ANSI/AAMI/ISO 11607-1:2019 (PDF)
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This standard 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.
Date of Publication: 24 May 2019
Pages: 57
ISBN: 978-1-57020-721-1