This International Standard specifies general requirements for the characterization of a sterilizing agent, and for the development, validation and routine control of a sterilization process for medical devices.

This International Standard applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means.

This International Standard does not apply to processes that rely solely on physical removal of microorganisms (for example, filtration).

This International Standard does not describe detailed test procedures for assessing microbial inactivation.

This International Standard is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organization with responsibility for sterilizing the medical device.

This International Standard does not supersede or modify published International Standards for particular sterilization processes.