DIN EN 868-4:2009 PDF

Scope: This part of EN 868 provides test methods and values for paper bags manufactured from paper specified in Part 3 of EN 868, 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. 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 or modify the general requirements specified in EN ISO 11607-1. As such, the particular requirements in 4.2 to 4.6 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. The materials specified in this part of EN 868 are intended for single use only. 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.

DIN EN 868-4:2009 Referenced Document

EN 868-3 Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods*， 2017-02-01 Update
EN ISO 11140-1 Sterilization of health care products - Chemical indicators - Part 1: General requirements*， 2014-11-01 Update
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
ISO 6588-2:2005 Paper, board and pulps - Determination of pH of aqueous extracts - Part 2: Hot extraction
ISO 8601 Data elements and interchange formats - Information interchange - Representation of dates and times
ISO 9197 Paper, board and pulps - Determination of water-soluble chlorides*， 2016-08-01 Update
ISO 9198 Paper, board and pulp — Determination of water-soluble sulfates*， 2020-09-18 Update

2017 DIN EN 868-4:2017-05 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods; German version EN 868-4:2017
2017 DIN EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods; German version EN 868-4:2017
2009 DIN EN 868-4:2009 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods; English version of DIN EN 868-4:2009-09
0000 DIN EN 868-4:2007
0000 DIN EN 868-4:1999