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ČSN EN ISO 13408-7 (855264)
Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products
Automatically translated name:
Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (standard for direct use as CSN).
STANDARD published on 1.2.2016
The information about the standard:
Designation standards: ČSN EN ISO 13408-7
Classification mark: 855264
Catalog number: 98850
Publication date standards: 1.2.2016
SKU: NS-626361
The number of pages: 36
Approximate weight : 108 g (0.24 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
The category - similar standards:
Annotation of standard text ČSN EN ISO 13408-7 (855264):
This part of ISO 13408 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.
This part of ISO 13408 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
