EN 868-5  Test Fixture

Description

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

EN 868-5 characterizes the seal strength of single-use sterilized medical packaging.

This standard specifically focuses on packaging materials and systems for medical devices which need to be sterilized.

The seal strength identifies the adhesion strength between the two materials of the packaging; typically, a coated paper backing, and a plastic film overlay.

This standard is technically equivalent to ASTM F88 with minor differences in the specimen preparation and test procedure.

While packaging can span many industries, The seal strength of medical packaging is extremely important for two reasons

First to ensure that the packing can be opened easily by the medical professional, and second to ensure that the adhesive is strong enough to prevent any breaches

of the packaging prior to their use.

During shipping and storage the adhesive must remain viable to maintain sterilization:

Any breach in the packaging would desterilize the product potentially leading to life threatening infections for the patient.

*** Before conducting EN  868-5, it is important to read the entire specification. Standards can be obtained from appropriate standard authorities.

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