scope:

This document specifically provides guidance on the application of ANSI/AAMI/ISO11607-1:2006, Packaging for terminally sterilized medical devices-Part 1: Requirements for materials, sterile barrier systems and packaging systems and ANSI/AAMI/ISO 11607-2:2006, Packaging for terminally sterilized medical devices-Part 2: Validation requirements for forming, sealing, and assembly processes within the regulatory framework of the United States Food and Drug Administration that exists at the time of the publication of this document. A significant portion of this guidance can be applied to other regulatory frameworks that exist globally but the user must use their expertise in making the appropriate judgment on applicability.