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ANSI/AAMI/ISO 11607-1:2019

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems, and packaging systems.

Specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.

Association for the Advancement of Medical Instrumentation [aami]

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