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EN 868-5 seal strength testing

EN 868-5 Packaging for terminally sterilized medical devices – Part 5: Sealable pouches and reels of porous materials and plastic film construction – Requirements and test methods

Annex D of EN 868-5 covers the measurement of the strength of seals in pouches and reel material. The test measures the force needed to separate a test strip of the material containing the seal.

Test Summary

The seal strength of the pouch or reel material is measured by cutting a sample strip at 90° through the seal and measuring the maximum force needed to separate the seal.

Test Procedure

Representative samples of the material are cut to 15 ± 0.0 mm width perpendicular to the seal. The length of the specimen should be sufficient to be accommodated in the testing apparatus. Each leg of the specimen is gripped in the fixed and moving jaws of the force testing stand so the seal is equidistant between the two grips, and aligned laterally so the seal is perpendicular to the direction of movement of the grips. It may be necessary to support the tail of the sample, if so report the method used.

Test Apparatus

Tensile tester with grips and suitable range loadcell. This may be a vertical testing stand, or alternatively a horizontally oriented machine.

Cutting apparatus

Preparation

Cut a sufficient quantity of strips from a representative sample to a width of 15 ± 0.1mm perpendicular to the seal, and of sufficient length so as to able to be easily clamped in the fixed and moving grips of the test stand. Expose the pouch or reel material to the intended sterilization cycle in accordance with the relevant European standard.

Method

  • 1. Cut strips from the sample to the dimensions defined in the standard.
  • 2. Sterilize the test strips in accordance with the relevant standards
  • 3. Clamp the ends of the sample strip into the jaws of the tensile tester with the seal perpendicular to the direction of movement, and equidistant between the fixed and moving jaws.
  • 4. If required, support the tail of the test specimen.
  • 5. Set the tensile tester in motion at a speed of 200 ± 10 mm/min.
  • 6. Record the tensile force and displacement as the seal is peeled apart.

Report

  • Record all details necessary to identify the sample including width and machine direction in relation to the direction of pull.
  • Report the speed of separation used by the tensile tester, and the method used to support the tail of the sample if appropriate.
  • Report the maximum tensile force in newtons per 15 mm width encountered as the specimen is peeled apart.

Mecmesin Test Equipment Required for EN 868-5

FPT-H1 Horizontal Friction Peel Tear Tester

or

Please refer to the latest official European standard for more detailed information.
This overview is intended to provide a basic understanding of the test procedure and suitable equipment to meet the standard.

EN 868-5 seal strength testing


EN 868-5 seal strength testing

The test can be done horizontally or vertically


EN 868-5 seal strength testing

Preparing the samples


EN 868-5 seal strength testing

Real-time graphing & results