GB 15811-2025: Sterile hypodermic needles for single use

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Newer / historical versions: GB 15811-2025

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Scope

This document specifies the requirements for sterile hypodermic needles for single use
(hereinafter referred to as the “hypodermic needles”) whose needle tubing has a nominal outer
diameter of 0.18 mm ~ 1.2 mm.
This document applies to hypodermic needles used in conjunction with GB 15810 and other
suitable injection devices for intradermal, subcutaneous, intramuscular and intravenous
injection of liquid medications. For single-use hypodermic needles used in conjunction with
GB 15810 and provided in a non-sterile state, this document may be taken as a reference.
This document does not apply to single-use dental syringe needles, needles used with needle
injection systems (NIS) or single-use dispensing needles.

Basic Data

Standard ID	GB 15811-2025 (GB15811-2025)
Description (Translated English)	Sterile hypodermic needles for single use
Sector / Industry	National Standard
Classification of Chinese Standard	C31
Classification of International Standard	11.040.20
Word Count Estimation	22,271
Date of Issue	2025-08-29
Date of Implementation	2028-09-01
Older Standard (superseded by this standard)	GB 15811-2016
Issuing agency(ies)	State Administration for Market Regulation; Standardization Administration of China