DIN EN 868-10:2009 PDF

Scope: This part of EN 868 provides test methods and values for sealable adhesive coated nonwoven materials of polyolefines, manufactured from nonwovens complying with EN 868-9 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. NOTE 1 The need for a protective packaging may be determined by the manufacturer and the user. 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 nor modify the general requirements specified in EN ISO 11607-1. As such, the particular requirements in 4.2 to 4.3 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. NOTE 2 When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, container filter, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, may apply. The materials specified in this part of EN 868 are intended for single use only.

DIN EN 868-10:2009 Referenced Document

EN 20811 Textiles - Determination of Resistance to Water Penetration - Hydrostatic Pressure Test
EN 21974 Paper - Determination of Tearing Resistance (Elmendorf Method) (ISO 1974:1990)
EN ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials@ sterile barrier systems and packaging systems
EN ISO 1924-2 Paper and board - Determination of tensile properties - Part 2: Constant rate of elongation method (20 mm/min) (ISO 1924-2:2008)*， 2024-04-19 Update
EN ISO 2758 Paper - Determination of bursting strength*， 2014-08-01 Update
ISO 5636-3 Paper and board.Determination of air permeance (medium range) .Part 3: Bendtsen method*， 2013-11-01 Update
ISO 6588-2 Paper, board and pulps — Determination of pH of aqueous extracts — Part 2: Hot extraction*， 2021-11-23 Update
ISO 8601 Data elements and interchange formats - Information interchange - Representation of dates and times

2019 DIN EN 868-10:2019-03 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods; German version EN 868-10:2018
2019 DIN EN 868-10:2019 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
1970 DIN EN 868-10 E:2017-08 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
2017 DIN EN 868-10 E:2017 Draft Document - Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods; Version allemande et anglaise prEN 868-10:2017
2009 DIN EN 868-10:2009 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods; English version of DIN EN 868-10:2009-09
0000 DIN EN 868-10:2007
0000 DIN EN 868-10:2000