International Standards on Sterilization of Medical Devices

Both the Association for the Advancement of Medical Instrumentation (AAMI) and the International Organization for Standardization (ISO) have developed standards and viable validation guidelines for sterilization of medical devices. These standards often prepared in response to regulatory requirements related to good manufacturing practices and quality assurance.

Except ISO 10993-7 Biological Evaluation of Medical Devices-Ethylene Oxide Sterilization Residuals, other main standards on sterilization of medical devices can be learned in the ISO website. FDA also issued a guidance document.