UNI EN ISO 13408-7 : 2015
Current
Current
The latest, up-to-date edition.
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS
Published date
01-10-2015
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Defines 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.
| Committee |
CT 44
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Current
|
| Standards | Relationship |
| ISO 13408-7:2012 | Identical |
| EN ISO 13408-7:2015 | Identical |
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