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NEN 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

01-09-2015

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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.

DevelopmentNote
Supersedes NEN ISO 13408-7. (08/2015)
DocumentType
Standard
PublisherName
Netherlands Standards
Status
Current
Supersedes

Standards Relationship
EN ISO 13408-7:2015 Identical
ISO 13408-7:2012 Identical

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