This European Standard specifies test methods and values for paper bags manufactured from paper specified in EN 868-3, 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. 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.
EN 868-4:2017 Referenced Document
EN 1041:2008 Information supplied by the manufacturer of medical devices
EN 868-3:2009 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
EN ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements
EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)
EN ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels@ labelling and information to be supplied - Part 1: General requirements
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)*， 2024-04-20 Update
ISO 5725-2:1994 Accuracy (trueness and precision) of measurement methods and results - Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
ISO 6588-2:2012 Paper, board and pulps - Determination of pH of aqueous extracts - Part 2: Hot extraction
ISO 8601:2004 Data elements and interchange formats - Information interchange - Representation of dates and times
ISO 9197:2016 Paper, board and pulps - Determination of water-soluble chlorides
ISO 9198:2001 Paper, board and pulp - Determination of water-soluble sulfates
EN 868-4:2017 history
2017EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
2009EN 868-4:2009 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
1999EN 868-4:1999 Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 4: Paper Bags - Requirements and Test Methods