Pira Consulting
Packaging Testing
Medical device packaging (EN 868 and ISO 11607)
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.
Related testing
For further information contact
Malcolm Shill
T +44 (0)1372 802114
M
F +44 (0)1372 802245