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60.60 Standard published Aug 5, 2015
CEN
CEN/TC 204 Sterilization of medical devices
European Norm
11.080.01 Sterilization and disinfection in general
Published
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.
Legislation related to this standard
PUBLISHED
EN ISO 13408-7:2015
60.60
Standard published
Aug 5, 2015