The principle guidance for validating terminally sterilized medical device packaging is ISO 11607. ISO 11607 is divided into two parts – Part 1, “Requirements for Materials, Sterile Barrier Systems and Packaging Systems” and Part 2, “Validation for Forming, Sealing, and Assembly Processes.” ISO 11607 improved the flow of package qualification and process validation by defining/harmonizing four key terms used throughout both parts of the standard.
For sterile barrier packaging systems, ISO 11607
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