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ISO 13408-7:2012

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products

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.


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International Organization for Standardization [iso]


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ISO 13408-1:2008
Aseptic processing of health care products - Part 1: General requirements
ISO 13408-5:2006
Aseptic processing of health care products - Part 5: Sterilization in place
ISO 13408-2:2018
Aseptic processing of health care products - Part 2: Sterilizing filtration
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