This Standard specifies classification, requirements, test methods, inspection rules, marks, operation instructions, packaging, transportation, storage, etc. for insulin syringe for single-use. It covers syringes for use with 40 units of insulin/ml (U-40) and 100 units of insulin/ml (U-100). This Standard applies to the insulin syringe for single-use that injects into human body soon after extracting insulin liquid (hereinafter refereed to as syringe). This Standard does not apply to sterile syringe for single-use, glass syringe for single-use, and prefilled syringe.
Basic Data
Standard ID
YY 0497-2005 (YY0497-2005)
Description (Translated English)
Sterile insulin syringe for single use
Sector / Industry
Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard
C31
Classification of International Standard
11.040.20
Word Count Estimation
23,289
Date of Issue
2005-12-07
Date of Implementation
2006-12-01
Adopted Standard
ISO 8537-1991, NEQ
Regulation (derived from)
Industry Standard Notice 2006 No. 2 (No. 74 overall)
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies the classification of disposable insulin syringes, requirements, test methods, inspection rules, marking, manual, packaging, transportation and storage requirements. It consists of 40 units of insulin syringe (U-40) and 100 units of insulin syringe (U-100). This standard applies to pumping insulin human injection immediately after liquid disposable insulin syringes (hereinafter referred to as the syringe). Does not apply to one-time use of sterile syringes, disposable glass syringe, pre-injection of liquid syringes.
