Medical Devices

Medical device packaging presents a variety of performance and safety challenges that must be verified to industry standards.

We can test to the following requirements, although it is likely that these two medical packaging standards will be at least partially harmonized at some point.

  • 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.
Standards and Accreditation

Smithers Pira's laboratories are ISO 17025 accredited for the majority of the testing detailed in ISO 11607-1 and EN 868

To view the full range of Medical Device Testing services we offer, please view our Medical Device and Packaging Testing section.