Sterilisering av medicintekniska produkter - Torr värme - Krav för utveckling, validering och rutinkontroll av steriliseringsprocesser för medicintekniska produkter (ISO 20857:2010, IDT)
SS-EN ISO 20857:2013
1.1.1 This International Standard specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices.
NOTE Although the scope of this International Standard is limited to medical devices, it specifies requirements and provides guidance that might be applicable to other health care products.
1.1.2 Although this International Standard primarily addresses dry heat sterilization, it also specifies requirements and provides guidance in relation to depyrogenation processes using dry heat.
NOTE Dry heat is often used for the depyrogenation of equipment, components and health care products and its effectiveness has been demonstrated. The process parameters for sterilization and/or depyrogenation are time and
temperature. Because the conditions for depyrogenation are typically more severe than those required for sterilization, a process that has been validated for product depyrogenation will result in product sterility without additional validation.
1.2.1 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.
NOTE See also ISO 22442-1, ISO 22442-2 and ISO 22442-3.
1.2.2 This International Standard does not apply to processes that use infrared or microwaves as the heating technique.
1.2.3 This International Standard does not detail a specified requirement for designating a medical device as "sterile."