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Status : Active
Standard Type : Main
Document No : ISO 13408-7:2012
Document Year : 2012
Pages : 19
Edition : 1
Section Volume : Sterilization of health care products (ISO/TC 198.)
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.