Standard: AAMI 13408-7

ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS

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Scope:

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.

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami 13408-7
Publish Date: 2012-01-01
Page Count: 36
Change Type: NEW ADDITION
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: YES
Status: Active

This Standard References

Showing 9 of 9.

EU/EC 2004/23/EC
EU/EC 2005/17/EC
ISO 14644 SET

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