ISO 13408-7:2012

Published (Edition 1, 2012)

This publication was last reviewed and confirmed in 2023. Therefore this version remains current.

ISO 13408-7:2012

CHF 129

Convert Swiss francs (CHF) to your currency

Abstract

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.

General information

Status
: Published

Publication date
: 2012-08

Stage
: International Standard confirmed [90.93]
Edition
: 1

Number of pages
: 19
Technical Committee :
ISO/TC 198

ICS :
11.080.01
RSS updates