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Sep 24, 2012

11 Frequently Asked Questions about ISO 11607-1

Sep 24, 2012|Package Integrity, Packaging Validation, Uncategorized|

By Patrick J. Nolan, President of DDL, Inc. and Karen K. Greene, VP of Sales/Technology at Life Packaging Technology. ISO 11607, the foremost guidance document for validating packaging for terminally sterilized medical devices, was revised early in 2006.  The updated ISO 11607-1 standard contains revisions to package validation requirements including sample size, labeling, documentation and [...]

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