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The ISO 11607 standard is conveniently split into the two following parts, covering the demands on packaging for terminally sterilized medical devices.
ISO 11607 1: Part one establishes the requirements and methods for testing the sterile barrier systems and packaging systems. To make sure that they remain terminally sterilized from factory to end user.
ISO 11607 2: Part two sets out the process requirements on a manufacturer when creating a sterile barrier system for their medical devices. What they should do to minimize any risk of contamination in the factory and through the supply chain. And how they should do it.
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