Medical product packaging testing is required for medical device manufacturers who must obtain 510 (k) approvals on each of their medical product packages. It is important to have your medical product packages tested to make sure they meet ISO standards. It is up to the manufacturer of medical products to evaluate their packages to see that these packages are capable of providing full protection to the products they contain.
From handling to distribution to storage, these packages must be strong enough to withstand all the normal events that are closely associated with product distribution without causing defects or loss of sterility. The product must remain in its proper orientation so that it is safe to remove and then be used by the customer. You can get more information about package integrity testing from various sources over the internet.
Proper medical product packaging testing should simulate all normal events that are closely associated with product distribution. After testing, the packages should have passed eligible for further secure distribution. After testing has been done and the package has passed the testing process, it will be certified to meet various industry standards, including ASTM standards and of course ISO standards.
Several tests need to be performed, including the package integrity and strength test. The tests must be able to demonstrate the integrity of the packaging. You must demonstrate that the product in the package will remain sterile until it has reached its endpoint of use and the package must also have microbial barriers in the post-sterilization environment.