Medical Device Packaging Standards

The latest revision of iso 11607 1 2.

Medical device packaging standards.

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. 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. The table below lists the medical device packaging standards recognized by the fda. Enter consensus standards into their search engine and follow the links to their standards database.

The standard has three main pillars according to ryan erickson a packaging engineer at pcl. These regulations specify the minimum requirements for all devices. Typical distribution simulation for medical devices is defined in astm d4169 standard practice for performance testing of shipping containers and systems dc 13. The general labeling requirements for medical devices are contained in 21 cfr part 801.

Expected transit life includes processing handling sterilization transit and warehousing. Here is a breakdown of the design sterilization testing requirements and validation processes medical device companies need to consider when tackling a packaging project. Testing intensity is determined based on the specific device and system. 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.

Both the fda and international regulatory bodies emphasize on compliance with iso 11607. If you re involved in medical device packaging you ve got a lot of support these days with even more on the way. Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr. 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.

For a complete list of all standards recognized by the fda visit their site at www fda gov. Keystone works closely with kentwood mich based packaging compliance labs pcl which validates sterile medical device packaging according to fda recognized standard iso 11607. If not properly planned for upfront packaging can significantly delay timelines. General device labeling 21 cfr part 801 use of symbols.

Packaging for terminally sterilized medical devices.