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.
Status: PublishedPublication date: 2012-08
Edition: 1Number 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:
Buy this standard
|std 1 124||PDF + ePub|
|std 2 124||Paper|
|std 3 124|
A standard is reviewed every 5 years
Stage: 90.60 (Under review)
Got a question?
Check out our FAQs
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)
Keep up to date with ISO
Sign up to our newsletter for the latest news, views and product information.