BS EN 868-7:2017
Packaging for terminally sterilized medical devices. Adhesive coated paper for low temperature sterilization processes. Requirements and test methods

Standard No.
BS EN 868-7:2017
Release Date
2017
Published By
British Standards Institution (BSI)
Latest
BS EN 868-7:2017
Replace
BS EN 868-7:2009

BS EN 868-7:2017 Referenced Document

  • 93/42/EEC Commission communication in the framework of the implementation of the Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance; Publication of titles and references of harmonised standards under the directive)
  • EN 1041 Information supplied by the manufacturer of medical devices
  • EN 20187 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 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 1924-2 Paper and board - Determination of tensile properties - Part 2: Constant rate of elongation method (20 mm/min) (ISO 1924-2:2008)*2023-12-23 Update
  • EN ISO 1974 Paper - Determination of tearing resistance - Elmendorf method (ISO 1974:2012)
  • EN ISO 2758 Paper - Determination of bursting strength
  • EN ISO 535 Paper and board - Determination of water absorptiveness - Cobb method (ISO 535:2023)*2023-04-05 Update
  • EN ISO 536 Paper and board - Determination of grammage (ISO 536:2019)*2020-02-05 Update
  • ISO 11607-2 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1
  • ISO 187 Paper, board and pulps; standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples*2022-01-01 Update
  • ISO 1924-2 Paper and board - Determination of tensile properties - Part 2: Constant rate of elongation method (20 mm/min)
  • ISO 1974 Paper - Determination of tearing resistance - Elmendorf method
  • ISO 2470-2 Paper, board and pulps - Measurement of diffuse blue reflectance factor - Part 2: Outdoor daylight conditions (D65 brightness)
  • ISO 2758 Paper - Determination of bursting strength
  • ISO 3689 Paper and board; Determination of bursting strength after immersion in water (Revision of ISO 3689-1976)
  • ISO 3781 Paper and board - Determination of tensile strength after immersion in water
  • ISO 535 Paper and board — Determination of water absorptiveness — Cobb method*2023-03-13 Update
  • ISO 536 Paper and board — Determination of grammage*2019-11-25 Update
  • ISO 5636-3 Paper and board.Determination of air permeance (medium range) .Part 3: Bendtsen method
  • 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 868-7:2017 history

  • 2017 BS EN 868-7:2017 Packaging for terminally sterilized medical devices. Adhesive coated paper for low temperature sterilization processes. Requirements and test methods
  • 2009 BS EN 868-7:2009 Packaging for terminally sterilized medical devices - Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
  • 1999 BS EN 868-7:1999 Packaging materials and systems for medical devices which are to be sterilized - Adhesive coated paper for the manufacture of heat sealable packs for medical use for sterilization by ethylene oxide or irradiation - Requirements and test methods
 Packaging for terminally sterilized medical devices. Adhesive coated paper for low temperature sterilization processes. Requirements and test methods



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