Anesthesia, respiration, and resuscitation equipment

Publish Date: 2024-06-29

Implement Date: 2025-07-01

Publisher: 国家市场监督管理总局、国家标准化管理委员会

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

Pages: 36 pages

Scope

本文件规定了医用供应装置（也称为ME设备）的基本安全和基本性能的专用要求。本文件适用于在工厂中制造或现场装配的医用供应装置，包括用于提供患者护理服务的柜体和箱体。

Development Information

Drafting Units:

上海市医疗器械检验研究院、南京迈瑞生物医疗电子有限公司、上海德尔格医疗器械有限公司、四川港通医疗设备集团股份有限公司

Drafting Persons:

王伟、马小建、刘景伟、刘洪兵、刘世海、郁红漪、李新胜、陆冠勇、陈建明、周壮

Word Count: 50 Thousand words Pages: 36 pages

Referenced Standards

GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB/T 16895.24-2005 Electrical installations of buildings—Part 7-710:Requirements for special installations or locations— Medical locations GB/T 44059.1-2024 Medical gas pipeline systems—Part 1:Pipeline systems for compressed medical gases and vacuum ISO 5359:2014 ISO 7396-2:2007 ISO 9170-1:2017 ISO 16571 IEC 62680-1-1:2015 IEC 62684:2018 EN 50174-1 EN 50174-2 GB/T 3767-1996 Acoustics—Determination of sound power levels of noise sources using sound pressure—Engineering method in an essentially free field over a reflecting plane 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 7000.1-2002 General safety requirements and tests for luminaires GB 7000.1-2007 Luminaires—Part 1:General requirements and tests GB 7000.1-2015 Luminaires—Part 1:General requirements and tests GB/T 7000.1-2023 Luminaires—Part 1:General requirements and tests GB/T 42062-2022 Medical devices—Application of risk management to medical devices YY/T 0801.2-2010 Terminal units for medical gas pipeline systems—Part 2:Terminal units for anaesthetic gas scavenging systems YY 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests YY/T 9706.106-2021 Medical electrical equipment—Part 1-6:General requirements for basic safety and essential performance—Collateral Standard:Usability GB 50751-2012 Technical code for medical gases engineering

Adopt standards

ISO 11197:2019

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