Medical Devices

Smithers Pira can support medical devices and their packaging with a wide range of tests, both standard and custom. 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 are UKAS, 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.