scope:

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 microbal inactivation.

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

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

NOTE 1 Although the scope of this International Standard is limited to medical devices, the principles described may also be applied to other health care products.

NOTE 2 Sterlization processes validated and controlled in accordance with the requirements of this Internaitonal Stanard should not be assumed to be effective in inactivating the causative agents of spongiform encephalopathy and Creulzfeild-Jakob disease. Specific remmendations have been produced in particular countries for the processing of materials potentially contaiminated with these agents.