GB/T 4506-1984
Abolished
YY/T 1469-2025
Pending
Industry standards-Medicine
YY/T 1469-2025 Electrical infusion pump for ambulatory use
YY/T 1469-2025 Electrical infusion pump for ambulatory use
Basic Information
Standard Code:
YY/T 1469-2025
Standard Type:
Industry standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Generally, it refers to microsurgical instruments
ICS Name:
Blood transfusion, infusion, and injection equipment
Publish Date:
2025-10-30
Implement Date:
2027-11-01
Publisher:
国家药品监督管理局
Technical Committee:
全国医用电器标准化技术委员会医用电子仪器标准化分技术委员会(SAC/TC 10/SC 5)
Pages:
24 pages
Scope
本文件规定了便携式电动输液泵的基本要求，描述了相应的试验方法。
本文件适用于医疗监护环境下使用的便携式电动输液泵。
本文件不适用于以下设备：
——肠内营养泵；
——胰岛素泵及相似临床应用的泵；
——其他对输液精度有特殊要求的专用便携式电动输液泵。
注： 对范围及相关条款的解释说明见附录A。
Development Information
Drafting Units:
上海市医疗器械检验研究院、河南驼人医疗器械集团有限公司、江苏省医疗器械检验所、江苏爱朋医疗科技股份有限公司
Drafting Persons:
徐超、杨巧洋、刘明媛、许海琴、蒋艺、董赟、高梦洁、李宁、韩强
Replace the following standards
Referenced Standards
GB/T 6682-1992 Water for analytical laboratory use—Specification and test methods
GB/T 6682-2008 Water for analytical laboratory use—Specification and test methods
GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety
GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety
GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance
GB 9706.224-2021 Medical electrical equipment—Part 2-24:Particular requirements for the basic safety and essential performance of infusion pumps and controllers
GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB/T 14233.3-2024 Test methods for infusion,transfusion,injection equipments for medical use—Part 3:Microbiological test methods
GB 15811-2001 Sterile hypodermic needles for single use
GB 15811-2016 Sterile hypodermic needles for single use
GB 15811-2025 Sterile hypodermic needles for single use
GB/T 43277.1-2023 Clamps and flow regulators for medical infusion and transfusion equipment—Part 1:Clamps and flow regulators without fluid contact
YY 0286.1-2019 Infusion sets for special purpose—Part 1:Infusion sets for single use with micropore filters
YY 0451-2023 Portable infusion devices for single use—Non electrically driven
YY 0585.4-2024 Fluid lines for use with pressure infusion equipment and accessories for single use—Part 4:Check valves
YY/T 0916.6-2022 Small-bore connectors for liquids and gases in healthcare applications—Part 6:Connectors for neuraxial applications
YY/T 0916.7-2024 Small-bore connectors for liquids and gases in healthcare applications—Part 7:Connectors for intravascular or hypodermic applications
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 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
Related Standards
GB/T 11751-1989
Abolished
GB/T 11751-1989 Flexible polymeric tubes for medical use—Dimension
GB/T 12256-1990
Abolished
GB/T 12256-1990 Test method for stiffness of hypodermic needle tubing
GB/T 13074-1991
Replaced
GB/T 13074-1991 Terms of blood purification—Hemodialysis and hemofiltration
GB 14232-1993
Abolished
GB 14232-1993 Bags for human blood and blood components
GB/T 14233.2-1993
Replaced