Medical Device Packaging

ISO 11607: "Packaging for terminally sterilised medical devices", includes requirements for the development and validation of the packaging process and for evaluating the performance of packages.

EN 868: "Packaging materials and systems for medical devices that are to be sterilised" covers the materials and design of the packaging.

It is likely that these two medical packaging standards will be at least partially harmonized at some point.

Pira are UKAS, ISO 17025 accredited for the majority of the testing detailed in EN 868.

Contact the Expert

  • Mark is the materials laboratory manager with twenty years experience in paper and board research and testing, covering the full paper production cycle from pulp to converting and end use.

    Mark Taylor
    Mark Taylor

    Laboratory Manager

    Pira International

    +44 (0)1372 802147

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