GB/T 43952-2024 Active National standards

GB/T 43952-2024 Medical supply units

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

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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

Pages: 36 pages

Scope

This document specifies the basic safety and performance requirements for medical supply devices (also known as ME devices). This document applies to medical supply devices manufactured in factories or assembled on-site, including cabinets and boxes used to provide patient care services.

Development Information

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