ISO 11608 Has Been Completely Renewed for 2022.
Sections 1 to 7 of the combination device standard ‘Needle based injection systems for medical use’ have been updated.
A lot has happened and there is a lot to absorb. To assist you in the application of this document MET is publishing a series of frequently asked questions. They can be found in the combination device section of our FAQs area.
They will help explain changes in the standards with a particular emphasis on testing and validation.
Our laboratories at MET keep a watch on the progress of standards and how any changes apply the required test work. We even have members of our team the technical committees : ISO/TC 84 Devices for administration of medicinal products and catheters and ISO/TC 194 Biological and clinical evaluation of medical devices.
This all ensures that we are up to date and therefor your testing recommendations and work is up to date.