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The standard has been prepared by CEN/TC 102 "Sterilizers for medical purposes" (secretariat: DIN, Germany). At DIN, the German Institute for Standardization e. V., DIN Standards Committee Medicine (NAMed) of Working Committee NA 063-04-04 AA "Sterilgutversorgung" ("Sterile supply") was responsible for its preparation. This part of EN 868 provides test methods and values for paper, used in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) used as 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 868-3:2009-09 .