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

Publish Date: 2025-10-30 Implement Date: 2027-11-01 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: 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
Pages: 24 pages

Scope

This document specifies the basic requirements for portable electric infusion pumps and describes the corresponding test methods.
This document is applicable to portable electric infusion pumps used in medical monitoring environments.
This document is not applicable to the following devices:
—— Enteral nutrition pumps;
—— Insulin pumps and similar pumps for clinical applications;
—— Other specialized portable electric infusion pumps with special requirements for infusion accuracy.
Note: For an explanation of the scope and related provisions, please refer to Appendix A.

Development Information

Word Count: 35 Thousand words Pages: 24 pages

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

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