Medical   -   Determination of Shelf life

ISO 11607-2:2006 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.

ISO 11607-2:2006 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized.

Other than this various standards for evaluation of  shelf life for Ophthalmic lenses and elastomeric seals exists and Eurotech helps client in third party validation of Shelf Life of such products according to established international standards

 

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