YY/T 1469-2025: Electrical infusion pump for ambulatory use

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Scope

This Standard specifies the basic requirements for electrical infusion pump for ambulatory use
and describes the corresponding test methods.
This document applies to electrical infusion pumps for ambulatory use in medical monitoring
environments.
This document does not apply to the following equipment.
---Enteral nutrition pumps;
---Insulin pumps and pumps with similar clinical applications;
---Other special-purpose electrical infusion pumps for ambulatory use with special
requirements for infusion accuracy.
NOTE. for explanations of the scope and related clauses, please refer to Appendix A.

Basic Data

Standard ID	YY/T 1469-2025 (YY/T1469-2025)
Description (Translated English)	Electrical infusion pump for ambulatory use
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C31
Classification of International Standard	11.040.20
Word Count Estimation	21,279
Date of Issue	2025-10-30
Date of Implementation	2027-11-01
Older Standard (superseded by this standard)	YY/T 1469-2016
Issuing agency(ies)	National Medical Products Administration
Summary	This standard specifies the basic requirements for portable electric infusion pumps and describes the corresponding test methods. This standard applies to portable electric infusion pumps used in medical monitoring environments. This standard does not apply to the following equipment: enteral nutrition pumps; insulin pumps and pumps with similar clinical applications; other dedicated portable electric infusion pumps with special requirements for infusion accuracy.