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ISO 13408-7:2012

Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products

Jul 31, 2012

General information

90.93     Sep 28, 2023

ISO

ISO/TC 198

International Standard

11.080.01  

English   French   Russian  

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Scope

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.

Life cycle

NOW

PUBLISHED
ISO 13408-7:2012
90.93 Standard confirmed
Sep 28, 2023

National adoptions

SRPS EN ISO 13408-7:2016  
ISS

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

60.60   Standard published

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