ISO 13408-7:2012规定了要求，并提供了对不能终末消毒的医疗器械和组合产品的无菌处理资格的过程模拟的替代方法的指导，以及根据ISO 13408-1的过程模拟方法无法应用的指导。 ISO 13408-7:2012描述了在开发无菌过程期间如何使用风险评估来设计医疗器械和组合产品的过程模拟研究，在无菌处理过程中直接替代产品的介质是不可行的，不会模拟实际的无菌过程

ISO 13408-7:2012 specifies requirements and provides guidance on alternative approaches to process simulations for the qualification of the aseptic processing of medical devices and combination products that cannot be terminally sterilized and where the process simulation approach according to ISO 13408-1 cannot be applied. ISO 13408-7:2012 describes how risk assessment can be used during the development of an aseptic process to design a process simulation study for medical devices and combination products in those cases where a straightforward substitution of media for product during aseptic processing is not feasible or would not simulate the actual aseptic process.