TSE - TS EN ISO 13408-7
Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products
active, Most Current
| Organization: | TSE |
| Publication Date: | 23 October 2015 |
| Status: | active |
| ICS Code (Sterilization and disinfection in general): | 11.080.01 |
scope:
This part of ISO 13408 specifies requirements and providesguidance on alternative approaches to process simulations for thequalification of the aseptic processing of medical devices andcombination products that cannot be terminally sterilized and wherethe process simulation approach according to ISO 13408-1 cannot beapplied.
Document History
TS EN ISO 13408-7
October 23, 2015
Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products
This part of ISO 13408 specifies requirements and providesguidance on alternative approaches to process simulations for thequalification of the aseptic processing of medical devices andcombination...