Flow and leak testing are required for any medical device that brings a substance to or from the body. Flow testing ensures that there are no blockages and the substance being delivered can make it through. Leak testing determines if a product leaks, and in some cases, where it leaks and by how much.
In most cases, every product coming off the assembly line must be tested. However, this means manufacturers must balance the time it takes to test with the increased risk from lower “passing” standards. While leak and flow testing are intended to keep consumers safe, they can be an unnecessarily complicated step for medical device manufacturers.