Medical product packaging tests are required for medical device manufacturers who are required to obtain 510(k) approvals on each of their medical product packages. It is important that you test the packaging of your medical products to ensure that they meet ISO standards.
It is up to the medical product manufacturer to evaluate their packages to see that these packages can provide full protection to the products contained within them. They therefore use packaging testing procedures to insure the quality and safety of their products.
From handling to distribution to storage, these containers must be durable 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 correct orientation so that it is safe to remove and then use by the customer.
Proper medical product packaging testing should simulate all of the normal events that are closely associated with product distribution. After testing, the packages should have passed as eligible for safer distribution. Once the test has been performed and the package has passed the testing process, it will be certified as meeting various industry standards, including ASTM standards and of course ISO standards.
There are several tests that need to be performed, including package strength and integrity testing. The tests must be able to show the integrity of the packaging. You must demonstrate that the product in the package will remain sterile until it has reached its end point of use and the package must also have microbial barriers in the post-sterilization environment.