ISO 13408-7:2012
Aseptic processing of health care products -- Part 7: Alternative processes for medical devices and combination products
Product Details
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.