ISO 11607-1: Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems

ISO 11607 part 1 specifies the 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.

Appendix B of this standard summarizes the relevant test methods such as paper and plastic specifications as well as performance testing of the complete package.