DIN EN ISO 14937:2010-03

This Standard specifies general requirements for the characterization of a sterilizing agent, and for the development, validation, and routine monitoring and control of a sterilization process for medical devices.Note Although the scope of this International Standard is limited to medical devices, the requirements specified herein can also be applied to sterilization processes for other health care products.This Standard applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means.