ISO 13408:2012
ISO 13408:2012 Aseptic processing of health care products – Part 7: Alternative processes for medical devices and combination products
CDN $251.00
Description
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.
Edition
1
Published Date
2012-07-31
Status
PUBLISHED
Pages
19
Language
English
Format
Secure PDF
Secure – PDF details
- Save your file locally or view it via a web viewer
- Viewing permissions are restricted exclusively to the purchaser
- Device limits - 3
- Printing – Enabled only to print (1) copy
See more about our Environmental Commitment
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.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-
ISO 24096:2024 Technical product documentation (TPD) – Classification of requirements – Part 2: Classification based on severity and susceptibility
CDN $251.00 Add to cart -
ISO 21531:2009 Dentistry – Graphical symbols for dental instruments
CDN $186.00 Add to cart -
ISO 15223:2025 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements – Amendment 1: Addition of defined term for authorized representative and modified EC REP symbol to not be country or region specific
CDN $33.00 Add to cart -
ISO 20537:2025 Footwear – Identification of defects during visual inspection – Vocabulary
CDN $295.00 Add to cart
