1.1 This International Standard specifies general requirements for the characterization of a sterilizing agent, and for the deve lopment, validation and routing control of a sterilization process for medical devices.
1.2 This International Standard applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means.
1.3 This International Standard does not apply to processes that rely solely on physical removal of microorganisms (for example, filtration).
1.4 This International Standard does not describe detailed test procedures for assessing microbial inactivation.
1.5 This International Standard is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and organization with responsibility for sterilizing the medical device.
1.6 This International Standard does not supersede or modify published International Standards for particular sterilization processes.
(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.
(2) Sterilization processes validated and controlled in accordance with the requirements of this International Standard should not be assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.a