This document specifies the basic requirements and corresponding test methods for portable infusion devices for single use - non electrically driven (hereinafter referred to as the infusion devices).
Basic Data
Standard ID
YY 0451-2023 (YY0451-2023)
Description (Translated English)
Portable infusion devices for single use - Non electrically driven
Sector / Industry
Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard
C47
Classification of International Standard
11.080.01
Word Count Estimation
18,134
Date of Issue
2023-09-05
Date of Implementation
2026-09-15
Older Standard (superseded by this standard)
YY 0451-2010
Issuing agency(ies)
State Drug Administration
Summary
This standard specifies the basic requirements and corresponding test methods for disposable portable infusion pumps - non-electrically driven (hereinafter referred to as infusion pumps). This standard applies to infusion pumps for continuous (fixed or adjustable) and/or self-controlled delivery of fluids for neurological, intravascular or subcutaneous applications. This document does not apply to: electric or electronically controlled infusion pumps covered by GB 9706.224; devices for single patient use for delivering discrete (bolus) medicinal liquids covered by the YY/T 1768 series; implantable devices; intestinal Feeding pump; transcutaneous infusion device; device in which infusion power is not provided by the device itself or obtained by active intervention of the patient (for example, a device powered only by gravity).
