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.