Medical Device Packaging Standards

Keystone works closely with kentwood mich based packaging compliance labs pcl which validates sterile medical device packaging according to fda recognized standard iso 11607.

Medical device packaging standards.

If you re involved in medical device packaging you ve got a lot of support these days with even more on the way. Expected transit life includes processing handling sterilization transit and warehousing. Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr. 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.

Enter consensus standards into their search engine and follow the links to their standards database. These regulations specify the minimum requirements for all devices. Packaging for terminally sterilized medical devices. The table below lists the medical device packaging standards recognized by the fda.

Testing intensity is determined based on the specific device and system. 2019 packaging for terminally sterilized medical devices was just published in february 2019 and iso ts 16775 the guidance on the application of iso 11607 is now being revised. The latest revision of iso 11607 1 2. The standard has three main pillars according to ryan erickson a packaging engineer at pcl.

Medical device packaging standards will play a fundamental role in the safe delivery of treatment from the manufacturer to its final clients. General device labeling 21 cfr part 801 use of symbols. 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. 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.

If not properly planned for upfront packaging can significantly delay timelines. Most medical devices are packaged either in a pouch or a tray. For a complete list of all standards recognized by the fda visit their site at www fda gov. 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.

Here is a breakdown of the design sterilization testing requirements and validation processes medical device companies need to consider when tackling a packaging project.