ÖNORM EN ISO 20857

This International Standard specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices. Although this International Standard primarily addresses dry heat sterilization, it also specifies requirements and provides guidance in relation to depyrogenation processes using dry heat. This International Standard does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. This International Standard does not apply to processes that use infrared or microwaves as the heating technique. This International Standard does not detail a specified requirement for designating a medical device as "sterile." This International Standard does not specify a quality management system for the control of all stages of production of medical devices. This International Standard does not specify requirements for occupational safety associated with the design and operation of dry heat sterilization and/or depyrogenation facilities.