Medical Device Packaging Standards

Expected transit life includes processing handling sterilization transit and warehousing.

Medical device packaging standards.

Enter consensus standards into their search engine and follow the links to their standards database. Typical distribution simulation for medical devices is defined in astm d4169 standard practice for performance testing of shipping containers and systems dc 13. For a complete list of all standards recognized by the fda visit their site at www fda gov. Recently the fda added the tougher ista 3 packaging and transport standards as the official standards for all medical device and radiation emitting machines packaging in the u s.

If you re involved in medical device packaging you ve got a lot of support these days with even more on the way. For these reasons it is important to choose the proper packaging to ensure the integrity of the product and to prevent damages during the distribution cycle. Medical device packaging standards will play a fundamental role in the safe delivery of treatment from the manufacturer to its final clients. Both the fda and international regulatory bodies emphasize on compliance with iso 11607.

Testing intensity is determined based on the specific device and system. Packaging for terminally sterilized medical devices. Keystone works closely with kentwood mich based packaging compliance labs pcl which validates sterile medical device packaging according to fda recognized standard iso 11607. This standard defines the test requirements necessary to ensure that the terminally sterilized package device will maintain its design performance over the intended life of the product and will not degrade as a result of sterilization shelf.

The table below lists the medical device packaging standards recognized by the fda. The standard has three main pillars according to ryan erickson a packaging engineer at pcl. At nefab we have fully adopted these standards for all of our packaging solutions and our global ista certified test labs work hard to apply the proper. Here is a breakdown of the design sterilization testing requirements and validation processes medical device companies need to consider when tackling a packaging project.

If not properly planned for upfront packaging can significantly delay timelines. The latest revision of iso 11607 1 2. Most medical devices are packaged either in a pouch or a tray. The general labeling requirements for medical devices are contained in 21 cfr part 801.

General device labeling 21 cfr part 801 use of symbols.