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STANDARD

Current

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 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.

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General information on ÖNORM EN ISO 13408-7

Format

Paper | 35 Pages

Language

German | English | Download GER/ENG

Publisher

Austrian Standards International

Committee 215 Sterilization and disinfection of medical devices

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Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer	Titel	Ausgabedatum	Art	Link
Dokumentnummer ISO 13408-1:2008	Titel Aseptic processing of health care products — Part 1: General requirements	Ausgabedatum 2008 06 10	Art Standard	Zur Produktseite

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