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This standard has been prepared by CEN/TC 102 "Sterilizers for medical purposes" (secretariat: DIN, Germany). Working Committee NA 063-04-04 AA "Sterilgutversorgung" ("Sterile supply") of DIN Standards Committee Medicine (NAMed) at the German Institute for Standardization e. V. is responsible for this standard. This part of EN 868 provides test methods and values for materials for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add or modify the general requirements specified in EN ISO 11607-1.
This document replaces DIN EN 868-2:2009-09 .