ISO 13408-7:2012

This standard was last reviewed and confirmed in 2018. Therefore this version remains current.

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
Edition
: 1

Number of pages
: 19
Technical Committee
: ISO/TC 198 Sterilization of health care products
ICS
:
11.080.01 Sterilization and disinfection in general

This standard contributes to the following Sustainable Development Goal:

Good Health and Well-being

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	Format	Language
std 1 124	PDF + ePub
std 2 124	Paper
std 3 124	PDF

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ISO 13408-7:2012

A standard is reviewed every 5 years
Stage: 90.20 (Under review)

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