ANSI/AAMI/ISO 11135

ANSI/AAMI/ISO 11135 is a set of international standards that outlines methods for sterilizing medical devices using ethylene oxide gas. This standard ensures that the sterilization process effectively kills all harmful microorganisms without damaging the devices. It provides guidelines for validating and monitoring the sterilization process, helping manufacturers ensure the safety and reliability of medical products. Adhering to this standard promotes consistency and quality in the healthcare industry, ultimately enhancing patient safety and reducing the risk of infections from contaminated instruments.