Refer Standards
EN ISO 8537:2007 Sterile single-use syringes, with or without needle, for insulin.
EN ISO 9626:1991 / AMD. 1: 2001 Stainless steel needle tubing for the manufacture of medical devices AMENDMENT 1.
ASTM F88/F88M-09 Standard Test Method for Seal Strength of Flexible Barrier Materials.
ASTM F1140/F1140M -13 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages.
ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals.
USP 37- NF32 2014: U.S. Pharmacopeia National Formulary.
Sterile insulin syringe for single use ( with needle)
Sizes: 0.5ml, 1ml.
SPEC: U-40, U-80
Product structure: barrel, plunger, piston, and sterile hypodermic needle
Product instruction: The products are made by medical polymer materials. Sterilized by EO gas; sterile, non-toxic, pyrogen free. The needles on barrels are dead space, without residual volumn, ultra thin wall needle cannula, highly sharp needle point, clear and accurate graduation. This makes easy identification, no counting and accurate medication dosage. And the double-wall sealed package makes easy bringing safe use.
Technical indication: in accordance with GB15810
Scope for use:
The products are used for the injection of insulin drug.
Refer Standards
ISO 9626: 1991 + AMENDMENT 1 2001 Stainless steel needle tubing for the manufacture of medical devices.
ISO 8537:2007 Sterile single-use syringes, with or without needle, for insulin.
ISO 10993-7:2008 Biological evaluation of medical devices - Part 7 : Ethylene oxide sterilization residuals.
ASTM F 1140/F 1140M-13 Standard test methods for internal pressurization failure resistance of unrestrained packages.
USP 37-NF 32 <85> Bacterial Endotoxins Limit.
ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Test of sterility performed in the definition, validation and maintenance of a sterilization process.
ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
The integrated design of the needle holder and barrel injection molding
which ensures the low residue of the liquid and ensures the accuracy of
the injection of the liquid.
Excellent sliding performance, convenient for clinical injection operation
medical staff.
