This document specifies test methods and values for uncoated nonwoven materials of polyolefines used for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. Other than the general requirements as specified in EN ISO 11607 1 and EN ISO 11607 2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this European Standard. The materials specified in this part of EN 868 are intended for single use only.
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ASTM D 2724:2007 Standard Test Method for Bond Strength of Bonded, Fused, and Laminated Apparel Fabrics
EN ISO 11607-1:2017 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, including Amd 1:2014)
EN ISO 1924-2:2008 Paper and board - Determination of tensile properties - Part 2: Constant rate of elongation method (20 mm/min) (ISO 1924-2:2008)
ASTM D 2724:2007 Standard Test Method for Bond Strength of Bonded, Fused, and Laminated Apparel Fabrics
EN ISO 11607-1:2017 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, including Amd 1:2014)
EN ISO 1924-2:2008 Paper and board - Determination of tensile properties - Part 2: Constant rate of elongation method (20 mm/min) (ISO 1924-2:2008)
EN ISO 1974:2012 Paper - Determination of tearing resistance - Elmendorf method (ISO 1974:2012)
EN ISO 2758:2014 Paper - Determination of bursting strength (ISO 2758:2014)
EN ISO 536:2020 Paper and board - Determination of grammage (ISO 536:2019)
EN ISO 811:2018 Textiles - Determination of resistance to water penetration - Hydrostatic pressure test (ISO 811:2018)
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