BS EN 868-4:2017
Packaging for terminally sterilized medical devices. Paper bags. Requirements and test methods

Standard No.
BS EN 868-4:2017
Release Date
2017
Published By
British Standards Institution (BSI)
Latest
BS EN 868-4:2017
Replace
BS EN 868-4:2009

BS EN 868-4:2017 Referenced Document

  • EN 1041 Information supplied by the manufacturer of medical devices
  • 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
  • EN ISO 11140-1 Sterilization of health care products - Chemical indicators - Part 1: General requirements
  • EN ISO 11607-2 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1 (ISO 11607-2:2019/DAM 1:2022)
  • EN ISO 15223-1 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)*2021-09-29 Update
  • 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)*2023-12-24 Update
  • ISO 11140-1 Sterilization of health care products - Chemical indicators - Part 1: General requirements
  • ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
  • ISO 11607-2 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1
  • ISO 15223-1 Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements — Amendment 1
  • ISO 1924-2 Paper and board - Determination of tensile properties - Part 2: Constant rate of elongation method (20 mm/min)
  • ISO 5725-2 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*2019-12-06 Update
  • ISO 6588-2:2012 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
  • ISO 9198 Paper, board and pulp — Determination of water-soluble sulfates*2020-09-18 Update

BS EN 868-4:2017 history

  • 2017 BS EN 868-4:2017 Packaging for terminally sterilized medical devices. Paper bags. Requirements and test methods
  • 2009 BS EN 868-4:2009 Packaging for terminally sterilized medical devices - Paper bags - Requirements and test methods
  • 1999 BS EN 868-4:1999 Packaging materials and systems for medical devices which are to be sterilized - Paper bags - Requirements and test methods
 Packaging for terminally sterilized medical devices. Paper bags. Requirements and test methods



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