Packaging for sterilization
The certification of packaging for terminally sterilized medical devices is a process in which a third independent party (certification body) may be involved to assess the conformity of the product with the type inspection according to the requirements of the ISO 11607-1 standard (and subordinate product standards – for example, for Sealable pouches and reels of porous materials and plastic film construction in accordance with standard EN 868-5, and related standards – for example, for the application of risk management to medical devices in accordance with ISO 14971).
For certification purposes, we conduct a review of all requirements, performing some of the required tests ourselves, while for the others, we identify suitable testing laboratories.