EN ISO 13408-7:2015

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system elements
5 Aseptic process definition
6 Manufacturing environment
7 Equipment
8 Personnel
9 Manufacture of the product
10 Process simulation
11 Test for sterility
Annex A (informative) - Risk assessment for aseptic
        processing - Quality risk management method
Annex B (informative) - Selection of a sample for testing
        for microbial contamination
Annex C (informative) - Testing options for process
        simulation
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU Directive
         90/385/EEC on active implantable medical devices
Annex ZB (informative) - Relationship between this European
         Standard and the Essential Requirements of EU Directive
         93/42/EEC on medical devices
Annex ZC (informative) - Relationship between this European
         Standard and the Essential Requirements of EU Directive
         98/79/EC on in vitro diagnostic medical devices

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.