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Norm
ÖNORM EN ISO 13408-7
Issue date: 2015 11 15
Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)
This part of ISO 13408 specifies requirements and provides guidance on alternative approaches to process simulations for the qualification of the aseptic processing of me...
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Valid
Publisher:
Austrian Standards International
Format:
Digital | 35 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
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.
ÖNORM EN ISO 13408-7
2015 11 15
Aseptic processing of health care products - Part 7: Alternative processes for medical devices and c...
Norm
↖
Norm
ISO 13408-1:2008
Issue date :
2008 06 10
Aseptic processing of health care products — Part 1: General requirements
Norm
ISO 13408-7:2012
Issue date :
2012 07 31
Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products