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EN ISO 13408-7:2015 Standard

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  Keywords:

#process #aseptic #part #simulation #cannot

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

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

  Purpose

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.

  Publication

Friday 17th of November 2017

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