Medical Device Testing and ISO 11607

If your company manufactures healthcare products that need terminally sterilized packaging, medical device testing and ISO 11607 are very important. These guidelines set by the International Standards Organization are in place to make sure that packaging for these devices offers protection and sterility until the customer opens the package. Let’s check out some important points to remember about 11607.

Four Important Testing Requirements

ISO 11607 requires four kinds of medical device testing procedures. There are as follows:

 * Stability – products may be tested after aging, and the aging is real or accelerated.

 * Dynamics/performance tests

 * Packaging strength

 * Package integrity

The Importance of Worst Case Testing

Did you know that testing has to be done under worst case conditions? For example, if temperatures in the production area vary considerably, testing should be done in temperatures with the worst possible effect on the packaging. Also, if any other factors can affect packaging integrity, they must be part of the testing procedure. This is the best way to ensure that the packaging can survive all the stages in the supply chain, including, shipping, storage, and moving.

Packaging with Double Pouches

Although some companies practice double pouch packaging, it’s not part of the medical device testing requirements for ISO 11607. In some cases, this is a good way to make sure your packages can meet the standards. The most important consideration is to be sure that the package cannot adversely affect the health of the user.

Product Inserts and Instructions for Use Materials

When testing, it’s very important to include the IFU materials. The reason for this inclusion is simple. Many IFU sheets are simply inserted into packaging containers. During transit, they may shift about and can cause package damage (especially if they contain staples). When you make sure that all data sheets are included in the testing, you protect yourself from possible product liability lawsuits.