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

ISO-13408-7 - 1ST EDITION - CURRENT


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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.

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Document Number

ISO 13408-7:2012

Revision Level

1ST EDITION

Status

Current

Publication Date

Aug. 1, 2012

Committee Number

ISO/TC 198