Skip to main content
Back

EVS-EN ISO 13408-7:2015

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)

General information

Valid from 02.09.2015
Base Documents
ISO 13408-7:2012; EN ISO 13408-7:2015
Directives or regulations
None

Standard history

Status
Date
Type
Name
02.09.2015
Main
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.

Required fields are indicated with *

*
*
*
PDF
19.52 € incl tax
Paper
19.52 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring

Customers who bought this item also bought

Main

EVS-EN ISO 13408-1:2015

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
Withdrawn from 02.05.2024
Main

EVS-EN ISO 13408-4:2011

Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
Newest version Valid from 03.08.2011
Main

EVS-EN ISO 13408-5:2011

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
Newest version Valid from 03.08.2011
Main

EVS-EN ISO 13408-2:2018

Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)
Newest version Valid from 02.04.2018