Medical Devices

In addition to the EMC testing that Medical Devices must undergo, they should also be tested for transportation safety. These medical devices are often expensive and fragile. It is imperative that they reach their destination safely. In many cases, the medical devices are sterile. With tests designed specifically for sterilization and general transportation safety, Keystone can help ensure the medical devices reach their destination to provide the lifesaving purposes for which they were designed. For medical devices, package validation testing is outlined in ISO 11607. The test consists of seal integrity (seal strength), material integrity (bubble leak), distribution testing, and package aging.

From manufacturer to end user- hospital, doctor’s office, patient, etc.- a medical device will undergo stresses throughout the distribution process. Package testing will test the ability of a package to withstand the predictable stresses that they will encounter throughout distribution. Often, medical device packaging is designed to maintain sterility. Breach of sterility can result in returns, replacement costs, and loss of customer trust. Fortunately, Keystone can help prevent loss of package integrity through simulating the predictable stresses. The simulated stresses mimic some of the things that can be expected such as temperature changes and rough handling.

Regarding sterilization of the medical device, one of the most common test standards is ASTM F2096 Standard Test Method of Detecting Gross Leaks in Packaging by Internal Pressurization, also known as the Bubble Test. This test measures the material integrity of the package and is performed by submerging the package under water and increasing the internal pressure of the package. When doing this, any holes in the packaging or seal will release air and result in bubbles. The test is very useful for measuring the effectiveness of package seals for a complete seal that will keep the device sterile.

In some cases, medical devices may require a packaging system that will maintain its integrity when exposed to extreme environmental conditions. Keystone Compliance has experience with cold chain packaging and is able to perform conditioning tests to see how well a package will perform under certain environmental conditions. For example, throughout distribution, a package could experience high amounts of humidity or extremely high temperatures inside a truck. You want to make sure that the package does not warp or collapse when conditions are not ideal.

The standards listed below are most commonly used for medical devices to ensure safety and sterilization throughout the distribution process. This is not an exhaustive list of our medical device package testing capabilities. If you are looking for a specific test that you do not see on this list, please search our site for that standard or request a quote.

Companies partner with us for package testing because of our high-quality work. We take pride in being a full-service testing laboratory that delivers accurate testing and reports in a timely fashion. Our customers appreciate the transparency and experience that we bring to every test. Please contact us or request a quote. We look forward to working with you!