EN 868-7:2017 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
This European Standard specifies test methods and values for sealable adhesive coated paper manufactured from paper complying with EN 868-6, 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. The materials specified in this part are intended to be used for ethylene oxide or irradiation sterilization. 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 868-7:2017 Referenced Document
EN 1041:2008 Information supplied by the manufacturer of medical devices
EN 20187:1993 Paper, board and pulps; standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples (ISO 187:1990)
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 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
EN ISO 1974:2012 Paper - Determination of tearing resistance - Elmendorf method (ISO 1974:2012)
ISO 2470-2:2008 Paper, board and pulps - Measurement of diffuse blue reflectance factor - Part 2: Outdoor daylight conditions (D65 brightness)
ISO 3689:1983 Paper and board; Determination of bursting strength after immersion in water (Revision of ISO 3689-1976)
ISO 3781:2011 Paper and board - Determination of tensile strength after immersion in water
ISO 5636-3:2013 Paper and board.Determination of air permeance (medium range) .Part 3: Bendtsen method
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 868-7:2017 history
2017EN 868-7:2017 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
2009EN 868-7:2009 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
1999EN 868-7:1999 Packaging Materials and Systems for Medical Devices Which are to Be Sterilized - Part 7: Adhesive Coated Paper for the Manufacture of Heat Sealable Packs for Medical Use for Sterilization by Ethylene Oxide or Irradiation - Requirements and Test Methods