Safety Slide Insulin Syringe EO Sterilization 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.
Insulin Syringe EO Sterilization 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 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.
Safety Insulin Pen Needle EO Sterilization Packaging Config : TBD Features and Benefits: Sterile pack, single use only. Caina patented product. Color coded for easy identification of needle sizes. Ultra-sharp needle tip minimizes patient discomfort. Needle stick prevention, safety assured. Unique needle lubrication process, most comfort injection. Mini design for easy carrying. Red indication for activation. All materials are latex & DEHP free.