This Standard specifies the requirements and test methods for sterile insulin syringe for single use (hereinafter referred to as syringe). The syringe is used only once and is used for human injection immediately after aspiration of insulin. This Standard applies to syringes for use with 40 units of insulin/ml (U-40) and 100 units of insulin/ml (U-100). This Standard does not apply to syringes for long-term storage of insulin.
Basic Data
Standard ID
YY/T 0497-2018 (YY/T0497-2018)
Description (Translated English)
Sterile insulin syringe for single use
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C31
Word Count Estimation
25,263
Date of Issue
2018-04-11
Date of Implementation
2019-05-01
Older Standard (superseded by this standard)
YY 0497-2005
Regulation (derived from)
China Drug Administration Announcement No. 4 of 2018
