YY/T 0497-2025: Sterile insulin syringe for single use

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Scope

This document specifies the requirements for sterile insulin syringe for single use
(hereinafter referred to as syringe) and describes the corresponding test methods. This
syringe is for single use only and is intended for immediate injection into the human
body after drawing up insulin.
This document applies to syringes used for injecting 40 units per milliliter (U-40) and
100 units per milliliter (U-100) of insulin.
This document does not apply to syringes used for long-term storage of insulin.

Basic Data

Standard ID	YY/T 0497-2025 (YY/T0497-2025)
Description (Translated English)	Sterile insulin syringe for single 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	30,317
Date of Issue	2025-09-15
Date of Implementation	2026-10-01
Older Standard (superseded by this standard)	YY/T 0497-2018
Issuing agency(ies)	National Medical Products Administration
Summary	This standard specifies the requirements for single-use sterile insulin syringes (hereinafter referred to as syringes) and describes the corresponding test methods. These syringes are for single use only and are intended for immediate injection into the human body after insulin aspiration. This document applies to syringes for injecting 40 units per milliliter (U-40) and 100 units per milliliter (U-100) of insulin. This document does not apply to syringes intended for long-term insulin storage.